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UNIVERSITY COLLEGE LONDON

UCL TERMS 2011-2012

FIRST TERM Monday 26 September 2011 - Friday 16 December 2011

SECOND TERM Monday 9 January 2012 - Friday 23 March 2012

THIRD TERM Monday 23 April 2012 - Friday 8 June 2012

UCL CLOSURES

CHRISTMAS CLOSE: Friday 23 December 2011 at 5.30pm

RE-OPEN: Tuesday 3 January 2012

EASTER CLOSE: Wednesday 4 April 2012 at 5.30pm

RE-OPEN: Wednesday 12 April 2012

OTHER BANK HOLIDAYS

Monday 7 May 2012 Monday 4 June 2012 Tuesday 5 June 2012

Monday 27 August 2012

Reading Weeks for 2011/2012: 7 – 11 November 2011 13 – 17 February 2012

Undergraduate Pilot Plant Week: 13-17 February 2012

Departmental Photograph: 12 October 2011

Team Briefings:

6 October 2011

8 March 2012

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CONTENTS Page Number

1 Introduction 1 2 Masters Degree Programmes 2 2.1 MSc in Biochemical Engineering 2 2.2 Modular MSc in Bioprocessing (IGDS) 6 2.3 Internationalisation 7 3 Course Regulations 8 3.1 Attendance at Lectures 8 3.2 Absence from College 8 4 Supervision/Departmental Functions 9 4.1 Members of Academic Staff and Responsibilities 9 4.2 Tutoring 10 4.3 Members of Administrative Staff 10 4.4 Common Timetabling 10 4.5 Team Working 11 5 Student Feedback and Welfare 12 5.1 Postgraduate Staff-Student Consultative Committee 12 5.2 Course Evaluation 12 5.3 Student Welfare 12 6 Assessment 13 6.1 Types of Assessment 13 6.2 Examinations 13 6.2.1 Calculators 13 6.2.2 Exam Results 13 6.3 Coursework 13 6.3.1 Coursework Hand in Procedures 14 6.4 Degree Course Assessment Guides 17 6.4.1 MSc in Biochemical Engineering (Engineering Stream) 17 6.4.2 MSc in Biochemical Engineering (Science Stream) 18 6.4.3 Modular MSc in Bioprocessing (IGDS) 18 7 Facilities 19 7.1 Libraries 19

7.2 Computer Facilities and Email 19 7.2.1 Conditions of Use 19 7.3 Pilot-Plant Activities 20 7.4 ACBE Building 20

8 Safety and Security 21 8.1 Security 21 9 Planning Your Future 22 9.1 Notes on CV Preparation 22 9.2 IChemE 23 10 Student Groups 24 10.1 The UCL Graduate School and Graduate Society 24 10.2 The Beaker Society 24

11 Miscellaneous 25 11.1 Notices 25 11.2 Mail 25 11.3 Change of Address 25 11.4 Lockers 25 11.5 Location of Lecture/Teaching Rooms 25

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APPENDIX 1 PORTICO Module Registration and Information 27 APPENDIX 2 Module Descriptions 32 APPENDIX 3 Recommended Text Books 59 APPENDIX 4 Coursework Cover Sheet and other Forms 62 APPENDIX 5 BBSRC Masters Training Grant Forms 69

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1. INTRODUCTION

Welcome to the Department of Biochemical Engineering at UCL and to The Advanced Centre for Biochemical Engineering (ACBE). We hope that you will enjoy your postgraduate year in the Department and have prepared this handbook to provide key information which will be of use to you during your time here. The purpose of the booklet is to give you the basic details and relevant points of contact to help ensure that you get the most from your degree. It should be read in conjunction with the Departmental Safety Handbook and Quality Assurance documentation. In drawing together information for this booklet we have tried to include all that we believe is relevant and useful. The Head of Department is Professor Nigel Titchener-Hooker. The Department also hosts The Advanced Centre for Biochemical Engineering (ACBE) an internationally recognised research centre comprising more than 10 other Departments at UCL and a similar number of other university collaborations in the UK. As a new member of the Department you need to be aware of the two separate sites on which we operate. Members of academic staff are located in each area. • Roberts Building (lecture theatres, computer rooms and labs). • ACBE (labs and pilot-plant). You should also be aware that the latest information on the MSc programme, course timetables and notices are to be found on the departmental intranet (www.ucl.ac.uk/biochemeng/intranet) which you should check regularly, along with the notice board outside Room 310 in the Roberts Building. Good luck with your studies!

Dr Frank Baganz: MSc Programme Organiser and Engineering Stream Tutor

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2. MASTERS DEGREE PROGRAMMES 2.1 MSc in Biochemical Engineering Two distinct MSc degree programmes are offered in the Department: (a) MSc in Biochemical Engineering for graduate scientists (Engineering Stream); (b) MSc in Biochemical Engineering for graduate engineers (Science Stream). The flowchart on Page 4 outlines the components of each stream. Both programmes provide students with the opportunity to understand how advances in the life sciences can most effectively be translated into real outcomes of benefit to all. Close linkage of the Master’s programmes with the research activities of The Advanced Centre for Biochemical Engineering (ACBE) ensures that lecture and case study examples are built around the very latest biological discoveries and bioprocessing technologies.

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Biochemical Engineering and New Bioprocess Challenges (45)

• Bioprocess synthesis and mapping • Heat and mass transfer in bioprocesses • Fluid flow and mixing in bioprocesses

Appraisal and Application of Advanced Life Sciences (45)

• Metabolic processes and regulation • Applied cell and molecular biology • General biochemistry

Advanced Biochemical Engineering (45)

• Advanced bioreactor engineering • Integrated downstream processing • Cell culture and stem cell processing

Bioprocess Design and Implementation (15)

Design, planning, conduct and analysis of a full pilot scale bioprocess

Advanced Bioprocess Research (45)

• Bioprocess research project • Research project business appraisal • Bioprocess validation and quality control

Advanced Bioprocess Design (45)

• Bioprocess creation and analysis • Bioprocess design and economic appraisal • Bioprocess validation and quality control

Management of Bioprocess Ventures (30)

• Commercialisation of bioprocess research • Bioprocess entrepreneurial business plan

Science Stream Engineering Stream

MSc in Biochemical Engineering

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(a) MSc IN BIOCHEMICAL ENGINEERING (ENGINEERING STREAM) This course is specifically designed to allow first degree biological scientists and biotechnologists to achieve recognised status in biochemical engineering. The course is recognised by the Institution of Chemical Engineers (IChemE, Section 9.2) such that after a suitable period of relevant training the successful graduates may become Chartered Engineers (CEng) and Members of the Institution (MIChemE). It comprises a conversion element in addition to biochemical engineering and pilot plant studies and an advanced design project. Course Structure The flow chart on Page 4 shows the structure of this degree programme and the individual topics studied. The numbers in parenthesis indicate the credit hours associated with each element of the course. 180 credits are required in order to be considered for the award of the MSc degree. For assessment purposes the Advanced Bioprocess Design and Bioprocess Implementation elements are combined in a 60 credit dissertation. The programme is divided into four distinct but integrated parts: Conversion Elements: Biochemical Engineering Fundamentals and Bioprocess Challenges (BENGG001, BENG G016, BENGG017: 45 credits) The material here is designed to provide science graduates with the fundamentals of process engineering relevant to the handling of biological materials. Students learn, for example, the principles of how to calculate nutrient requirements for industrial scale microbial conversion processes and how to predict and control the environment in which cells have to survive and grow. We also build upon the students’ knowledge of the structures of biological polymers and show how this can be used to predict the stress damage which may occur when delicate biological materials are processed at scale. Advanced Biochemical Engineering (BENGG004, BENGG005, BENGG006: 45 credits) These core elements of the course cover the detailed design of biological conversion processes, i.e. fermentation and biotransformation, and the subsequent recovery, purification and formulation of therapeutic products. Lecture and case study material is supported by a series of experiments on individual unit operations which are complemented by a week-long course in the department’s pilot-plant. Here students make use of all the Centre’s facilities to learn how to plan and execute whole sequences of complex operations. The material in this element of the course is designed to provide students with the ability to take the results of new life sciences, such as gene therapy, tissue engineering, metabolic pathway engineering, and translate them into real process outcomes. Dissertation: Advanced Bioprocess Design and Bioprocess Implementation (BENGGD99: 60 credits) The design module involves the application of the skills and information gained in the above elements to a group design project. For graduate scientists who wish to proceed towards Chartered Engineer (CEng) status this is a vital part of the course. The project involves the complete design of a bioprocess, together with economic and safety analyses, and the establishment of process validation methodologies. The choice of target products are closely linked to the research activities of the Advanced Centre and, in recent years, have included the manufacture of plasmid DNA, a hepatitis B vaccine, novel polyketide antibiotics and chiral pharmaceuticals. Management of Bioprocess Ventures (BENGG018, BENGG008: 30 credits) This element of the MSc programme reflects the growing need for qualified biochemical engineers to be equally aware of the issues involved in the establishment and management of small, high-tech Biotechnology companies. The material covered here is based around a number of real industrial case studies and culminates in the production and presentation of a business plan for the translation of a life science discovery into a real outcome. Course Appraisal The conversion and biochemical engineering elements of the programme are assessed by written examinations in May/June. The bioprocess management and pilot plant studies are assessed by a combination of case study reports, oral and poster presentations throughout the year. The bioprocess design projects are assessed by written theses and oral presentations throughout the summer. There is also a final oral examination on the day of the MSc Examination Board meeting which is held in mid-September to provide the final course assessment.

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(b) MSc IN BIOCHEMICAL ENGINEERING (SCIENCE STREAM) This course is specifically designed to allow first degree chemical and process engineers to gain a recognised training in biochemical engineering. It comprises a conversion element in addition to biochemical engineering and pilot plant studies and an advanced research project (optionally students may elect to take a bioprocess design project in place of the research project). Course Structure The flow chart on Page 4 shows the structure of this degree programme and the individual topics studied. The numbers in parenthesis indicate the credit hours associated with each element of the course. 180 credits are required in order to be considered for the award of the MSc degree for assessment purposes the Bioprocess Research Project and Bioprocess Implementation are combined in a 60 credit dissertation. The programme is divided into four distinct but integrated parts: Conversion elements: Appraisal and Application of Advanced Life Sciences (BENGGB01, BIOCG005, BENGGB03: 45 credits) The material here is designed to provide engineering graduates with fundamental knowledge of standard molecular biology techniques, applied cell biology and the biology of stem cells, all within the context of today's biochemical engineering-led industries. Students also learn how to use molecular biology to rationally engineer changes to the properties of biocatalysts, biopharmaceutical host cells and whole-cell therapeutics in order to bring about process improvements. Lecture materials are supported by tutorials and practical classes in which key concepts are explored, explained and put into practice. Advanced Biochemical Engineering (BENGG004, BENGG005, BENGG006: 45 credits) These core elements of the course cover the detailed design of biological conversion processes, i.e. fermentation and biotransformation, and the subsequent recovery, purification and formulation of therapeutic products. Lecture and case study material is supported by a series of experiments on individual unit operations which are complemented by a week-long course in the department’s pilot-plant. Here students make use of all the Centre’s facilities to learn how to plan and execute whole sequences of complex operations. The material in these elements of the course is designed to provide students with the ability to take the results of new life sciences, such as gene therapy, tissue engineering, metabolic pathway engineering, and translate them into real process outcomes. Dissertation: Bioprocess Research Project and Bioprocess Implementation (BENGGR99: 60 credits) Each candidate usually carries out an original research project, of their choice, under the supervision of a member of academic staff. During this time the Master’s students are fully integrated into the activities of one of the multidisciplinary research teams within the Advanced Centre. Research projects are often co-supervised by staff in associated UCL departments such as Biochemistry and Molecular Biology, Chemistry, or Electrical Engineering and, on occasion, are linked to ongoing industrial collaborations. Students complete a written thesis and undergo an oral examination. Engineering graduates may opt to take part in the bioprocess design project activity (BENGGD99) in place of the research project. Management of Bioprocess Ventures (BENGG018, BENGG008: 30 credits) This element of the MSc programme reflects the growing need for qualified biochemical engineers to be equally aware of the issues involved in the establishment and management of small, high-tech Biotechnology companies. The material covered here is based around a number of real industrial case studies and culminates in the production and presentation of a business plan for the translation of a life science discovery in to a real outcome. Course Appraisal The conversion and biochemical engineering elements of the programme are assessed by written examinations in May/June. The bioprocess management and pilot plant studies are assessed by a combination of case study reports, oral and poster presentations throughout the year. The bioprocess research projects (or optional design projects) are assessed by written theses. There is also a final oral examination on the day of the MSc Examination Board meeting which is held in mid-September to provide the final course assessment.

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2.2 Modular MSc in Bioprocessing (IGDS) The Department runs a series of part-time courses for those already in the international bioindustry which build towards a range of UCL accredited qualifications in Bioprocessing from Diplomas to an MSc in Bioprocessing. This is termed an Integrated Graduate Development Scheme (IGDS) which we refer to as the MBI® Training Programme (http://www.ucl.ac.uk/biochemeng/industry/mbi/). The courses are all taught at Masters level and are for industrialists requiring post-experience training. The courses offered in 2010/2011 are listed below. A number of the course elements are taught alongside the full-time MSc students. This provides for a high level of interaction between the different streams and is a very positive feature of the courses. In addition, the full-time students benefit from the provision of full sets of lecture notes derived directly from the MBI® courses. A small charge is made for these notes in order to cover the cost of printing. Anyone wanting to know more about the MBI® Training Programme should contact the MBI Manager, Ms Elizabeth Barrett (Ext: 31316).

Training Course

Timetable

Principles of Fermentation Processes 5th - 7th October 2011

Rapid Fermentation Process Design: From Development to Manufacture

17th - 19th October 2011

Challenges and Opportunities in Industrial Biotechnology: Biocatalysis and Synthetic Biology

31st October - 2nd November 2011

Primary Recovery 14th - 17th November 2011

Chromatography 28th November - 1st December 2011

Vaccines Bioprocess Development and Commercialisation 14th December - 16th December 2011

Mammalian Cell Processes 30th January - 1st February 2012

Stem Cell and Regenerative Medicine

20th - 22nd February 2012

Quality by Design for Effective Bioprocess Characterisation and Validation

27th February - 1st March 2012

Design of Experiments for Bioprocess Optimisation

12th - 14th March 2012

Effective Biopharmaceutical Development & Manufacture

14th - 16th May 2012

Design & Economic Evaluation of Bioprocesses

11th - 14th June 2012

Bioprocess Facility Design 18th - 21st June 2012

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2.3. Internationalisation of the Curriculum Biochemical Engineering as taught at UCL has particularly broad global implications. Firstly, the Department has an extremely strong research interest in the means by which new medicines are brought to the patient. In all countries, people’s expectations for better health are in danger of outstripping the resources which can be made available. This challenge can only be met if the huge costs of development typically £1/2 billion per new medicine, can be reduced. The time taken, typically 10 years is also too long to benefit many of those in need. Only if costs can be reduced in the development and production of new medicines will they become available globally. The 21st Century is about a time when non-renewable resources will come under even greater pressure as the world exhausts accessible materials. In this situation renewable biological sources will become ever more crucial. Though the promise of much of the new science related to this is great only by creating efficient large scale methods will this make a real contribution. Our intake of students at all levels is multicultural, multiethnic and multinational and the same is true of our staff – at all levels we surely aim for the best talent. In that situation our vision is inherently global and it fits with the vision of UCL which has from its inception always welcomed people from all classes, all religions or none and all ethnic groups, even those who at the time were often non-conforming. We believe that you will find it exciting and satisfying. All aspects of the course seek to address these global issues wherever relevant. In particular within design which is a major component of all accredited degree programmes. During the extensive team work activity students explore the technical and economic implications of operating facilities in a truly global sense – for example examining the likely consequences of operation in developing countries were new modular routes for construction may be indicated if local expertise does not really exist. The products we examine are intrinsically of international significance e.g. vaccines. Finally by working together in teams students learn about the different national backgrounds that often shape decision making in such global enterprises. Global implications of the emergence of new diseases are discussed along with the role of Biochemical Engineers in combating them. The responsibility of the World Health Organisation (WHO), governments and pharmaceutical companies are also discussed in terms of social, economic and ethical issues, along with the reality of responsive pharmaceutical manufacturing. Challenges such as cost of research and development, supply of raw materials, plant capacity and adaptability, rapid clinical development, patent restrictions versus shared information, and the impact of global distribution are also studied.

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3. COURSE REGULATIONS

3.1 Attendance at Lectures Lectures form a fundamental aspect of all Masters courses and you must attend them. Students are expected to attend all lecture courses in order that they may make the desired academic progress in their subjects. Students who receive an external grant, e.g. BBSRC or EPSRC studentships, should note that failure to attend lectures may be grounds for termination of an award. Students may enter for examinations only if their lecturers certify that they have attended the appropriate course and pursued it to the lecturer’s satisfaction. Attendance will therefore be monitored on a weekly basis. Please refer to the relevant timetable for your particular course for the time and location of each lecture. In addition, keep a close watch on the Departmental notice board (third floor, Roberts Building) and your UCL email account for notification of any change to lectures (Section 11.1). We will try to keep such changes to a minimum but this is not always possible. The Department also regards satisfactory attendance and behaviour at tutorials, case studies and any relevant laboratory work as obligatory. 3.2 Absence From College Students who are absent from College for more than two consecutive days must immediately inform the MSc Tutor (Section 4.2) and give a reason for their absence. Students whose absence is prolonged for one week or more must also report to their MSc Tutor on their return to College, bringing with them a medical certificate where appropriate. The MSc Tutors have a duty to report matters of illness etc., which may affect academic performance, to the relevant Sub-Board of Examiners for consideration when recommending marks and levels of achievement. These factors can only be considered if a medical certificate or similar documentation is available. It is very important that if you fall ill, or have some other problem which interferes with your studies, you do not delay before you inform your MSc Tutor. Please note the Masters course is 12 months in duration and there is not normally any free time during the Summer period as this is dedicated to design project and research studies. Tempting though it may be you must not take vacations during the degree (beyond the College breaks!) without the express permission of your MSc Tutor.

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4. SUPERVISION/DEPARTMENTAL FUNCTIONS

4.1 Members of Academic Staff and Responsibilities The members of academic staff in the Department, their contact details and main training/administrative responsibilities related to the Masters programmes are given in the table below.

Name and Contact Details Location Training (See App. 2)

Administration

Dr Frank Baganz f.baganz@ucl.ac.uk Ext. 32968

Room 2.6 ACBE

MSc Engineering Stream Tutor, Chair, Safety Committee

Dr Dan Bracewell d.bracewell@ucl.ac.uk Ext. 32374

Room 116b Roberts Building

BENGG001, BENGG016

MSc Admissions, Chair, Consultative Committee

Dr Paul Dalby p.dalby@ucl.ac.uk Ext. 32962

Room 113 Roberts Building

BENGGB03

Dr Suzanne Farid s.farid@ucl.ac.uk Ext. 34415

Room 3.4 ACBE

Prof Mike Hoare m.hoare@ucl.ac.uk Ext. 33795

Room 2.5 ACBE

Prof Eli Keshavarz-Moore e.keshavarz-moore@ucl.ac.uk Ext. 32961

Room 313 Roberts Building

BENGG006, BENGG018,

Prof Gary Lye g.lye@ucl.ac.uk Ext. 37942

Room 116a Roberts Building

BENGG004 MSc Co-ordinator Vice Chair Exam Board

Prof Chris Mason chris.mason@ucl.ac.uk Ext. 30140

Room 118a Roberts Building

BENGG008

Dr Martina Micheletti m.micheletti@ucl.ac.uk Ext. 33778

Room 2.9 ACBE

Pilot Plant Week

Dr Tarit Mukhopadhyay ucbetkm@ucl.ac.uk Ext 30438

Room 3.2b ACBE

Pilot Plant Week

Dr Nicolas Szita n.szita@ucl.ac.uk

Ext. 34418

Room 2.7 ACBE

Prof Nigel Titchener-Hooker Nigelth@ucl.ac.uk Ext. 33796

Room 3.1 ACBE

BENGG005 Head of Department Chair Exam Board IChemE Contact

Dr Farlan Veraitch f.veraitch@ucl.ac.uk Ext. 32648

Room 222 Roberts Building

BENGG017 BENGGD99

Dr Ivan Wall i.wall@ucl.ac.uk Ext. 33918

Room 223 Roberts Bldg

BENGGB03

Dr Yuhong Zhou y.zhou@ucl.ac.uk Ext. 33815

Room 3.3A ACBE

BENGG001 Lab Demonstrators

Dr Darren Nesbeth d.nesbeth@ucl.ac.uk Ext. 33507

Room 112a Roberts Building

BENGGB03 BENGGB01 BIOCG005

MSc Science Stream Tutor

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4.2 Tutoring The Masters course has two Course Tutors (one for the Engineering stream and one for the Science stream cohort), who handle all administrative matters such as timetabling and collection of marks as well as playing a pastoral role. At UCL we do not have fixed times for postgraduate students to meet with the course tutors and it is up to each person to make suitable arrangements to do so. Whilst we will do our best to see you please remember that tutors can be busy so don’t turn up and expect an immediate audience - you may need to book a time in advance preferably by email. The MSc Tutors should be the point of first contact if you experience academic problems with a particular course. During the first week of term the MSc Tutors will hold an introductory lecture. MSc Engineering Stream Tutor: Dr Frank Baganz MSc Science Stream Tutor: Dr Darren Nesbeth The Faculty Tutor, Dr Marco Federighi. Marco is a member of the academic staff of the Department of Electronic and Electrical Engineering academic and pastoral oversight of all students in the Faculty of Engineering Sciences. Marco’s office is located in Room 3.01, 3rd floor, Front Engineering Building. 4.3 Members of Administrative Staff Administrative staff of the Department of Biochemical Engineering is located in the Departmental Office, Room 115 on the 1st floor of the Roberts Building. Office hours are 9am to 5pm, Monday to Friday. Some administrative staff is also located on the 1st floor of the ACBE building. Their office hours are 9am to 5pm, Monday to Friday, except for an hour at lunch-time from 12.30pm to 1.30pm. The Departmental Administrator, Miss Anne Wilson (Ext. 33782) is also located in the Biochemical Engineering Departmental Office, Room 115, 1st floor of the Roberts Building.

4.4 Common Timetabling The UCL Online Timetable (www.ucl.ac.uk/timetable) displays your personal timetable week by week, and lets you find out what is being taught, when, where and by whom across UCL.

To see your personal timetable or find out when things are being taught, visit the UCL Online Timetable at www.ucl.ac.uk/timetable.

The UCL Online Timetable at www.ucl.ac.uk/timetable lets you see your personal timetable week by week and can be used to find out when things are being taught across UCL. Use it to select course units which will fit in your timetable. Your personal timetable will display all the course units you are registered to attend including lectures, seminars, tutorials, labs, film screenings, computer training and more. Check it regularly for changes to dates, times or locations.

Login with your standard UCL username and password to display your personal timetable, or select a department or subject area, a degree programme, or individual modules and create a custom timetable, to find out when things are scheduled to be taught.

Four Types of Timetable

• Personal timetables for students and teaching staff with a UCL username and password. • Department or Subject Area timetables by year of study. • Degree programme timetables by year of study. • Custom timetable lets you choose modules to create a timetable.

Features

• display a week, term or year • click back and forth through weeks or select a week • 3 sizes of event display to choose from • click on an event to open pop-up box and see all details • link to UCL maps route finder by clicking on the room • students can display all groups timetabled for their modules, by default only groups they are assigned to

are displayed • students and lecturers see all their teaching for all departments in one view

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Personal timetables for students

Your personal timetable displays the modules you are registered to attend in Portico. Students are automatically registered for compulsory modules so they immediately appear in your timetable. Use the Department, Degree Programme or Custom timetables to find options that fit in your timetable. Once you select your options in Portico, they will appear in your timetable the next day. If a module selection is rejected or deleted in Portico, it will be removed from your timetable the following day.

Groups such as tutorials, labs and seminars are added to your timetable when you are assigned to a group by the teaching department. You can choose to display all groups for your modules.

Timetables are subject to change, check regularly for any changes to room, day or time. Any change to the timetable from any department at UCL is reflected immediately in the online timetable and your personal timetable will be updated automatically. It is student’s responsibility to check for regular updates.

4.5 Team Working As we all agree Team Working is critical to teaching of biochemical engineering and we must have assessment procedures in place which fairly record contributions of individuals to a team activity and also recognises the pressures and strains which inevitably occur when groups of individuals are expected to work together.

There are several basic guidelines we all seek to follow and it would be useful to get your feedback during upcoming team working exercises that they do provide the necessary confidence.

a) Teams are selected at random b) The method of assignment of team roles is determined by the course manager and this is explained

where appropriate. c) Team activities such as design project, enterprise studies, pilot plant week do require each team

member to contribute to help deliver the overall team activity – for these:

i) There is formal observation of the team discussions and team members are marked based on their contribution to these; these discussions should suffice as the briefing needed for individuals to progress to complete their own tasks.

ii) Informal team discussions are not assessed. iii) all written submissions and presentations are assessed as individual effort; where a team

submits a joint document they must ascribe individual authorship to specific sections; in some cases team members will be expected to address identical or similar tasks – again this must be done as individual effort and there must be no copying between the reports.

iv) Where an individual feels unable to progress due to lack of performance of a member of a team they will be advised to record this and either make assumptions on the data needed or seek advice from the course organiser of assumptions to be made.

v) Where other teams are working on similar tasks cross team working is encouraged to help reduce dependence on individual members (e.g. as may happen in the bioprocess validation studies).

d) Activities such as bioprocess validation rely on the use of a team structure to ensure a distribution of

tasks. In this case, several teams work on the same activity and cross team working is encouraged. Hence there is no dependence on individual members and where a team becomes dysfunctional then an individual can easily submit their own report or make their own presentation without being disadvantaged.

e) Team activities such as practical experimentations are run as team activities for administrative purposes

only and it is expected that all members of a team address all tasks and that they submit individual reports. Where the results of the practical are insufficient (e.g. due to the negligence of a team member) the teaching associate will provide alternative data. The teaching associate formally observes the practical and records absences and insufficient contribution.

f) In any of the above cases, while comment may be made on overall team performance there is no carry

over of this to the formal assessment of an individual’s performance.

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5. STUDENT FEEDBACK AND WELFARE 5.1 Postgraduate Staff-Student Consultative Committee This committee consists of postgraduate (MSc, PhD and EngD) and staff representatives with the former elected by their peers. The Committee meets usually once each term to consider matters raised by students and staff. Its remit is to improve the quality of the learning experience and is chaired by Dr Dan Bracewell. The Committee is interested in ideas and suggestions for improvements. Students with a problem should not wait until the next Committee meeting before raising the matter, but should speak to the appropriate staff member (or Course Tutor if they are not sure who to approach) at the earliest opportunity. Minutes of each meeting will be posted on the Department notice-board (See 11.1) and on the Intranet. Matters which you feel are beyond the scope of the Committee can be progressed through formal channels. Procedures for grievances and complaints are detailed in the UCL Academic Manual which may be consulted in the Faculty Office. 5.2 Course Evaluation As part of UCL's quality assurance programme “Teaching Questionnaires” are used to obtain valuable feed back from students upon the various aspects of the courses and teaching. Teaching Questionnaires are issued towards the end of each course, or parts of a course, and are anonymous. The responses, collated and summarised by the member of staff responsible for the course, are submitted to the Head of Department for consideration and action if required. 5.3 Student Welfare The welfare of each student is of crucial importance. In addition to the MSc Tutors the College provides a number of specific services designed to ensure that your time at UCL is a happy one. The Dean of Students (Dr Ruth Siddall, ext 32758) co-ordinates all aspects of student welfare in the College and is available to give individual advice and help to students about personal, academic, social etc., problems. The Dean is also responsible for keeping good order within the College. The Advisers to Women Students (Dr Hilary Richards, Ext: 40882) is especially concerned with the welfare and social needs of women at UCL. (Advisers are available for individual consultations to discuss any problem be it academic, social or personal.) The Student Counselling Service (1st Floor, 3 Taviton Street, Ext: 21487) provides specialised counselling and support for students of UCL. (Advisers are available for individual consultations to discuss any problem be it academic, social or personal.) A Medical Practice (UCL Health Centre building at 3 Gower Place, Ext: 32803 / 37057) provides a full range of NHS services. Reception is on the 2nd floor. The practice is open from 9am to 5.30pm Monday to Friday and there is an emergency surgery from 9.30am to 10.00am on Saturday. Students are advised to register here or with a GP close to where they are in lodgings. The Dental Centre under the NHS, (Fifth floor, UCL Health Centre building at 3 Gower Place, ext 37186). The Centre provides dental treatment under the NHS and is open from 9am to 5pm, Monday to Friday, including UCL holidays. Appointments can be made by telephone.

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6. ASSESSMENT 6.1 Types of Assessment The courses offered by the Department are assessed in a variety of ways. This ensures that the assessment of the students’ work is not limited to a narrow range of assessment techniques. Components include: • Formal written examination • Formal oral examination • Coursework assignments • Assessed project work Examiners attach great importance to legibility, accuracy and clarity of expression in both coursework and written examinations. In order to “complete” a course, students are required to satisfy the examiners in all aspects of that course i.e. attendance, coursework and examinations. Students who do not hand in sufficient coursework will be deemed as “not complete” and thus fail the course.

6.2 Examinations Course examinations are held during the third term. You must ensure that you register for the examinations in good time and you will be notified to do this via PORTICO (Appendix 1). Examinations are normally set and marked by the lecturer(s) teaching each course. The exact nature (form and duration) of the examinations will be outlined by the lecturer(s) concerned. Copies of past papers are available for reference in the Science Library (DMS Watson Building). On-line copies are viewable at http:\\exam-papers.ucl.ac.uk. It is the policy of the Department not to provide model answer to past exam questions though members of staff will be happy to comment on questions attempted.

6.2.1 Calculators Regulations for the use of electronic calculators are published by the College. These rules specify the type of calculator that may be used in examinations. Calculators must be of the hand-held type, quiet in operation, compact and with their own power supply; in addition, they must not have alphabetic (text) capability, be able to be programmed by magnetic media or other forms of external storage, or have plug-in elements. Any calculator with keys labelled “A” through to “Z” will be considered to have alphabetic (text) storage capability and is therefore prohibited, even though it may have a memory reset/clear button or buttons. For all the examinations set by the Department, “advanced” but “non-alphabetic” calculators may be used, although other Departments may further restrict their use in examinations. Candidates should note that random checks will be made during examinations to ensure that these regulations are being complied with, and that the use of material stored in a pre-programmable memory could constitute cheating.

6.2.2 Examination Results Final examination results will be available following the MSc Examination Board in mid-September and can be accessed via the UCL student information service PORTICO (ww.ucl.ac.uk/portico). Students in debt to the College or Department or who have not returned all books from the library will have their results withheld until the debt is cleared.

6.3 Coursework An engineering course must include a proper preparation for a professional career, and this in turn means that a student's ability in various skills must be examined in depth. Nowadays, the sheer volume of subject material that a biochemical engineering student must cover means that a single set of examinations, at the end of the course, is not practicable. The method of continuous assessment through coursework used in the Department will allow you to accumulate credit towards your degree as you proceed through your course. Most courses have an aspect of continuous assessment through coursework (e.g. problem sheets, case studies, essays etc) associated with the lectures. This coursework will contribute towards the final marks in a course. Some courses, for example design and research projects, may comprise coursework only. The precise nature of the coursework that you will have to complete and an indication of its weighting will be given

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by the lecturer(s) for each course. It is essential that you give full attention to coursework throughout the MSc programme. Students must be deemed “complete” in all parts of each course to qualify for the MSc degree. If a student fails to submit sufficient work in any aspect of the course, then the student is deemed “not complete” and gains no marks or credit for the course whatsoever. Thus for example, if a student takes an examination but fails to submit sufficient coursework or submits sufficient coursework but does not complete the examination, the student will be deemed “not complete” and will fail that course (see also Section 6.3.1). The Departmental guideline for lecture courses is that a minimum of 50% of the coursework set should be attempted and submitted before a student's coursework is deemed “complete”. In laboratory and computing courses this minimum becomes 75%. It is, however, up to the lecturer(s) in each course to determine exactly what is sufficient for completion and, therefore, what is deemed sufficient may vary from course to course. Students should also note that different departments and faculties may have different rules and guidelines of what constitutes completion. Some require that answers be submitted to all coursework set. Therefore, students taking courses in other departments should make themselves aware of what is required. Students are strongly advised to attempt and submit answers to all coursework set. Submitting an incomplete or incorrect answer and getting appropriate feedback is better than submitting none. 6.3.1 Notes on Coursework Hand In Procedures

(a) PREPARATION It is strongly recommended that you present your coursework in word-processed form unless otherwise instructed. You will not be penalised if you do not do so. If you present handwritten work, your script must be legible. Computers are available for student use on campus, and you should become familiar with their location. All pages must be clearly numbered.

IMPORTANT: You are advised that you must deal with the set deadlines for handing in coursework by managing your time effectively. The deadlines are given out at the beginning of the term. Absence from teaching sessions is not acceptable because there is an impending coursework deadline. Please note the new submission time for coursework will now be 12pm on the given date of your coursework deadline – NO COURSEWORK WILL BE ACCEPTED AFTER THIS TIME.

(b) SUBMISSION

Coursework Cover Sheets

Your work MUST be clearly labelled with:

Your name

Lecturer’s name

Course title and code number

Name of MSc Tutor

Your signature

Ensure that a Coursework Cover Sheet is attached to your work. Copies of this form can be found in the UG/MSc Handbooks, the Departmental Intranet and also in the computer room in the second floor of the Roberts Building.

Failure to provide a signed coversheet

The assignment coversheet has information on plagiarism/collusion and privacy. Submission of your assignment WILL NOT be accepted unless you have attached a signed coversheet. Assignments without a signed coversheet WILL NOT be marked or returned. The date of submission will be recorded as the date on which the signed coversheet was provided, and any late penalties will be applied accordingly. Please staple the pages in the top left-hand corner. Please do not submit assignments in folders or plastic covers, unless otherwise stated.

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Procedures for handing in coursework

Procedures may differ for handing in coursework in other departments: it is student’s responsibility to check with the course unit coordinator or tutor which Departmental/School Office to submit the coursework to.

Students are to submit coursework to the Departmental Office using the drop off box (see details below) and provide ONE copy of coursework, with a completed and signed Coursework Cover Sheet attached.

Unless specified otherwise do not submit an assignment directly to tutors. Coursework is also not to be sent to the Departmental Office by post, fax, or email. Submission of coursework in any of these forms will not be counted as a submission. Do not ask another person to submit your assignment unless you are certain that they will do so.

Always keep a disk copy of any assignment you submit, to guard against the rare event of your work going astray. If you are not able to provide a copy within 24 hours on request, it will be assumed that the work was not handed in.

Please note the new deadline for coursework submission on a daily basis is 12pm. Please check with your tutor when coursework deadlines are and ensure the work is submitted before 12pm on the given day. Any coursework received after 12pm on the selected day for deadline will be penalised as late coursework (see Penalties section).

Coursework drop off box: Dept of Biochemical Engineering Office: Room 115, 1st Floor Roberts Building

(c) EXTENSIONS

Extensions may be granted by the MSc Tutors, usually only on medical grounds. A medical certificate or equivalent will be required. If you are taken ill and need to arrange an extension, contact the MSc Tutor as soon as possible. Extensions must be agreed BEFORE the submission date. Copies of the request for extension forms can also be found in student handbooks and are also posted on the Intranet. It is the student’s responsibility to ensure this form is completed and presented to the MSc Tutor.

(d) SPECIAL CIRCUMSTANCE FORM What service does this form provide? This form may be used for declaring any circumstances you believe may have adversely affected your overall performance during the degree programme. It may not be used for reasons arising from acute, short term circumstances (use the Formal Request for Extension Form here). Special circumstances cannot be mediated more than once. What is a “special circumstance”? The MSc Tutors will consider all factors which may affect a student’s performance as relevant factors for special consideration. These may include long term illness (physical or mental), bereavement, eviction from lodgings, welfare issues etc. The circumstances are not necessarily medical, but they are extraordinary. “Special circumstances” do not include poor planning or a lack of preparation on your part. What is the procedure? Complete the Notification of Special Circumstances Form and submit it along with your supporting documentation to the MSc Tutor, who will discuss your circumstances with the relevant Course Tutor. What kind of supporting documentation will be needed? A medical certificate, verifiable letter from your doctor or completed and stamped. For non-medical conditions, any relevant documentation and, in some circumstances, a letter of explanation from yourself or a third party may be considered. When should I submit the form? Students should keep the MSc Tutor informed and document special circumstances as they arise. The MSc Tutor will accept an application from you at any time during the teaching year, but not less than one week from the end of an examination period in question.

(e) PENALTIES 10% will be deducted for each week, or part thereof, from your mark for coursework which is handed in late without a previously arranged extension. Please note that no allowance will be made where the exacting of penalties may lead to your failing an item of coursework or the Course Module. In addition, if the coursework cover sheet is not completed or is completed incorrectly 5% can be deducted from the mark.

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IMPORTANT: Note that the penalties for late submission of coursework may differ for courses in other UCL departments. Check with the course unit coordinator, and make sure that you know what the penalties are.

Plagiarism, cheating and collusion Plagiarism means to take and use another person’s ideas or work and present these as one’s own by failing to give appropriate acknowledgement. The incorporation of the work of someone else without due identification and reference constitutes plagiarism. Using someone else’s data, material from the internet (e.g. Wikipedia), incorporating portions of text, even extended and very close paraphrasing, without due acknowledgement, are examples of plagiarism. The University takes a very serious view of plagiarism. Collusion: Collusion is the presentation of work that is the result, in whole or in part, of unauthorized collaboration with another person or persons.

Cheating: Cheating means seeking to obtain an unfair advantage in an examination or in other written or practical work required to be submitted or completed by a student for assessment. What we will do Plagiarism and collusion are methods of cheating. It is University policy that where there are reasonable grounds for believing that plagiarism or collusion has occurred this will be reported to the Course Organiser, who will disallow the work concerned by prohibiting assessment or refer the matter to the Faculty Tutor for disciplinary action. Turnitin is the leading academic plagiarism detector, utilized by teachers and students to avoid plagiarism and ensure academic integrity. The Department is rolling out use of Turnitin technology at the start of this academic year so we recommend students familiarise themselves with both UCL policy on plagiarism and the Turnitin detection system. http://www.ucl.ac.uk/current-students/guidelines/policies/plagiarism If a student is found cheating the unit coordinator may either: a) disallow the work and not give it an assessment (i.e., assignments will receive zero), or b) refer the matter to the Faculty Tutor. Unintended plagiarism will be dealt with as poor scholarship, with appropriate adjustments to the assessment.

(f) RETURN OF COURSEWORK & FEEDBACK All coursework will be returned to personal tutors once it has been marked. It is expected that the turnaround time from coursework submission to return to students will be not more than 1 month. It is the MSc Tutors’ responsibility to inform students of how best to collect coursework. The MSc Tutors will give you some form of feedback on the work that you produce; the format of this feedback will not always be the same. Feedback at different points in the course should facilitate self-assessment of how you are meeting learning outcomes. Your task is to analyse your own performance in relation to a set of standards rather than make comparisons with other students. Grade comparisons with other students are often misleading rather than helpful. On the other hand, it might be useful to compare and discuss study methods and learning strategies. Requests for feedback If a student requires further feedback or clarification regarding any aspect of their assessment they should contact the marker. Some markers are not available to be contacted by students; for example, markers may be located off campus, or may have been employed on a ‘marking only’ contract. In such cases, the assignment should be discussed directly with the Module Coordinator. Requests for re-mark It is the student’s responsibility to check marked assignments upon return. Students are expected to raise any queries about their mark, including making a request for a re-mark, within two weeks of return to the students. The following procedure applies to requests for re-marking.

1. Prior to requesting a remark, the student is required to have discussed the corrected piece of work with the marker. If the marker is unavailable for consultation the student can then approach their MSc Tutor.

2. If the student is still dissatisfied, the student may then proceed directly with a request for a re-mark.

3. Re-mark requests must be made in writing to the MSc Tutor, documenting the specific grounds for a re-mark. Re-mark requests must include the originally marked work and an identical “clean” copy. Any request considered vexatious or frivolous will be rejected. The MSc Tutor shall, where possible, nominate an independent marker to mark the “clean” copy of the work. The final mark awarded shall be at the discretion of the MSc Tutor. Students should note that re-marking can result in an increase or decrease in marks.

4. If a student is still dissatisfied, an appeal should be made first to the Director, Postgraduate Studies. If necessary, any further appeals will be referred to the Head of Department, whose decision is final.

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Departmental Office Hours

Normal hours of work for this Department are 9.00am to 5.00pm Monday to Friday. 6.4. DEGREE COURSE ASSESSMENT GUIDELINES 6.4.1 MSc in Biochemical Engineering (Engineering Stream)

Elements of Assessment

Total Weighting (Credits)

Element Number

Course Code Course Title

Exam (%) Coursework Etc (%)

1 BENGG004 Advanced Bioreactor Engineering

80 20 15

2 BENGG005 Integrated Downstream Processing

70 30 15

3 BENGG006 Commercialisation of Bioprocess Research

70 30 15

4 BENGG018 Mammalian Cell Culture and Stem Cell Processing

0 100 15

5 BENGG008 Bioprocess Entrepreneurial Business Plan

0 100 15

6 BENGG001 Bioprocess Synthesis and Process Mapping

80 20 15

7 BENGG017 Heat and Mass Transfer in Bioprocesses

80 20 15

8 BENGG016 Fluid Flow and Mixing in Bioprocesses

80 20 15

9 BENGGD99 Dissertation on Bioprocess Design

0 100 60

MSc Pass For the award of the MSc degree candidates are required to attain: (a) a minimum of 50% in each element, and (b) a minimum overall average mark of 50%. To pass an individual module it is required to pass both examination and coursework elements. Intra-module compensation is possible for marks between 40-49% to be condoned for up to 50% of the assessment providing that an overall mark of 50% or more is achieved. The MSc Examination Board can, at its discretion, condone marks between 40-49% in a maximum of 25% of the taught assessment (2 elements) not including the dissertation (element 9). MSc Merit For the award of a merit candidates are required to attain: (a) a minimum mark of 65% in element 9, and (b) a minimum overall average mark of 60%. A merit cannot be awarded where a candidate has failed any module. The award of a merit is at the discretion of the board. MSc Distinction For the award of a distinction candidates are required to attain: (a) a minimum mark of 70% in element 9, and (b) a minimum overall average mark of 70%. A distinction cannot be awarded where a candidate has failed any module. The award of a distinction is at the discretion of the board. Diploma Pass Element 9 is not included in the Diploma assessment thus for the award of a diploma candidates are required to attain: (a) a minimum of 50% in elements 1 to 8, and (b) a minimum overall average mark of 50%. A maximum of 25% of assessed work may be condoned at 40-49%.

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6.4.2 MSc in Biochemical Engineering (Science Stream)

Elements of Assessment

Element No.

Course Code

Course Title

Exam (%) Coursework Etc (%)

Total Weighting(Credits)

1 BENGG004 Advanced Bioreactor Engineering

80 20 15

2 BENGG005 Integrated Downstream Processing

70 30 15

3 BENGG006 Commercialisation of Bioprocess Research

70 30 15

4 BENGG018 Mammalian Cell Culture and Stem Cell Processing

0 100 15

5 BENGG008 Bioprocess Entrepreneurial Business Plan

0 100 15

6 BENGGB01 Metabolic Processes and Regulation

90 10 1F5

7 BIOCG005* General Biochemistry 80 20 15

8 BENGGB03 Applied Cell and Molecular Biology

70 30 15

9 BENGGR99 Dissertation on Bioprocess Research

0 100 60

*this course code is subject to change. MSc Tutors will inform students of any changes. MSc Pass For the award of the MSc degree candidates are required to attain: (a) a minimum of 50% in each element, and (b) a minimum overall average mark of 50%. To pass an individual module it is required to pass both examination and coursework elements. Intra-module compensation is possible for marks between 40-49% to be condoned for up to 50% of the assessment providing that an overall mark of 50% or more is achieved. The MSc Examination Board can, at its discretion, condone marks between 40-49% in a maximum of 25% of the taught assessment (2 elements) not including the dissertation (element 9). MSc Merit For the award of a merit candidates are required to attain: (a) a minimum mark of 65% in element 9, and (b) a minimum overall average mark of 60%. A merit cannot be awarded where a candidate has failed any module. The award of a merit is at the discretion of the board. MSc Distinction For the award of a distinction candidates are required to attain: (a) a minimum mark of 70% in element 9, and (b) a minimum overall average mark of 70%. A distinction cannot be awarded where a candidate has failed any module. The award of a distinction is at the discretion of the board. Diploma Pass Element 9 is not included in the Diploma assessment thus for the award of a diploma candidates are required to attain: (a) a minimum of 50% in elements 1 to 8, and (b) a minimum overall average mark of 50%.

A maximum of 25% of assessed work may be condoned at 40-49%.

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6.4.3 Modular MSc in Bioprocessing (IGDS) For details of the assessment of the IGDS programme please contact the MBI® Programme Administrator, Ms Elizabeth Barrett (Ext. 31316).

7. FACILITIES

7.1 Libraries The School Library, accessed via the School of Process Engineering Office, contains the major chemical and biochemical engineering journals and textbooks. Books and journals, not designated For Reference Only, may be borrowed. Take the book to the School Office where it will be checked out in your name. You will then be responsible for its safe return. A maximum of four books may be borrowed at any one time. The Library is open during the office opening hours, i.e. 9am to 5pm, Monday to Friday, except for an hour at lunchtime from 12.30pm to 1.30pm. Briefcases, bags, etc. are not allowed in the Library. These may be safely stored in your locker (Section 11.4). A list of recommended textbooks and suggestions for books you may wish to purchase, are given in Appendix 1. The DMS Watson Library, which contains a wide range of science and engineering books and periodicals, is situated just to the rear of the Roberts Building. 7.2 Computer Facilities and Email The general computer laboratories 203A and 209, are open to all students of the School of Process Engineering. The laboratories are open during office hours, Monday to Friday, 9am to 6pm. All postgraduates must vacate the laboratories by 6pm. Due to the load upon the computer rooms a booking scheme is used. Details of the scheme and the booking sheets are posted upon the notice board Room 203A. A large open access computer facility can be found on the ground floor of the DMS Watson Library. The Department also has two further computer rooms, Interactive Design Suite 1 (Roberts Building) and the Innovation Suite (ACBE). Access to these is related to particular parts of the MSc programme. Interactive Design Suite 1 is available for student use whenever it is not being used for teaching or training. A timetable for the week ahead will be posted on the IDS door each Monday morning. A wireless network RoamNet is in operation in most areas of the department and in many open access areas of the college. This provides full access to UCL web-based resources. Each student will be given a user-id and password, which should not be lent to others. These user-ids allow the users to use the computers in the departmental laboratories and any of the computers in UCL's public cluster rooms. All students will have access to e-mail and should check it regularly as this is the official line of communication between staff and students. Users should not waste computer time and resources on, for example, playing games, excessive use of the printers and plotters, wasting disk space and paper, etc. Each student is allowed 80 copies per term with any extra use being charged for. Use is monitored automatically on each account. You can check your printing credit online at any time via this link: https://printcharging.ucl.ac.uk/ At no time may students load illegal or “pirated” software on the College or departmental computers. Anyone found doing this will have their access terminated forthwith as a minimum penalty. 7.2.1 Conditions of Use ALL users are required to respect the copyright of all materials and software made available by the Department and by third parties, and to abide by the COPYRIGHT ACT 1956, THE COPYRIGHT (COMPUTER SOFTWARE) AMENDMENT ACT 1985 and THE DATA PROTECTION ACT.

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Users must not delete or in any way alter the system files nor may they copy software onto or from departmental computers. No work of a commercial nature or for reward may be performed upon departmental computers. No food and drink is allowed in the computer laboratories at any time. In order to keep the department’s computers in the best possible condition, it is necessary to impose a ban on eating and drinking when using shared computer facilities. This will in particular apply to the following areas:

• Interactive Design Suite (IDS) of the Centre for Micro Biochemical Engineering (Roberts Building), • Innovation Suite (ACBE) Anyone found ignoring this code will have their computer accounts suspended.

ANY USER WHO BREAKS THESE CONDITIONS OF USE OR IN ANY WAY ABUSES THESE FACILITIES MAY BE BANNED FROM THEIR USE REGARDLESS OF WHETHER OR NOT THIS MEANS THAT THE USER MAY FAIL ANY COURSES REQUIRING THE USE OF THE FACILITIES. Full details of the College Computer Regulations are given in the College’s Information for Students booklet.

7.3 Pilot-Plant Activities You will be involved in large-scale practical studies during your course at UCL. Your safety during these sessions is of paramount importance. Please wear appropriate laboratory coats and safety glasses at all times when in either a laboratory or the pilot-plant areas. Do not commence any practical work without having read and understood the Departmental Safety Regulations (See Section 8). 7.4 ACBE The Advanced Centre for Biochemical Engineering (ACBE) is located in the Bernard Katz Building. Entry to the ACBE is gained by the use of electronic swipe cards that will be issued to new MSc students at the start of term.

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8. SAFETY AND SECURITY Many of the activities of the Department have potential dangers unless sensible precautions are taken at all times. The Department's safety regulations are contained in the departmental Safety Handbook which is issued to all students. All experiments have been assessed for their COSHH (Control of Substances Hazardous to Health) compliance. All postgraduate laboratory work must be supervised by an appropriately trained demonstrator. Postgraduates must not work unsupervised in laboratories or attempt operations for which they are not trained. The Departmental Safety Officer is Ms Elaine Briggs (Ext. 33831) and the Genetic Manipulation Safety Officer is Professor Eli Keshavarz-Moore (Ext. 32961). Dr Frank Baganz (Ext. 32968) is Chair of the Departmental Safety Committee. 8.1 Security

Students are expected to carry their ID cards at all times whilst on campus and will need them for access to certain areas of the department. For safety and security reasons, unsupervised undergraduates and taught postgraduates are not allowed in the Department outside the Department’s normal hours of work. Special security measures apply to the Advanced Centre for Biochemical Engineering (ACBE).

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9. PLANNING YOUR FUTURE 9.1 Notes on CV Preparation At the end of January each year we will be circulating to a wide number of companies, both in the UK and abroad, CVs of Masters students interested in obtaining full-time employment within the bioprocessing industries, including the food, antibiotic, and biotechnology sectors. This is a considerable exercise and is one main route by which recent students in biochemical engineering at UCL have gained employment. We must emphasise that it is just one route and is certainly no substitute for making direct application to companies. You must follow up all reasonable avenues to make the most of available job interviews. Do not worry that a company might hear of you through several routes. What is important is to realise that the first impression given to a company will be via your CV and, if relevant, your covering letter. Very great care is needed when preparing a CV to ensure that a company does not get a false, and often derogatory, impression of your abilities, character and suitability for employment. It is for this reason that the following guidelines are made available. Please read them carefully. The following guidelines on preparation of CVs apply to both draft and final versions. A number of draft versions will probably be required. Members of staff are willing to comment on the draft versions of your CV, but only if all the instructions listed below have been followed. The deadline for completion of the final versions of your CV will be announced by your Course Tutor. General Points on CV Preparation (i) Prepare CV in type using a word processor. (ii) The CV should be no more than two sides - insert PTO to end of first page. (iii) Leave at least 2.5 cm margin at left-hand side, and 1.5 cm at top, bottom and right-hand side. (iv) Decide carefully on choice of headings, sub-headings, etc. (v) Anyone with a foreign-sounding name who does not require a work permit in the UK should say so

explicitly. (vi) Check all spelling and grammar. Members of staff are willing to comment on draft copies of your

CV, but poor spelling and grammar will make constructive comment very difficult. (vii) All telephone numbers should be listed with STD codes. Add extension numbers where necessary. (viii) Add post-codes to addresses. (ix) Do not narrow down the kinds of work you will accept by written statements. You probably don't

know enough to be doing so and it could immediately exclude you from interviews where you would do well enough to be offered alternatives.

(x) Do not make your CV an ego trip; that is, only include relevant information. (xi) Note that your CV needs to be of use for ~ 12 months. This will require careful attention when giving

addresses and telephone numbers. (xii) Do not try and hide "missing" years. Personnel officers are experts at counting up the years and will

always require you to account for your time. General Information Required for Your CV (i) The University/Departmental address is given below. Contact details of academic staff that will

normally be happy to act as referees were given in Section 4.1. The Advanced Centre for Biochemical Engineering Department of Biochemical Engineering University College London Torrington Place London WC1E 7JE, UK (ii) Mention if you are a student member of the Institution of Chemical Engineers. NOTE that it is an

Institution, and NOT an Institute.

(iii) Do NOT give the departmental phone number as a means of contacting you or even leaving messages.

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Layout and Content The following points are recommended as a guideline for the preparation of CVs. You will obviously need to put yourself in the position of a prospective employer and decide which aspects of your background and attributes you wish to emphasise. (i) First section should include personal details that you believe to be relevant i.e.: name, age, date of

birth, nationality, marital status, address (term-time), plus other address and corresponding phone numbers.

(ii) Schools and universities attended, with dates. (iii) Educational qualifications - give summary A-level results. (iv) While listing courses is dull there is a need to describe the skills they bring e.g. a knowledge of

fermentation, ability to be numerate, a capacity to work in a team (on the design project), a capacity to learn a new subject.

(v) Work experience - only a brief description is required unless the work was technical or showed special initiative.

(vi) Interests and activities - this is often used as a topic for discussion. Be reasonably brief here but try to pick out topics which indicate your spread of interests. Try to be upbeat and sound interesting!

(vii) Date your CV. (viii) When there are many applicants for jobs you might at least consider whether a personal statement in

the CV is worth while. These are dangerous things if you are self-indulgent or go over the top but if you make a case that your training allows you to offer specific skills then this may be helpful in gaining an interview. The following can be used to describe elements of the MSc degree which you feel to be crucial. You might like to explain what biochemical engineering or bioprocessing is, especially in relation to biotechnology, i.e. “biochemical engineering provides the necessary process engineering principles for the biotechnology-based industries”. Point out the relationship to chartered engineering status: “biochemical engineering is accepted by the Institution of Chemical Engineers as a suitable training for a chartered engineer when followed by the usual period of appropriate industrial training”. Describe aspects of your design project or research project. Also describe pilot-plant experimentation including pilot-plant week.

Preparation of Final Version of CV (i) FINAL versions of your CV on diskette in Word format must be completed by the prescribed date.

This will just allow time for copying and collating ready for distribution at the end of January. This will be the only major distribution. Thereafter CVs will be distributed to companies only at their direct request.

(ii) For this purpose we will retain the master copy of the CV and will prepare copies as required. This service is free.

(iii) Please note that the final version of your CV is absolutely your responsibility. You should get a "friend" or colleague to check all your spelling and grammar.

(iv) The master CV must be typed and please remember to leave suitable margins and add PTO at the end of the first page. The CV is not to exceed two sides. (v) A list of companies to whom CVs have been sent will NOT be available; it may be viewed on

request, but not copied. We have spent a great deal of time evolving this list specifically for you and do not want the advantage this confers to UCL graduates being diluted by the list becoming widely known.

Sending of CVs on an Individual Basis The covering letter is as critically important as the CV. If it can show insight into the company by reading an annual report, say, this will help. Try the Careers Office and if not write for one or look on the web. Don't overplay this insight. This is the best place also to incorporate a personal statement provided it is prepared with care.

9.2 IChemE

The Institution of Chemical Engineers (IChemE) is the professional body that looks after the professional interests of biochemical engineers in this country. All students are encouraged to join in with the activities of the IChemE by becoming Student Members. It is hoped that all engineering graduates, after a suitable period of industrial experience, will become corporate members of the IChemE and hence attain Chartered Engineer status (CEng). Prof. Nigel Titchener-Hooker will act as your proposer for membership and can help with the forms which are very simple. More information on IChemE is available from the Institution’s web site (www.icheme.org)

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10. STUDENT GROUPS Students are encouraged to take advantage of some of the many College and University sporting clubs and societies, including the departmental Beaker Society. It is, however, important to find a balance between work and play. 10.1 The UCL Graduate School and GradSoc The College has established the UCL Graduate School which is responsible for postgraduate matters throughout the College. The head of the Graduate School is Prof. David Bogle and the Graduate School Office is located in the Wilkins Building near the main library. The UCL Graduate Society (GradSoc) is concerned with academic and social aspects of the College’s postgraduate community and organises a number of tours and events each term. Further information on both the Graduate School and Grad Soc can be found on the UCL website (www.ucl.ac.uk/gradschool).

10.2 The Beaker Society The Beaker Society is the Biochemical Engineering postgraduate organisation existing within the Department. It was created specifically to promote interaction between the differing postgraduate activities within the department (MSc, PhD and EngD) and across the two sites. It is run by an elected committee and incorporates representatives from all sections of the Department. It now serves two major functions. The first and more serious is as an informal method of raising any relevant moans, or suggestions for improvement, directly with the relevant staff, and as such functions side by side with the Staff-Student Consultative Committee (Section 5.1). So, if there is something you feel is silly, and ought to change, let your representative know! The second, and generally more interesting function, is the organisation of social events. The society organises at least one event a month, and they range from Treasure Hunts (pub crawls), through ten pin bowling, paint balling, to the annual Barbecue and Christmas Dinner. The society is also affiliated to the UCL Union, giving members access to facilities such as the Union’s desk top publishing suite, and allowing some events to be subsidised. Since the society is also involved with the Graduate Society, there are a number of joint events with other departments around the college organised each year. Membership of the Beaker Society costs a nominal amount a year, and lets you participate in society events at a discount: on average a student attending just two events a year will be saving money! Beaker Society representatives will also contact you during the induction week activities!

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11. MISCELLANEOUS 11.1 Notices Departmental announcements, all timetable changes and other course announcements will appear on the Departmental Notice Board located on the third floor of the Roberts Building outside Room 310. You should get into the habit of checking this notice board on a regular basis. Careers and employment notices are placed on an adjacent notice board outside Room 310A. Specific opportunities will be communicated by e-mail and through internal post.

11.2 Mail Written communications addressed to individual students (e.g. notes from academic and administrative staff) will be placed in the pigeon-holes located on the third floor of the Roberts Building outside the 309 lecture theatre. Similarly, you may leave notes for your lecturers and tutors in their pigeon-holes in the Departmental Office or contact them by email. Students should not use the College address for their private correspondence but should use their residential address for such correspondence. 11.3 Change of Address Any changes of home or term-time address should be immediately entered on to PORTICO. It is vital that we keep up to date contact information on you in case of an emergency. 11.4 Lockers Lockers suitable for the storage of lab coats, books, small cases, and other personal belongings are available for hire and are located in the ACBE lobby. You are strongly advised to use a locker as, regrettably, the theft of personal possessions is not unknown. Locker details and keys (subject to a small deposit) will be issued during the first week of term. 11.5 Location of Lectures/Teaching Rooms Maps of UCL and the surrounding area are available on the UCL website. Please check out the location of your lectures before the event so that you don't arrive late at lectures.

• Anatomy = Lecture Theatre (on Gower Street, approximately mid-way between the main UCL entrance to the quadrangle, and the junction between Gower Street and Torrington Place. The entrance is marked "Biological Sciences").

• Archaeology = Lecture Theatre in the Institute of Archaeology, Gordon Street, opposite the

Bloomsbury Theatre. • AV Hill = Lecture Theatre in the Medical Sciences building (building above the tunnel/arch near the

DMS Watson Library). • Bedford Way = Various rooms, 26 Bedford Way. • Biochemistry = Lecture Theatre in the Dept of Biochemistry (on Gower Street, approximately mid-

way between the main UCL entrance to the quadrangle, and the junction between Gower Street and Torrington Place. The entrance is marked "Biological Sciences").

• Chadwick Room 218 = Entrance via the Chadwick Building at the UCL entrance gates to the

quadrangle. • Bland Sutton Lecture Theatre and Seminar rooms = Riding House Street, near the Middlesex

Hospital. • BS Cluster 316 = Cland Sutton Cluster room 316

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• Chemistry Auditorium = Chemistry Auditorium, Christopher Ingold Building (Gordon St). • Chemistry Lecture Theatre = Christopher Ingold Building (Gordon St). • Christopher Ingold various rooms = Entrance on Gordon Street opposite Bloomsbury Theatre. • Cruciform Lecture Theatre and Seminar rooms = The entrance is on Gower Street, opposite (i.e.

on the other side of the road from) the main UCL gates. • Darwin = Lecture Theatre in the Dept of Biochemistry (on Gower Street, approximately mid-way

between the main UCL entrance to the quadrangle, and the junction between Gower Street and Torrington Place. The entrance is marked "Biological Sciences").

• Drayton House = There are various teaching rooms in this building, at the end of Gordon Street,

(i.e. on the corner of Gordon and Euston Road, close to Euston Station). • Edward Lewis Lecture Theatre = Windeyer Institute. This is on Howland St, beyond Charlotte St. • Embryology Lecture Theatre = on Gower Street, approximately mid-way between the main UCL

entrance to the quadrangle, and the junction between Gower Street and Torrington Place. "Anatomy Building" (turn right as you enter the building).

• Foster Court = various rooms in Foster Court, 1st floor. The entrance is opposite the DMS Watson

Library. • Galton Lecture Theatre = 1st floor, 1-19 Torrington Place • Garwood Lecture Theatre = South Wing, Main Building • Haldane LT = Wolfson House, Stephenson Way. Go under the Euston Rd underpass at Euston Sq.

Continue down Gower Street on the other side of Euston Road. First turning on the right is Stephenson Way.

• HM cluster 1 = Henry Morley Building cluster room 1. This is the School of Library, Archive and

Information Studies located behind the Medawar Building.

• Harrie Massey LT = in the student union building on Gordon Street on the ground floor. • J Z Young Lecture Theatre = in Anatomy Building, Gower Street. • Lankester Lecture Theatre = in Medawar building behind Foster Court. • Mathematics 500 etc. = teaching rooms on 5th floor, Maths building (25 Gordon St). • MPEB 1.02 etc = various lecture theatres, seminar rooms and labs in the Malet Place Engineering

Building (located between the DMS Watson Library and the Roberts Building). • RH 111 = Remax House Room 111, Alfred Place.

• Roberts 106 = Lecture Theatre, first floor of the Roberts Building.

• Roberts 110 = Seminar/Teaching Room, first floor of the Roberts Building.

• Roberts G06 = Sir David Davies Lecture Theatre, ground floor of the Roberts Building.

• Roberts G08 = Sir Ambrose Fleming Lecture Theatre, ground floor of the Roberts Building.

• Gustave Tuck Lecture Theatre = in the Wilkins building (main UCL building), 2nd floor. • Watson Lecture Theatre = Medawar Building - by Foster Court.

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APPENDIX 1

PORTICO: Module Registration and Personal Information UCL has recently introduced a new Student System which is known as PORTICO – The UCL Student Information Service. Access to PORTICO is available to everyone across UCL – both staff and students alike – via the web portal www.ucl.ac.uk/portico. You will need to logon using your UCL user id and password, which are issued to you once you have enrolled. These are the same as the ones used for accessing UCL restricted web pages, UCL email and the Windows Terminal Service (WTS). If you do not know them, you should contact the IS Helpdesk as soon as possible (www.ucl.ac.uk/is/helpdesk). Please remember that passwords automatically expire after 150 days, unless they have been changed. Warnings are sent to your UCL email address during a 30 day period, prior to your password being reset. - You can read your UCL email on the web at www.webmail.ucl.ac.uk - You can change your password on the web, at any time, at https://www.ucl.ac.uk/is/passwords/changepw.htm. Passwords cannot be issued over the phone unless you are registered for the User Authentication Service, see www.ucl.ac.uk/is/helpdesk/authenticate/. We strongly advise that you register for this service. If you have not registered for the User Authentication Service you will need to visit the IS Helpdesk in person or ask them to post a new password to your registered home or term-time address. More information can be found at http://www.ucl.ac.uk/is/helpdesk/. As a student you can take ownership of your own personal data by logging on to PORTICO. In PORTICO you can: • edit your own personal data e.g. update your home and term addresses, contact numbers and other

elements of your personal details; • complete online module registration – i.e. select the modules you would like to study, in accordance with the

rules for your programme of study (subject to formal approval & sign off by the relevant teaching department and your parent department);

• view data about courses/modules - i.e. information on courses/modules available either in your home department or elsewhere to help you choose your optional modules / electives.

• view your own examination results online; As before, any continuing student requiring official confirmation of their results, or any graduating student requiring additional copies of their transcript, should refer to the information for obtaining an official transcript at www.ucl.ac.uk/registry/current/examinations/transcripts/ If you have any comments or suggestions for PORTICO then please e-mail: portico_web_feedback@ucl.ac.uk

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On-line module registration This facility enables you to choose your modules in accordance with the rules for your programme of study. Note that Portico does not include timetabling information, so you should check with the teaching department concerned to ensure that your choice of any optional/elective module does not clash with any of your other modules/classes. In addition, many departments have specific procedures for approving module selections/signing students up so you should ensure that you familiarise yourself with these. The Language Centre, in particular, requires students to go to the Language Centre where their level of language competency will be assessed. You can access the Module Selection screen in Portico via the option ‘Select your modules/course components’ in the Student Academic Details container. Clicking on this option opens the following screen:

The top of the screen shows any compulsory modules which you have to take. To complete the module registration process you should select any optional/elective modules as listed at the bottom of the screen. Clicking on the ‘Select’ button next to the appropriate rule, which will open the optional/elective selection screen.

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Selection screen – optional modules If the rule specifies choosing a module from a defined list (an optional module), you will be presented with a screen as follows:

Click in the ‘Select’ box next to the appropriate module to choose the module(s) you wish to take. To view further details about the module, click on the module name. The rule in the header above the list of modules states how many modules/credits you should choose. You must enter the correct number and then click on the ‘Submit Selections’ button to return to the main screen. To return to the main screen without submitting any selections, click on the ‘Cancel Selection’ button.

Selection screen – elective modules If the rule specifies choosing ‘any undergraduate’ or ‘any postgraduate module’ (an elective module, subject to approval), clicking on the ‘Select’ button next to the appropriate rule on the main screen will open the following screen:

As with the optional module selection screen, the rule in the header will state how many modules/credits you should choose. You should input the appropriate module code(s) in the module box and insert an ‘A’ in the ‘Occ’ (Occurrence) field. Alternatively, you can use the ‘Search’ button to find a module. Use the ‘Submit Selections’ button to enter the modules, or the ‘Cancel selections’ button to return to the main screen without submitting anything.

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Validation/Confirmation of selections Once you have completed all of your selections, ensure that they comply with any ‘Overarching rule’ indicated in the ‘Overarching’ column on the main screen and then click on the ‘Submit Selections’ button on the main screen. Once you have submitted your selections, you will be presented with a final screen, where you can either undo your last change or you can confirm your selections by clicking on the ‘Confirm Selections’ button. Note that once you have clicked on this button you cannot go back – you will then need to contact the departmental office in your parent department to make any amendments to your selections. Following your confirmation, you will be presented with a screen that confirms you have completed the module registration process, listing the modules you have selected. All of your selections are subject to the approval of the teaching department for the module and your parent department. You will receive an automatic email to your UCL email address if any of your selections are rejected and you must ensure that you respond to this by contacting the departmental office in your parent department, whom you should also contact if you wish to amend a selection at any time. You can check on the approval status for each of your modules by clicking on the ‘View Module Selection status’ option in your Student Academic Details container.

For the MSc in Biochemical Engineering (both streams) the programmes of study (programme diet) indicating

core and optional modules are shown below. Programme Diet modules PORTICO The UCL Student Information Service

Department Name Biochemical Engineering Programme Code TMSBENSING01 Programme Name MSc Biochemical Engineering Route Code TMSBENSING01 Route Name MSc Biochemical Engineering Year of study 1 Mode of Attendance Full-time Academic Year 2011 User Help

COMPULSORY MODULES Code Title Value

BENGG004 Advanced Bioreactor Engineering 15 BENGG005 Integrated Downstream Processing 15 BENGG006 Commercialisation of Bioprocess Research 15 BENGG018 Mammalian Cell Culture and Stem Cell Processing 15 BENGG008 Bioprocess Entrepreneurial Business Plan 15

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OPTIONAL MODULES Help text Rule Over-Arching Rule

MSc Science Stream students take a choice of one dissertation

( Take a minimum of 1 modules and a maximum of 1 modules from MEng Biochemical Engineering 1B [BENGGD99 BENGGR99 ] OR

MSc Engineering Stream students only

Take a minimum of 1 modules and a maximum of 1 modules from Bioprocess Design Report [BENGGD99 ] )

MSc Science Stream students only

( Take a minimum of 3 modules and a maximum of 3 modules from Compulsory Science Stream Modules [BENGGB01 BIOCG005 BENGGB03 ] OR

MSc Engineering Stream students only

Take a minimum of 3 modules and a maximum of 3 modules from Compulsory Engineering Stream Modules [BENGG001 BENGG017 BENGG016 ] )

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APPENDIX 2 Module Descriptions

The following pages provide brief details of the individual courses which make up the various degree programmes. You should refer to the code at the top of each page for cross referring with the timetable for your degree which will be issued separately. The weighting of each degree element is also included. Further information and any updates can be found on Portico.

*this course code is subject to change. MSc Tutors will inform students of any changes.

Module Code Module Name

BENG G001 Bioprocess Synthesis and Process Mapping

BENG G004 Advanced Bioreactor Engineering

BENG G005 Integrated Downstream Processing

BENG G006 Commercialisation of Bioprocess Research

BENG G008 Bioprocess Entrepreneurial Business Plan

BENG G016 Fluid Flow and Mixing in Bioprocesses

BENG G017 Heat and Mass Transfer in Bioprocesses

BENG G018 Mammalian Cell Culture and Stem Cell Processing

BENG GB01 Metabolic Processes and Regulations

BIOC G005* General Biochemistry

BENG GB03 Applied Cell and Molecular Biology

BENG GD99 Dissertation on Bioprocess Design

BENG GR99 Dissertation on Bioprocess Research

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Course Code: BENG G001 Title: Bioprocess Synthesis and Process Mapping Value: 15 credits Year: MSc Aims: To provide the basic principles of bioprocess analysis and design.

This will be achieved by first introducing students to the concept of whole bioprocess sequences and process flow sheets. Mass and energy balance techniques for the key unit operations within the bioprocess sequence will then be considered.

Learning Outcomes: The module provides opportunities for students to develop and demonstrate knowledge and understanding in the following areas: • Fundamentals of the principles bioprocess unit operations • Principles of mass and energy balances • Application of mass and energy balances to bioprocessing

Learning time: 150 hours including 45 hours (35 of formal lecture and 10 of problem solving and case

studies), 70 hours of private reading, 35 hours revision Coursework: 5 case study problems Assessment: 3 hour written examination paper (80%); 4-6 pieces of coursework (20%) Synopsis:

• Introduction to bioprocess engineering (4 hours): overview of bioprocess biological systems and molecules, biochemical reaction engineering, bioprocessing

• Bioprocess analysis (5 hours): engineering calculations, processes and variables, mass balance fundamentals, reactions and stoichiometry, energy balance fundamentals

• Fermentation and cell culture (5 hours): growth kinetics I, growth kinetics II, fermentation mass balancing I, fermentation mass balancing II, fermentation energy balancing

• Primary separation processes (8 hours): introduction to solid-liquid separations, homogenisation, centrifugation case study I & II, microfiltration case study I & II, case study review

• Chromatography (5 hours): chromatographic beds and beads, modes of action, analysis of chromatography I, analysis of chromatography II, case study

• Formulation and product dose forms for biological medicines (4 hours) • Bioprocess design case study (4 hours): biofuels to vaccines

Textbooks: “Introduction to Chemical Engineering” by E. V. Thompson & W. H. Ceckler, McGraw-Hill,

1977. “Bioprocess Engineering Principles” by P.A. Doran, Academic Press, 1995.

“Basic Biotechnology” by C. Ratledge, B. Krisiansen (3rd Edition) Cambridge University Press, 2006. “Elementary Principles of Chemical Processes” by R.M Felder and R.W Rousseau (2005 Edition) Wiley 2005. “Molecular Biology and Biotechnology” by Walker and Rapley (5th Edition) Royal Society of Chemistry, 2009.

Prerequisites: A good knowledge of mathematical techniques and physics are required together with a

basic understanding of biological systems. Lecturers: Dr Dan Bracewell (course co-ordinator), Prof Eli Keshavarz-Moore, Dr Yuhong Zhou & Dr

Farlan Veraitch

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Course Code: BENG G004 Title: Advanced Bioreactor Engineering Value: 15 Credits Year: MSc Aims: This course provides students with a detailed understanding of bioreactor design, scale-up

and operation. It considers both whole cell (i.e. fermentation) and enzymatic (i.e. biotransformation) conversion processes for the synthesis of complex materials such as therapeutic proteins, antibiotics, gene therapy vectors and chiral pharmaceuticals.

Particular themes of the course include the interaction of biological catalysts and pharmaceuticals with the engineering environment within a bioreactor, the theoretical basis of process scale-up and scale-down, and the impact of rDNA techniques on bioreactor design and operation. Particular attention is paid to the instrumentation and control of bioreactors and issues underlying biosafety with respect to contained operation.

Learning Outcomes: Following completion of the course, students will have an understanding of:

• how to fully specify bioreactor design characteristics and monitoring and control systems

• how bioreactor operation and scale-up impacts on cell growth and productivity • how the kinetics of both free and immobilised biocatalysts impact on bioreactor

selection and operation • how to relate this fundamental knowledge on bioreactor engineering to industrial

practice • the impact of rDNA techniques on biocatalyst kinetics and bioprocess design

Learning time: 150 hours including 35 hours lectures and 10 hours case studies. Coursework: Two case study reports Assessment: 3 hour written examination (80%); Coursework (20%) Synopsis:

• Stoichiometry of biocatalyic processes: mass balancing, electron balancing and degrees of reduction.

• Modes of bioreactor operation: growth kinetics, batch, fed-batch and continuous operation. Productivity optimisation and cost minimisation.

• Bioreactor design: size estimation, single or multiple vessels, impeller and sparger systems. Design for containment and asceptic operation.

• Bioreactor monitoring and control: instrumentation, on-line and off-line analyses, control algorithms.

• Bioreactor sterilisation: cell death kinetics, batch and continuous systems, filter sterilisation of gasses and liquids, safe and contained operation.

• Oxygen transfer: mass transfer theories and correlations, design for oxygen transfer, bubble size, gas hold-up.

• Mixing and power consumption: power number and impeller design, mixing time and reactor heterogeneity, effect of aeration and broth rheology.

• Effects of shear: influence of shear on hydrodynamics and microorganisms and Kolmogoroff concept of turbulence.

• Issues in process scale-up: effects of heterogeneity and bases for scale-up. • Fermentation process scale down: benefits of process scale down, regime analysis

and strategies for scale down experimentation including process automation. • Fundamentals of biological catalysis: biocatalyst production, biocatalyst form and

implications of rDNA technology. • Biocatalyst kinetics and properties: enzyme immobilisation, kinetics of free and

immobilised enzymes, biocatalyst characterisation. • Biocatalytic reactors: reactor design equations, reactor selection and operation. • Improving bioreactor productivity: implications of two-liquid-phase biocatalysis and

in-situ product removal. • Industrial lectures: impact of microbial physiology on bioreactor performance,

Present and future fermentation trends, Scale-up and scale-down of industrial fermentation processes, Rapid fermentation process development, Industrial applications of biocatalysis, Genetic techniques for biocatalyst improvement.

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Relation to other courses: Courses on microbial metabolism and molecular biology provide background information on

the structure and function of biological catalysts and their engineering for improved process performance.

The course on transport processes provides the fundamental basis for issues such as bioreactor aeration. The bioreactor design skills gained in this module will underpin a subsequent course on mammalian cell culture and processing.

Previous knowledge: Mathematics (and preferably physics) to A-level standard. Reading list:

“Bioprocess Engineering Principle” P.A. Doran, Academic Press, London (1995) “Bioreaction Engineering Principles” J. Villadsen & J. Nielsen, Plenum, NY (1994) “Bioprocess Monitoring and Control” M-N Pons, Hanser Press (1992) “Applied Biocatalysis” Ed. J.M.S Cabral et al, Harwood Academic (1994)

Lecturers: Prof Gary Lye (course co-ordinator), Dr Frank Baganz, Dr Yuhong Zhou, Dr Nicolas Szita

and Dr Paul Dalby. Additional lectures given by external experts or industrial representatives: Prof Colin Ratledge (Hull University), Dr Jim Mills (Xenova Biomanufacturing), Dr Ashraf Amanullah (Genentech), Dr Bo Kara (Avecia), Dr Mark Smith (UCL Chemistry).

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Course Code: BENG G005 Title: Integrated Downstream Processing Value: 15 Credits Year: MSc Aims: To provide training for MSc biochemical engineers, via lectures, case studies and pilot plant

study, in the engineering principles underlying the operations and processes for the recovery and purification of biological materials. The course focuses on how operations need to be integrated to create a whole sequence where issues of ease of operation, safety and environmental impact are considered at the selection stage. Taught alongside industrial delegates this course provides a blend of theory and application supported by insights to cutting-edge developments in the field.

Learning Outcomes: Following completion of the course, students will have an understanding of:

• the reasons for selection of particular operations considered from a whole bioprocess perspective.

• the mechanisms of operation and the key design equations needed for equipment sizing and performance estimation.

• the full implications of operation selection on the robustness of operation and the ease/safety/cost of operation.

• the whole bioprocess operation through practical application of these principles via extended individual and team-based pilot-scale activity.

Learning time: 195 hours including 30 hours of expert lectures; 10 hours of industry expert seminars; 60

hours of coursework preparation and 30 hours of report writing and 65 hours of revision. Coursework: Assessed case studies Assessment: Written examination paper (70%); Oral presentation (10%) Synopsis: The recovery and purification of biological products from complex sources such as

fermentation or cell culture represents the major challenge for the provision of safe and effective materials, for therapeutic use and for industrial applications.

The course is designed to progress through the logic of a bioprocess sequence from basic cell removal through to high resolution purification and formulation.

Particle recovery and purification processes are examined as the early stages in the separation of biological materials. Operations include centrifugation, filtration, membrane separation, precipitation and crystallisation. Complementary extraction operations include liquid/liquid reaction and cell disruption

High resolution purification and finishing operations take the material to final form for use - operations studied include chromatography.

The course is concluded with a summary of how complete recovery and purification sequences may be best put together. This provides the ideal precursor to pilot plant studies and third/fourth year design projects

Case studies in the design of selected operations will form the basis of team exercises to help with the understanding and application of the lecture notes.

Reading list: Mcabe W.L., Smith J.C. and Elliot P. 2000. Unit operations of Chemical Engineering (7th edition). McGraw-Hill, London. Bioseparation and Bioprocessing Handbook (2nd edition). 2007. Edited by Ganapathy Subramanian, Wiley-VCH Verlag, Weinheim. Najafpour G.D. 2007. Biochemical Engineering and Biotechnology, Elsevier, London. Cutlip, M.B and Shacham, M. 2008. Problem solving in Chemical and Biochemical Engineering with Polymath, Excel and MATLAB. Prentice-Hall, London. Doran, P.M. 1995. Bioprocess Engineering Principles. Academic press, London. Perry’s Chemical Engineers’ Handbook (8th edition). 2008. Edited by Perry, R.H and Green, D.W. McGraw Hill, London. Belter, P.A., Cussler, E.L. and Hu, W.S. 1988. Bioseparations: downstream processing for biotechnology. John Wiley & Sons, New York.

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Bailey, J.E and Ollis, D.F. 1986. Biochemical Engineering Fundamentals. McGraw Hill International Editions. London.

Lecturers: Prof Nigel Titchener-Hooker (course co-ordinator), Prof. M Hoare, Prof Gary Lye, Dr Yuhong Zhou, Dr Dan Bracewell and industrial experts: Primary Recovery Aloke Dey-Chowdhury, Pall Life Sciences, Geoff Dunn, Sartorius Stedim Biotech UK Ltd. Colin Day, Millipore, Klaus Mannweiler, Westfalia. Chromatography – Jon Baker– GE Healthcare, Steve Burton – Prometic Biosciences, Paul Brummelkamp – Proxcys, Bo Forsberg – CMC, Ian Garrard – Brunel University, David Johnson – Pall Corporation, Bjorn Hammarberg – ABD Life Sciences Ltd, Karol Lacki – GE Healthcare, Andrew Lyddiatt – Lyddallan Consultancy Limited, Maarten Pennings – Xendo, Marcel Raedts – Proxcys, Christina Paril – BIA Separations. Rolf Frey – Bio-Rad Laboratories GmbH, Lothar Britsch – Atoll, Laurent David, Novasep

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Course code: BENG G006 Title: Commercialisation of Bioprocess Research Value: 15 units Year: MSc Aims: This course is designed to provide a structured approach to understanding the ways in

which a discovery in bioprocessing and the life sciences is taken through to a real outcome. The students will learn about ways of evaluating potential commercial opportunities, selecting an optimal route for their commercial exploitation and constructing business plans in order to raise appropriate funding.

Learning Outcomes: Following completion of the course, students will have an understanding of:

• how to undertake the technical and commercial assessment of research projects. • what it takes to patent research • the requirements for clinical trials • how to asses the manufacturing facilities requirements or outsourcing alternatives • know how to structure a business plan • how to create financial spreadsheets.

Significance: Scientists and engineers working in the bioprocessing and life sciences industries are

routinely required to assess business opportunities, and prepare and justify business plans to raise internal company funds for each stage in the commercialisation of a product from discovery and research to manufacturing and product marketing. This approach is equally valid when an idea is evaluated and taken through to business planning to raise funds for a start-up company.

Learning time: 150 including 35 hours lectures, 45 hours private reading time, 25 hours course preparation

and 45 hours revision time. Assessment: 1 hour written examination (70%) Course work (30%) Synopsis: The bioprocessing and life sciences industries have a number of unique features that

distinguishes them from other fast growing sectors. The contents of the course are designed to achieve the aims outlined above by focusing on the factors and constraints that define successful operations in these industries.

The content includes: • Systematic approach to commercialisation of a concept in bioprocessing/ life sciences.

Assessment of an idea, go, no-go options, planning flow chart. Overview of biopharmaceutical, biotechnology, and diagnostics industries. Structure, characteristics, size and trends. Intellectual property rights and management of product and process patents.

• Definitions, importance to the sector, timelines, impact on product planning, estimated costs. Regulatory requirements. Framework for different sectors of the industry (e.g. Pre-clinical to post licensing), GLP, GMP, GCP compliance, biocontainment needs.

• Market research and marketing strategy. Speed to market considerations, current practices in the sector and future trends. Operations management. Planning of clinical trials and manufacturing, options in production, costing operations, labour requirements and planning. Financial planning.

• Preparation of NPV, discounted cash flow and profit and loss accounts and interpretation of them in this sector of industry. Sensitivity analysis

• Constructing a business plan. Internal company business plan versus external: similarities and differences. Successful management structure and profile, product definition, technology platform and portfolio of IPRs, stages of funding (e.g. seed fund), Gantt chart and milestone preparation, rounds of refinancing, presentation of financial data. Exit route. Insurance. Executive summary.

• Financing solutions • Model of financing structure in a large company in the sector. Nature of alliances. Most

likely sources of financing in start-up companies (e.g. business angels to venture capitalists).

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Reading material: Students are provided with tailored lecture notes by industrial speakers Lecturers: Prof. Eli Keshavarz-Moore (course co-ordinator) and industrial contributors include: Dr Bill

Hornby (independent consultant), Dr Michelle Scott (partner-Unicorn Biologics Limited), Vicki Salmon (partner - IP Asset LLP), Prof. Paul Davis (CSO -Insense Ltd), Dr Mark Richardson (Director – Richardson Associates Regulatory Affairs Ltd), Dr V. Thomas (Director SciTech Engineering), Paul Jones (Director – Cisco)

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Course Code: BENG G008 Title: Bioprocess Entrepreneurial Business Plan Value: 15 credits Year: MSc Aims: Based on the knowledge, including the appropriate business tools, gained from the

Commercialisation of Bioprocess Research course (BENG G006), the student will engage in a small (<5) team to apply the course material to a specific commercial opportunity. The output will be a short presentation and a business plan aimed at raising appropriate funding from either a venture capitalist or a strategic partner e.g. big pharma. The course provides the biochemical engineering student with the necessary knowledge to understand the requirements for successfully pitching a commercial vision anywhere along the spectrum of a spin-out company to within a large multinational organisation. The examples used come from pharma, biotech, vaccines, advanced biomaterials/medical devices and cell-based therapies.

Learning Outcomes: Following completion of the course, students will have an understanding of:

• the commercialisation of a cutting-edge scientific discovery from the laboratory bench through the clinical, scalable manufacturing and commercialisation route into routine clinical practice.

• the preparation of a full business plan, funding requirements and executive summary for a potentially disruptive health-care technology

• the preparation of an investor presentation and an ‘elevator pitch’ for a potentially disruptive health-care technology.

• the evaluation of a potentially advanced medical technology as a commercial opportunity including understanding the Gartner Hype Cycle and producing a detailed SWOT (strengths, weaknesses, opportunities and threats) analysis.

Learning time: Total 150 hours comprising; background reading and data collection (50 hours), lectures (6

hours) participation in mentored workshops (20 hours), preparation for oral presentation (10 hours), preparation of written report (60 hours) and participation in final presentation session (4 hours).

Assessment: Coursework consisting of workshops (40%), formal presentation (10%) and written report (in

the form business plan) (50%) Synopsis: The students will work in groups of no more than five, each student undertaking a particular

role within the newly formed start up company. Workshop sessions act as mentoring sessions for the fledgling companies and are facilitated by an academic staff member and a senior industry figure. Each workshop will focus on a different aspect of company set-up including feasibility studies, financial appraisal, manufacturing, market research and sales and marketing strategy. The students will be provided with a portfolio of information of real world (but anonymous) data upon which to start to draw relevant details for their business plan.

Areas covered include: • the basic science specific to the particular technology • research and development, clinical translation, animal studies, clinical trials, regulation,

timelines • manufacturing/bioprocessing, outsourcing (CMOs and CROs),reimbursement • scientific and commercial advisory boards and geographic locations. • non-dilutional funding, angel investment, venture capitalists/hedge funds and strategic

partners (big pharma and medical device companies). Throughout the course, all the material is based on real world examples and data.

The challenges to successful commercialisation a potentially economically valuable research discovery are thoroughly explored including: • the specific issues for advanced healthcare technologies; lengthy development cycle,

high failure rate, product life, patent thicket/freedom to operate • the translation cycle and translation gaps. Students are expected to produce a SWOT (strengths, weaknesses, opportunities and threats) analysis as part of the final business plan as well as an appropriate sensitivity analysis. The valuation process (e.g. discounted cash flow) is modelled together with that of potentially competing technologies.

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Relation to other courses: This course draws together multiple strands from the entire biochemical engineering MSc programme and selectively focuses and integrates the core components within the context of commercialising a disruptive healthcare technology and their success or failure within the healthcare sector.

Textbook: Commercializing Successful Biomedical Technologies: Basic Principles for the Development

of Drugs, Diagnostics and Devices. Shreefal S. Mehta. Cambridge 2008 Lecturers: Prof. Chris Mason (course co-ordinator) and industrial contributors including Dr. Bill Hornby

(distinguished career in the healthcare sector including various senior management roles at Johnson & Johnson)

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Course Code: BENG G016 Title: Fluid Flow and Mixing in Bioprocesses Value: 15 credits Year: MSc Aims: To provide students with an introduction to the basic transport phenomena required to

analyse and design processes handling labile biological materials. Focus is on the development of a physical understanding of the underlying momentum transport phenomena and upon the ability to apply transport analysis to practical bioprocess-oriented problems. The physical interpretation of the problem will be emphasised via the understanding of the problem’s mathematical solution.

Learning Outcomes: Following completion of the course, students will have an understanding of:

• how to mathematically analyse and interpret given experimental data on a simple flow-related problem and provide a physical explanation of the results obtained.

• how to design a generic flow system by verification of the assumptions made and quantify the pump requirements.

• how to analyse and design a complete chromatography system based on fluid flow. • calculating the power input required for agitation in a stirred-tank fermenter under a

range of operating conditions. • defining conditions for the successful scale-up or scale-down of a fermentation process.

Learning time: 150 hours including 30 hours of lectures and case studies, 10 hours of tutorials, 20 hours of exam revision sessions, 30 hours of coursework preparation and related activities and 50 hours of exam and case studies preparation.

Coursework: 3 written pieces on rheology, fluid flow in pipes and fluid flow in columns, respectively. Assessment: 3 hours written examination paper (80%); Coursework/Lab Practical (20%) Synopsis:

• Introduction and rheology: Definition of transport processes. Basic and derived units and nomenclature. Dimensionless numbers. Physics and maths revision. General aspects of rheology. Newton’s Law. Non-Newtonian fluids and rheology of fermentation broths. Viscosity measurement. Case study: cup and bob and viscometer.

• Fluid flow in pipes: Predicting flow characteristics in pipe systems. Laminar flow and Hagen-Poiseuille equation. Calculating heads in a pipework system. Bernoulli equation. Case study: Bernoulli design problem. Pumping of Liquids (pumps classification, NPSH, cavitation, characteristic curve). Fluid flow and pressure measurement.

• Fluid flow in packed columns: Flow through porous media. Darcy’s Law and Carman-Kozeny equation. Determining column porosity. Estimating pressure drops in packed beds. Effect of particle shape. Concept of wall support and effects of compressible media. Concept of critical velocity. Case study: Pumping and flow in chromatography columns.

• Bioreactor mixing and scale-up/down: Mixing equipment, flow pattern and quantification of mixing phenomena in stirred tanks (power curve). Elements of fluid kinematics and turbulent flow scales. Case Studies: Design of batch sterilisation vessel, small aerated pilot fermenter, scale-up/down of fermenters.

Relation to other courses: This is an ‘enabling’ course. It is introductory and the intention is to introduce students to relationships between material properties and behaviour in (bio)process environment. Students will carry the knowledge gained in this course through to all other bioprocess engineering courses, in particular to the design project.

Pre-requisites: Transport phenomena are based on conservation laws and therefore it is assumed that

students have a basic knowledge of mathematics. A review of physics, vector algebra and, when necessary, an alternative coordinate system is provided.

Source reference material: “Analysis of transport phenomena” by William M. Deen Oxford University Press (1998) “Chemical Engineering” (volume 1) by J.M. Coulson, J.F. Richardson and R.K. Sinnott

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Planned changes to the course: The development of a virtual learning environment using Moodle which includes remote access to lecture notes and other learning material, group discussions after teamwork activities, plagiarism control software, etc. Lecturers: Dr Martina Micheletti (course co-ordinator) and Prof Nigel Titchener-Hooker

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Course Code: BENG G017 Title: Heat and Mass Transfer in Bioprocesses Value: 15 credits Year: MSc Aims: To provide students with an understanding of the basic principles of heat and mass transfer

required to design bioprocesses. Learning Outcomes: Following completion of the course, students will have an understanding of:

• the key design features that determine the heat transfer capability of fermenter. • evaluating the consequences of process changes on the performance of fermenter sterilisation and cooling. • designing a spray drier for rapid drying of heat-labile proteins. • defining conditions for successful operation of a freeze drying process. • the basis for dispersion and mass transfer within packed bed chromatography systems.

Learning time: 150 hours including 32 hours of contact time, a 3 hour exam, 50 hours of reading, 25 hours

of coursework and 40 hours revision. Assessment: 3 hour written examination paper (80%) Coursework (20%) Synopsis: Introduction: Mechanisms and applications of heat transfer.

Steady state heat transfer fundamentals: Resistances to heat transfer. Case study 1: Heat transfer in heat exchangers and fermenter coils. Case Study 2: Evaluation of a cooling system with fermenter jackets.

Unsteady state heat transfer fundamentals: Application to canning operations.

Preservation by rapid drying: Principles underlying the design of a spray drying system. Recent advances in rapid drying technology. The impact of product formulation on spray drying. Case study - Design of a spray drier for drying heat-labile proteins.

Freeze drying: Principles of heat and mass transfer underlying freeze drying. The impact of operating conditions on drying. Impact of product formulation on freeze drying.

Chromatographic theory: mass transfer concepts including film resistance and diffusional effects. Isotherms and the concept of breakthrough curves and frontal analysis for the determination of key parameters. Use of single component and multi-component competitive isotherms.

Relation to other courses: This is an ‘enabling’ course. It is intended to introduce students to transport processes relating to heat transfer. The students will carry the knowledge gained in the course

through to other bioprocess engineering courses including unit operations and design. Previous knowledge: Fluid flow & mixing in bioprocesses Textbooks: “Bioprocess Engineering Principles” by P. M. Doran, Academic Press (1995) “Chemical Engineering Vol.1” by J.M. Coulson, J.F. Richardson, Elsevier (2005) "Fundamentals of Heat and Mass Transfer" by F.P. Incropera, John Wiley (2007) Lecturers: Dr Farlan Veraitch (course co-ordinator), Prof Mike Hoare, Dr Dan Bracewell

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Course code: BENG G018 Title: Mammalian Cell Culture and Stem Cell Processing Value: 15 credits Year: MSc Aims: The aim of the module is to familiarise students with the current challenges in mammalian

cell culture and regenerative medicine bioprocessing. Students will be able to determine the information required to underpin the process of scaling both universal and patient specific cell therapies required for their routine deployment in the clinic.

Learning Outcomes: Following completion of the course, students will have an understanding of:

• Established routes for the development of productive cell lines • Large scale operation of mammalian cell cultures • Economic issues associated with mammalian cell processes and stem cell processes • Challenges associated with developing stem cell bioprocesses • Automation options for stem cell processes

Learning hours: 150 hours including 35 hours lectures, 10 hours case study, 40 hours reading, 60 hours group work and report preparation and 1 hour presentation. Coursework: Group case study reports and presentations Assessment: Coursework (100%). Synopsis: The course will cover the following topics:

• The underlying technology of mammalian cell process development • Managing the transition from producing early stage material for clinical trials to large-

scale manufacture. • Product related processing issues - particularly viruses, monoclonal antibodies and fusion

proteins • Media development • Economic evaluation of process development and the business challenges. • The impact of cell physiology and metabolic engineering on recombinant protein

productivity • Stem cells - Sourcing, characterisation and banking • Stem cell expansion and differentiation – The need for tightly controlled processes with

respect to quality assurance and regulatory compliance. • Automation of stem cell bioprocessing • Contract manufacture and stem cells • Ethics with respect to stem cell bioprocessing and commercialisation

Lecturers: Dr Farlan Veraitch and Prof. Chris Mason (course co-ordinators) Additional lectures given by industrial representatives: Suzanne Aldington – Lonza, Jon Dempsey – Invitrogen, Suzanne Gibson – MedImmune, Nick Hutchinson – Parker Hannifin Ltd, Colin Jaques – Lonza Biologics, Sakis Mantalaris - Imperial College London, Julia Markusen - Merck, Carol Marshall – GlaxoSmithKline, Ronan O’Kennedy – Newcastle University, Mark Smales - University of Kent, Julie Daniels - Moorfields Eye Hospital NHS Foundation Trust, Lucia D’Apote – EMEA, Rosemary Drake - The Automation Partnership, Charles Hunt - UK Stem Cell Bank, Paul Kemp - Intercytex, Kenny Pollock - ReNeuron plc, Mike Watts - UCL Hospital Wolfson Cellular Therapy Unit

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Course code: BENG GB01 Title: Metabolic Processes and Regulation Value: 15 units Year: MSc Aims: The objective of the course is to teach Biochemical engineering students the fundamentals

of Microbial Metabolism and Pathway Engineering in order to prepare them for biotechnology and biology based industries. The course requires a good understanding of biological sciences.

Learning Outcomes: Following completion of the course, students will have an understanding of:

• demonstrating an understanding of cellular metabolic processes • the key differences between prokaryotic and eukaryotic control regulation at the DNA,

RNA, protein and metabolic levels • the principles and application of metabolic engineering for improved bioprocesses.

Learning time: 150 hours including 45 hours lectures, 60 hours private reading, 15 hours seminars /

tutorials and 30 hours revision time. Synopsis: The course deals with the molecular biology of prokaryotes mainly with some reference to

mammalian and eukaryotic systems. It includes description of plasmids, microbial genetics, prokaryotic transcription and its control, protein synthesis, DNA replication, mutation and mutagenesis. Tutorial sessions link this knowledge to emerging pathway engineering concepts used to design better host cells for protein and small molecule production.

Assessment: Three unseen tests (45-60 minutes each) – 60% Three exercises – 40% Lecturers: Members of staff of the Department of Structural and Molecular Biology – Dr Giovanna

Santini (Course co-ordinator)

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Course code: BIOC G005* Title: General Biochemistry Value: 15 units Year: MSc Aims: To introduce students from a non-biological background to the ideas and techniques of

Cellular and Molecular Biology that are essential for a basic understanding of modern biology. To introduce students to the requirements of university study in the biological sciences and to encourage them to develop skills they will need to succeed in their studies.

By the end of this half course unit from lectures, computer simulations and animations and on-line tutorial exercises/course work students should have developed at the level of introductory university textbooks, knowledge and understanding of the main aspects of cellular biochemistry namely:

• An introduction to the cell and its structure and function • The fundamental units of biological structure, amino acids, monosaccharides and

nucleotides • The structure and function of cellular macromolecules, nucleic acids, proteins and

sugars • The process of DNA replication, transcription and translation of genetic information and

DNA repair • The central catabolic and anabolic pathways in metabolism • Use of web-based biological software tools • Interpretation of experimental results and numerical problems

Learning time: 150 hours including 30 hours of lectures, seminars and tutorials, 40 hours of optional

practical training and assessment and 60 hours of Test and Assessment preparation and 20 hours of Essay preparation.

This includes the time that students are expected to spend in understanding and revising the lecture materials and understanding and completing the tutorial work. It takes approximately 4-5 hours of revision per hour of lecture; this includes writing yourself a copy of detailed lecture notes from the annotations you made during the lectures themselves and reading about the lecture topic in textbooks and other authenticated sources of information. This is a different style of learning from what you may be familiar with and it is best to develop good study habits early on in your course.

Assessment: In-course Tests: 60% In course Assessments: 30% Essay: 10% Synopsis: The chemistry of biology, cell ultrastructure and function, introduction the key concepts of

molecular biology, biological macromolecules and assemblies with emphasis on protein and enzymes, metabolic processes

Lecturers: Dr. Snezana Djordjevic, Dr Andrea Townsend-Nicholson, Dr Chris Taylorson, Ms C Dawson *this course code is subject to change. MSc Tutors will inform students of any changes.

Learning Outcomes:

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Course code: BENG GB03 Applied Cell and Molecular Biology Value: 15 units Year: MSc Aims: As biologics and cell-based therapies become an increasingly important product class in the

pharmaceutical industry so the skill sets of process engineers must expand to suit. The ability to acquire manipulate human cells and manage DNA-based tools, conventionally restricted to product development, is now being applied to process development within a ‘whole bioprocess’ approach. This course will provide an understanding of the science and techniques of cell and molecular biology as they relate to development of cell-based platform technologies. Application themes include host cells for biopharmaceutical manufacturing (biosimilars, vaccines), cells as therapeutics within regenerative medicine and development of whole cell biocatalysts in industrial biotechnology.

Following completion of the course students will be able to: • utilise basic recombinant DNA techniques • communicate with life science specialists • apply the biology of yeast, mammalian and bacterial cells for industrial uses • understand the basic biology of human stem cells • relate molecular biology to challenges in biochemical engineering

Learning time: 144 hours including 24 hours of lectures, seminars and tutorials from process-focused life

scientists, 40 hours of practical training and assessment and 40 hours of coursework and examination preparation.

This includes the time that students are expected to spend in understanding and revising the

lecture materials and understanding and completing the tutorial work. It takes approximately 4-5 hours of revision per hour of lecture; this includes writing yourself a copy of detailed lecture notes from the annotations you made during the lectures themselves and reading about the lecture topic in textbooks and other authenticated sources of information. This is a different style of learning from what you may be familiar with and it is best to develop good study habits early on in your course.

Coursework: 1 individual laboratory report and 5 sets of practical assessments Assessment: One unseen written examination (2 hours) 70% Coursework 30% Synopsis: Stem cell biology, DNA structure, replication, central dogma, genetic code, transcription,

RNA structure, translation, tRNA and ribosome structure, nascent polypeptides, proteins, plasmids, chromosomes, genomes, cultivation of mammalian, yeast and bacterial cells, human cells as therapeutics, gene syntax in mammalian, yeast and bacterial cells, transfection of human cells, transformation of yeast and bacterial cells, DNA analytics

Laboratory reports:

• design of preparative PCR strategy ligating PCR fragment into mammalian expression plasmid

• bacterial transformation • diagnostic digest of resultant replicons Examination of knowledge and understanding of call and molecular biology themes and how they relate to biochemical engineering.

Lecturers: Process-focused life scientists Dr Darren Nesbeth and Dr Ivan Wall manage the course

Learning Outcomes:

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Course Code: BENG GD99 Title: Dissertation on Bioprocess Design Value: 60 Credits Year: MSc Aims: To prepare a dissertation embracing an accredited (chartered engineering status) design

study on a process for the production of biomaterials arising out of life science discoveries. Such biomaterials would typically include biopharmaceutical products arising out of phase II clinical trials and the dissertation will examine the four key stages to production:

Stage 1: The investigation of process specification at laboratory to pilot scale Stage 2: Whole bioprocess study Stage 3: The validation and implementation of quality control procedures Stage 4: The design project:

I. The creation and analysis of a bioprocess II. The design and economic appraisal of a bioprocess III. Safety audit of a bioprocess

Synopsis: Details for each of the four stages is listed below. Contact time: 600 hours Coursework: Stage 1: Written practical reports Stage 2: Laboratory book, oral presentation, practical performance Stage 3: Case study reports and Project report Stage 4: Written dissertation and poster Assessment: Stage 1: Written practical reports (12%) Stage 2: Oral presentation and coursework (8%), Stage 3: Course work (20%) Stage 4: design project report - dissertation (10000 words) (60%), Course co-ordinator: Dr Dan Bracewell, see stages for other co-ordinators. Stage 1: Investigation of Process Specification from Laboratory to Pilot Scale Aims: The aim of practical studies is to provide students exposure to some of the modern

experimental facilities and protocols in Biochemical Engineering. Through the hands-on sessions, the students will get experience with practical aspects of various modern techniques along with the underlying principles.

Learning time: 100 hours including 30 hours practical sessions and 70 hours report write-up Coursework: Written practical reports Assessment: Written practical reports (100%) Synopsis: The course consists of an investigation on process specification from laboratory to pilot

scale. The students will receive instruction on the appraisal of laboratory and pilot scale operations involved in bioprocess sequences and then seek to complete an original investigation into process scale performance for their target product. This will require a detailed experimental planning programme including predictions of mass and energy balances and of transport phenomena (e.g. heat transfer for removal of metabolic heat, mass transfer for oxygen supply). A dedicated series of individual experiments is used to enhance the delivery of this part of the course. • O2 transfer:

Students will investigate an experimental method for the determination of the volumetric mass transfer coefficient, KLa. They will first be introduced to the oxygen transfer mechanism and to the principles behind dissolved oxygen measurements in situ. They will then use a set of data to evaluate KLa under different conditions in a stirred tank reactor. The final step consists of the use of dimensional analysis to correlate experimentally-obtained data and develop an empirical equation linking KLa to process parameters.

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• Biotransformation: This practical provides students with hands-on experience in carrying out and monitor an immobilised enzyme catalysed biosynthetic reaction as used in biocatalytic processes. The students are required to consider theoretical aspects of classical enzyme kinetics, thermodynamic parameter calculations and their relevance to real biocatalytic processes. In addition students are required to consider how the reaction could be scaled up, including a suggestion of a suitable reactor design and the process benefits of using enzyme immobilisation. • Rheology: This practical focuses on the basic concepts of rheology and aims at enhancing the theory covered during the lectures. It consists of experimental measurements of the rheological properties of a Newtonian fluid using different types of viscometers. First students will derive shear stress, shear rate and viscosity using the experimental data obtained using a cup and bob viscometer. They will then use an impeller viscometer to generate power curves for three impeller types and will be able to link rheological properties to flow regime and equipment design. • Centrifugation: (2 practicals)

(a) Ultra scale-down predication of the industrial-scale centrifugal recovery of shear - sensitive biological materials

(b) Pilot scale verification of ultra scale-down predictions using continuous flow solid bowl and disc stack centrifuges. • Microfiltration: Students develop critical flux and transmission data for a range of membrane types (MF& UF) and seek to relate these performance metrics to established theory. By the use of different membrane geometrics students also learn about the impact of shear in cross flow operation and discuss the influence of cartridge lengths and diameter in long-term membrane performance. • Chromatography:

This practical introduces the principles of packed bed column packing and testing of axial dispersion • Homogenisation: The disruption of the cell wall to release ultracellular products is a key stage in many processes – Students become familiar with bend melting and high pressure homogenisation techniques. Protein release data is modelled by classical first order kinetics. The practical augments theoretical lecture material and also considers aspects of safe operation and containment of high pressure (1000 gar) units. • Sterilization and temperature Mapping:

This practical is concerned with prediction of the time-temperature profile for a batch sterilisation based on unsteady-state heat transfer in a stirred tank reactor. In addition it provides the students with a practical understanding of the set-up and operation of a bioreactor focussing on steam-in-place sterilisation and introduces software for on-line monitoring and control of fermentation process parameters. • Design of Experiments:

This practical introduces students to the principles of statistical Design of Experiments (DoE) including factorial and response surface designs. Students then undertake a case study showing how DoE can be applied to the optimisation of a microbial fermentation process. Design Expert 8, the industry standard software, is used to first statistically analyse and then model a real fermentation data set.

For each practical, a staff member is responsible for overseeing the practical and a team of

demonstrators and the head demonstrator will be recruited from departmental PhD/EngD students and trained in advance to lead the practical sessions. A handbook with all detailed descriptions of specific practical including objectives, experimental protocol, data analysis, safety and write-up guideline, and the instructions on timetable, grouping and report submission procedure are distributed on a briefing session before the practical starts. Experiments will be conducted in small groups under the trained demonstrators where students will follow experimental protocol designed in different areas. This team-based learning activity requires substantial management of the course.

Textbooks: Practicals Handbook Lecturers: Dr Yuhong Zhou (stage co-ordinator), 28 demonstrators, Dr Frank Baganz, Dr Nicolas Szita,

Dr Paul. Dalby, Dr Martina Micheletti, Dr Dan Bracewell, Prof. Nigel Titchener-Hooker, Prof Gary Lye, Prof. Mike Hoare, Prof. Eli Keshavarz-Moore.

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Stage 2: Whole Bioprocess Study Summary: The students will receive instruction on the appraisal of laboratory and pilot scale operations

involved in bioprocess sequences and then seek to complete an original investigation into process scale performance for their target product. This will require a detailed experimental planning programme including predictions of mass and energy balances and of transport phenomena (e.g. heat transfer for removal of metabolic heat, mass transfer for oxygen supply). A week long intensive pilot scale study will follow such investigations and will be concluded by an appraisal of process options. This will be the conclusion of the experimental work.

Aims: The purpose of the study is to get students involved with the department’s research activities

at pilot scale and allows them to become familiar with experiments planning, bioreactor and other downstream processing operations, analytical techniques. In addition they also engage with data analysis and results’ presentation activities. The study is a full time activity from Monday to Friday, typically from 9 am to 6pm, at the end of term 2. Students, grouped in teams of 5 or 6, will engage with the production of a wide range of products ranging from enzymes, small molecules, antibodies and virus-like particles. Some groups will also explore scale-up/down techniques. Each group is required to complete a Laboratory Book which should form a comprehensive record of the group’s. The book should have accurately recorded:

• Equipment used • Experimental plan followed • Data gathered (e.g. print outs from the computer logging the fermentation) • Further observations (such as visual inspections e.g. nature of the material post

centrifugation) • Problems and deviations from planned experimentation

Finally the groups present their findings in the form of an oral presentation on the Friday afternoon, an event to which the whole Department is invited.

Intended Learning Outcomes: Scientifically describe undertaken activities, materials and methods used and equipment; Understand the operation of bioprocessing lab and pilot scale equipment;

Analyse data, derive general correlations and compare with previously published literature;

Specify theoretical equations that appropriately describe the phenomena observed and test their validity under real process conditions using experimentally-obtained data (make links among different taught subjects using a real process example).

Preparation: A one-hour briefing takes place one week before the start of this activity where students are

told about the approach adopted (teamwork activity, working hours, assessment) and they are briefed on safety issues when working in pilot plant and laboratory areas. Once divided into groups, they have a chance to meet their supervisor (usually a PhD, EngD or post-doctoral researcher) who gives them a short outline of the project. A handbook containing all relevant practical information, a detailed description of each project’s activities and group presentation’s notes is distributed to the students.

Assessment: The following elements are accounted for: Project supervisor’s assessment of performance during the activities (33%).

Oral presentation assessment by the course coordinator (33%) Assessment of Laboratory Book (33%)

Lecturers: Dr Dan Bracewell (stage co-ordinator) plus departmental technical and academic staff and research team.

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Stage 3: The Validation and Implementation of Quality Control Procedures Aims: The course addresses the challenge of the safe delivery to patients of biopharmaceuticals

and in particular injectables. The aim of the course is to familiarise students with current validation methodology using leading edge developments with expert speakers in a workshop format. Students will be able to determine the information required to validate a process across the industry.

Learning Outcomes: Following completion of the course, students will have an understanding of:

• Assessing new process concepts and judge key issues to be addressed before regulatory acceptability for Manufacture will be achievable (i.e. address codes of practical relating to SHE issues).

• how to determine the information required and validate a process and the resource requested to manage the implementation of stage leading to full validated status.

• how to communicate with validation specialists • what is required by the regulatory authorities for compliance including future direction of

the regulations • the implications of validation for process development • current validation practice across the bioprocess industry • oral and written presentation skills on issues of validation including a validation master plan.

Learning time: 150 hours including 12 hours industrial expert lectures, 50 hours seminars and

presentations, 30 hours project advice and 50 hours coursework preparation. Coursework: 1 individual validation master plan and three prepared oral presentations. Assessment: Case study reports 45% Project report 55% Synopsis: Regulations (FDA and EMEA) to meet product safety for biologics; analytical methods to

support process validation; fermentor and control system validation; validation of recovery and purification operations; cleaning, sterilisation and turnaround systems; operation and control of multiproduct plants; change control in the event of process failures /planned enhancements.

Case study reports assessed as pre-prepared oral presentations on: • appraisal of multiproduct facilities and change control • validation of process change – scale up and scale out • disposable versus conventional equipment – validation appraisal

Project report assessed as a validation master plan on the analysis of process change and revalidation strategy

Prerequisites: Courses in downstream processing and bioreactor engineering where these operations form the main basis for validation discussions.

Source reference material:

• Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2002 (The Orange Guide) Published by The Stationery Office, PO Box 29, Norwich, NR3 1GN

• Homepage: www.fda.gov – provides on-line access to FDA information, guidelines and rules from both CBER and CDER. (US Food and Drug Administration – FDA).

• Homepage: www.emea.eu.int/ - Also try Eudranet at www.eudra.org – this is the EU pharmaceutical regulatory internet homepage. (European Medicines Evaluation Agency – EMEA).

• Homepage: http://www.ifpma.org – this includes pages on the International Conference on Harmonisation (ICH) and International Federation of Pharmaceutical Manufacturers Associations (IFPMA).

• Homepage: www.pda.org – provides information on sterile products manufacturing. Parenteral Drug Association (PDA)

Lecturers: Prof Mike Hoare (stage co-ordinator) plus experts in validation from the biopharmaceutical

industry including Tim Hughes, CSL Ltd; Paul Bird, Merck Sharpe & Dhome; Tim Clayton, Merck Serono; Louise Ingram, Lonza Biologics plc; Ingrid Maes, PriceWaterhouseCoopers; Graham McCartney & Deirdre Ryan, Eli Lilly; Matt Osborne, Eli Lilly; Gael Peron & Arnaud Schmutz, Sartorius-Stedim; Richard Francis, BTG plc; Angus Thompson, Merck Sharp &

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Dhome; Ron Wheeler & Mike Beatrice (ex-FDA), Abbot Laboratories; John Woodgate & Brett Littlefield, Pall Life Sciences

Stage 4: The Design Project Summary: The bioprocess design studies will be pursued by groups of students working as teams with

each member preparing a complete design dissertation comprising an individual report on the whole team studies, and an individual report on his/her own findings. In addition to a written dissertation, assessment will be via oral presentations, poster presentation and viva.

Aims: i) The creation and analysis of a bioprocess. In this first part of the accredited design study

students will be presented with a novel life science target with a guide to desired production scale and key literature indicating the market potential (e.g. clinical efficiency and patient scope). They will receive instruction on evaluation of the scientific background and intellectual property and prepare a literature appraisal report as the foundation to the design stages. Students will then define the process based on pilot plant experimental data and observations and on literature appraisal. The output will be completed mass and energy balances across the total process and an appraisal of equipment size/scale. A detailed description of flow (flowsheet plus report) and process recommendation report will be the key outputs.

ii) Design and economic appraisal. This section will develop abilities in fast evaluation and

analysis of bioprocess design problems. It will include aspects of project scheduling and management as well as economic appraisal and take students from the specification of equipment through the stage of reconciling equipment needs with layouts and then to the scheduling and management of projects in a dynamic environment. Each team will prepare a complete design report covering the user specification for a key item of equipment; process and mechanical design with appropriate mechanical drawing; piping and instrumentation and specification of control; preparation and analysis of plant layouts; personnel and material flows; analysis of safety (HAZOP study) including biosafety and containment appraisal; analysis of environmental impact; economic appraisal and sensitivity analysis; project schedule including analysis of management and change. This section will be assessed in the form of a design report, a mechanical drawing and a process/plant layout drawing.

iii) Safety audit of a bioprocess

The dissertation will conclude with future studies, recommendation and executive summary followed by poster presentation and viva on the whole dissertation.

Textbooks: “Chemical Engineering Design” by Towler and Sinnott (5th Edition), Butterworth – Heineman (2009). “Industrial Bioseparations: Principles and Practise” by Daniel Fortiniti, Blackwell (2008). “Principles of Bioseparations Engineering” by Raja Ghosh, World Scientific (2006). Lecturers: Dan Bracewell and Tarit Mukhopadhyay (stage co-ordinators) plus experts in design from the

biopharmaceutical industry including Chris Davis, Jacobs Engineering, Claire Hill, Biopharm Services, Andy Hooker, Syntaxin, Angela Osborne, eXmoor Pharma concepts James Savery, Biopharm Services Vaughan Thomas, SciTech Engineering Ltd, Gordon Farquharson, Consultant. Nigel Fletcher, Foster Wheeler, Bjorn Hammarberg, ABD Life Sciences, Thorsten Kimmel, Pharmadule, Gráinne McDonagh, Biopharm Services, Andrew Provan, eXmoor Pharma Concepts, Roy Okec, Biopharm Services, Paul Sankey, Health & Safety Executive.

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Course Code: BENG GR99 Title: Dissertation on Bioprocess Research Value: 60 Credits Year: MSc Aims: To prepare a dissertation embracing an accredited (chartered engineering status) on a

research study on a novel bioprocess development for the production of biomaterials arising out of life science discoveries. The dissertation will examine the four key stages to address bioprocessing challenge:

Stage 1: investigation of process specification at laboratory to pilot scale, Stage 2: whole bioprocess study, Stage 3: validation and implementation of quality control procedures Stage 4: research project. Learning time: 600 hours Synopsis: Details for each of the four stages is listed below. Coursework: Stage 1: Written practical reports Stage 2: Laboratory book, oral presentation, practical performance Stage 3: Case study reports and Project report Stage 4: Written dissertation and poster Assessment: Stage 1: Written practical reports (12%) Stage 2: Oral presentation and coursework (8%), Stage 3: Course work (20%) Stage 4: Research project report - dissertation (10000 words) (60%), Course co-ordinator: Dr Yuhong Zhou (see stages for other contributors) Stage 1: Investigation of process specification from laboratory to pilot plant scale Aims: The aim of practical studies is to provide students exposure to some of the modern

experimental facilities and protocols in Biochemical Engineering. Through the hand-on sessions, the students will get experience with practical aspects of various modern techniques along with the underlying principles.

Learning Outcomes: By completion, the students are able to establish an extensive knowledge of a wide range of

biochemical engineering processes and equipment at small scale and large scale, use planned experiments to solve biochemical engineering problems, appreciate high standard of Safety, Health and Environment in operations of laboratories and pilot plant, analyse experimental data to assess bioprocess performance.

Learning time: 100 hours including 30 hours practical sessions and 70 hours report write-up Coursework: Written practical reports Assessment: Written practical reports (100%) Synopsis: The course consists of an investigation on process specification from laboratory to pilot

scale. The students will receive instruction on the appraisal of laboratory and pilot scale operations involved in bioprocess sequences and then seek to complete an original investigation into process scale performance for their target product. This will require a detailed experimental planning programme including predictions of mass and energy balances and of transport phenomena (e.g. heat transfer for removal of metabolic heat, mass transfer for oxygen supply). A dedicated series of individual experiments is used to enhance the delivery of this part of the course. • O2 transfer: Students will investigate an experimental method for the determination of the volumetric mass transfer coefficient, KLa. They will first be introduced to the oxygen transfer mechanism and to the principles behind dissolved oxygen measurements in situ. They will then use a set of data to evaluate KLa under different conditions in a stirred tank reactor. The final step consists of the use of dimensional analysis to correlate experimentally-obtained data and develop an empirical equation linking KLa to process parameters.

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• Biotransformation: This practical provides students with hands-on experience in carrying out and monitor an immobilised enzyme catalysed biosynthetic reaction as used in biocatalytic processes. The students are required to consider theoretical aspects of classical enzyme kinetics, thermodynamic parameter calculations and their relevance to real biocatalytic processes. In addition students are required to consider how the reaction could be scaled up, including a suggestion of a suitable reactor design and the process benefits of using enzyme immobilisation. • Rheology: This practical focuses on the basic concepts of rheology and aims at enhancing the theory covered during the lectures. It consists of experimental measurements of the rheological properties of a Newtonian fluid using different types of viscometers. First students will derive shear stress, shear rate and viscosity using the experimental data obtained using a cup and bob viscometer. They will then use an impeller viscometer to generate power curves for three impeller types and will be able to link rheological properties to flow regime and equipment design. • Centrifugation: (2 Practicals) (a) Ultra scale-down predication of the industrial-scale centrifugal recovery of shear -

sensitive biological materials (b) Pilot scale verification of ultra scale-down predictions using continuous flow solid bowl

and disc stack centrifuges. • Microfiltration: Students develop critical flux and transmission data for a range of membrane types (MF& UF) and seek to relate these performance metrics to established theory. By the use of different membrane geometrics students also learn about the impact of shear in cross flow operation and discuss the influence of cartridge lengths and diameter in long-term membrane performance • Chromatography:

This practical introduces the principles of packed bed column packing and testing of axial dispersion • Homogenisation: The disruption of the cell wall to release ultracellular products is a key stage in many processes – Students become familiar with bend melting and high pressure homogenisation techniques. Protein release data is modelled by classical first order kinetics. The practical augments theoretical lecture material and also considers aspects of safe operation and containment of high pressure (1000 gar) units. • Temperature Mapping: This practical is concerned with prediction of the time-temperature profile for a batch sterilisation based on unsteady-state heat transfer in a stirred tank reactor. In addition it provides the students with a practical understanding of the set-up and operation of a bioreactor focussing on steam-in-place sterilisation and introduces software for on-line monitoring and control of fermentation process parameters. • Design of Experiments: This practical introduces students to the principles of statistical Design of Experiments (DoE) including factorial and response surface designs. Students then undertake a case study showing how DoE can be applied to the optimisation of a microbial fermentation process. Design Expert 8, the industry standard software, is used to first statistically analyse and then model a real fermentation data set. For each practical, a staff member is responsible for overseeing the practical and a team of demonstrators and the head demonstrator will be recruited from departmental PhD / EngD students and trained in advance to lead the practical sessions. A handbook with all detailed descriptions of specific practical including objectives, experimental protocol, data analysis, safety and write-up guideline, and the instructions on timetable, grouping and report submission procedure are distributed on a briefing session before the practical starts. Experiments will be conducted in small groups under the trained demonstrators where students will follow experimental protocol designed in different areas. This team-based learning activity requires substantial management of the course.

Textbooks: Practical Handbook Lecturers: Dr Yuhong Zhou (stage co-ordinator), 28 demonstrators, Dr Frank. Baganz, Dr Nicolas

Szita, Dr Paul Dalby, Dr Martina Micheletti, Dr Dan Bracewell, Prof. Nigel Titchener-Hooker, Prof Gary Lye, Prof. Mike Hoare, Prof. Eli Keshavarz-Moore.

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Stage 2: Whole Bioprocess Study Summary: The students will receive instruction on the appraisal of laboratory and pilot scale operations

involved in bioprocess sequences and then seek to complete an original investigation into process scale performance for their target product. This will require a detailed experimental planning programme including predictions of mass and energy balances and of transport phenomena (e.g. heat transfer for removal of metabolic heat, mass transfer for oxygen supply). A week long intensive pilot scale study will follow such investigations and will be concluded by an appraisal of process options. This will be the conclusion of the experimental work.

Aims: The purpose of the study is to get students involved with the department’s research activities

at pilot scale and allows them to become familiar with experiments planning, bioreactor and other downstream processing operations, analytical techniques. In addition they also engage with data analysis and results’ presentation activities. The study is a full time activity from Monday to Friday, typically from 9 am to 6pm, at the end of term 2. Students, grouped in teams of 5 or 6, will engage with the production of a wide range of products ranging from enzymes, small molecules, antibodies and virus-like particles. Some groups will also explore scale-up/down techniques. Each group is required to complete a Laboratory Book which should form a comprehensive record of the group’s. The book should have accurately recorded:

Equipment used Experimental plan followed

Data gathered (e.g. print outs from the computer logging the fermentation) Further observations (such as visual inspections e.g. nature of the material post

centrifugation) Problems and deviations from planned experimentation

Finally the groups present their findings in the form of an oral presentation on the Friday afternoon, an event to which the whole Department is invited.

Learning outcomes: Following completion of the course, students will have an understanding of:

• how to scientifically describe undertaken activities, materials and methods used and equipment;

• the operation of bioprocessing lab and pilot scale equipment; • Analysing data, derive general correlations and compare with previously • published literature; • Specifying theoretical equations that appropriately describe the phenomena

observed and test their validity under real process conditions using experimentally-obtained data (make links among different taught subjects using a real process example).

Preparation: A one-hour briefing takes place one week before the start of this activity where students are

told about the approach adopted (teamwork activity, working hours, assessment) and they are briefed on safety issues when working in pilot plant and laboratory areas. Once divided into groups, they have a chance to meet their supervisor (usually a PhD, EngD or post-doctoral researcher) who gives them a short outline of the project. A handbook containing all relevant practical information, a detailed description of each project’s activities and group presentation’s notes is distributed to the students.

Assessment: The following elements are accounted for: Project supervisor’s assessment of performance during the activities (33%). Oral presentation assessment by the course coordinator (33%) Assessment of Laboratory Book (33%) Lecturers: Dr Dan Bracewell (stage co-ordinator) plus departmental technical and academic staff and

research team.

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Stage 3: Bioprocess Validation and Quality Control Aims: The course addresses the challenge of the safe delivery to patients of biopharmaceuticals

and in particular injectables. The aim of the course is to familiarise students with current validation methodology using leading edge developments with expert speakers in a workshop format. Students will be able to determine the information required to validate a process across the industry.

Learning Outcomes: Following completion of the course, students will have an understanding of:

• how to assess new process concepts and judge key issues to be addressed before regulatory acceptability for Manufacture will be achievable (i.e. address codes of practical relating to SHE issues),

• how to determine the information required and validate a process and the resource requested to manage the implementation of stage leading to full validated status,

• how to communicate with validation specialists, • what is required by the regulatory authorities for compliance including future direction of

the regulations, • the implications of validation for process development, • current validation practice across the bioprocess industry, • oral and written presentation skills on issues of validation including a validation master plan.

Learning time: 150 hours including 12 hours industrial expert lectures, 50 hours seminars and presentations, 30 hours project advice and 50 hours coursework preparation Coursework: 1 individual validation master plan and three prepared oral presentations Assessment: Case study reports 45% Project report 55% Synopsis: Regulations (FDA and EMEA) to meet product safety for biologics; analytical methods to

support process validation; fermentor and control system validation; validation of recovery and purification operations; cleaning, sterilisation and turnaround systems; operation and control of multiproduct plants; change control in the event of process failures /planned enhancements.

Case study reports assessed as pre-prepared oral presentations on: • appraisal of multiproduct facilities and change control • validation of process change – scale up and scale out • disposable versus conventional equipment – validation appraisal

Project report assessed as a validation master plan on the analysis of process change and revalidation strategy

Prerequisites: Courses in downstream processing and bioreactor engineering where these operations form

the main basis for validation discussions. Source reference material:

• Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2002 (The Orange Guide) Published by The Stationery Office, PO Box 29, Norwich, NR3 1GN

• Homepage: www.fda.gov – provides on-line access to FDA information, guidelines and rules from both CBER and CDER. (US Food and Drug Administration – FDA)

• Homepage: www.emea.eu.int/ - Also try Eudranet at www.eudra.org – this is the EU pharmaceutical regulatory internet homepage. (European Medicines Evaluation Agency – EMEA)

• Homepage: http://www.ifpma.org – this includes pages on the International Conference on Harmonisation (ICH) and International Federation of Pharmaceutical Manufacturers Associations (IFPMA)

• Homepage: www.pda.org – provides information on sterile products manufacturing. Parenteral Drug Association (PDA)

Lecturers: Prof Mike Hoare plus experts in validation from the biopharmaceutical industry including Tim

Hughes, CSL Ltd; Paul Bird, Merck Sharpe & Dhome; Tim Clayton, Merck Serono; Louise Ingram, Lonza Biologics plc; Ingrid Maes, PriceWaterhouseCoopers; Graham McCartney & Deirdre Ryan, Eli Lilly; Matt Osborne, Eli Lilly; Gael Peron & Arnaud Schmutz, Sartorius-Stedim; Richard Francis, BTG plc; Angus Thompson, Merck Sharp & Dhome; Ron Wheeler

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& Mike Beatrice (ex-FDA), Abbot Laboratories; John Woodgate & Brett Littlefield, Pall Life Sciences.

Stage 4: Bioprocess Research Project Aims: The course is designed to develop student’s research skills and research methods through

addressing the bioprocessing challenge in the production of biological therapeutics arising out of life science discoveries, from identifying, planning and executing a research project in biochemical engineering. After completion of the course, the students will have acquired a range of research skills.

Learning Outcomes: Following completion of the course, students will have an understanding of: • the aim of the project and its significance • Carrying out a critical literature review in the area of the research • Developing research methodology to investigate underlying problem • Devising experimental plan and conduct experiments to solve a relevant bioprocessing

problem • Analysing the data and draw conclusions • Developing advanced communication skills through presenting their research findings

and formulating a dissertation

Learning time: 500 hours including 12 weeks full time research project write-up and 20 hours research planning meetings and 4 hours poster presentation/viva

Coursework: Written dissertation, written practical reports poster presentation and oral presentation Assessment: Written dissertation (10,000 words) (60%)

Oral presentation (20%) Coursework (20%) Synopsis: The bioprocess research studies will be pursued by individual students to develop the

research skills necessary for the understanding of the issues involved in whole bioprocessing. It will provide the underlying training in conducting a literature survey of the state-of-the-art in experimental design, in experimental planning against self-set milestones, preparation of research budgets and in the collection of data and their statistical and theoretical analysis.

Research topics will be linked in with the state-of-the-art research facilities and research areas being carried out in the department and connected to the bioprocess of interest. The students will be assigned a supervisor to manage the project. This section of the dissertation will be presented via a full report, proformas, and the poster.

Textbooks: None Lecturers: Dr Yuhong Zhou (stage co-ordinator) Staff in Biochemical Engineering and the supervisors

of research projects

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Appendix 3 DEPARTMENT OF BIOCHEMICAL ENGINEERING UNIVERSITY COLLEGE LONDON RECOMMENDED TEXT BOOKS FOR ACADEMIC YEAR 2011/2012

Author(s) Title Publisher & Date

Course Unit(s)

Library Location* (& Copies)

Comments

Akker van den HEA

Bioprocess Technology: Modelling and Transport Phenomena

Butterworth Heinmann 1992

ALL ENG QQ 5 BIO (4)

Part of the BIOTOL self learning series. Many worked examples.

Asenjo J & Merchuk J

Bioreactor System Design

Marcel Dekker 1994

BENG 4002, BENG 2010

ENG QQ 5 ASE (5)

Reference book with chapters on different types of reactor design.

Asenjo J Separation Processes in Biotechnology

Marcel Dekker 1990

BENG1004 ENG Q86 ASE (1)

Useful for downstream aspects, dated in certain areas

Atkinson B & Mavituna F

Biochemical Engineering and Biotechnology Handbook

MacMillan 2nd Ed 1991

ALL SLC (1) Essential reference work especially for design.

Attenborough M

Engineering Mathematics Exposed

McGraw-Hill 1994

ENG A 30 ATT (3)

An excellent text but gets quite advanced at end of chapters.

Bailey JE & Ollis DF

Biochemical Engineering Fundamentals

McGraw-Hill 2nd Ed 1986

ALL ENG QQ 5 BAI SLC (13)

Original text in the field. Global approach but lacks specifics.

Bes J et al

Operational Modes of Bioreactors

Butterworth Heinmann 1992

BENG 4002, BENG 2010

ENG QQ 5 OPE (2)

Part of the BIOTOL self learning series. Many worked examples.

Blanch HW & Clark DS

Biochemical Engineering

Marcel Dekker 1997

ALL ENG QQ 5 BLA (5)

Useful text with a mathematical treatment of many key areas of the course.

Butler M Animal Cell Culture Technology: The Basics 2nd Ed.

2004 BENG 4002, BENG 2010

ENG QQ 80 BUT (4)

Good introduction to animal cell culture technology.

Cabral JMS et al

Applied Biocatalysis Harwood Academic 1993

BENG 3008 ENG QQ 80 CAB SLC (4)

Useful text with plenty of examples covering both technical and engineering aspects.

Doran PM

Bioprocess Engineering Principles

Academic Press 1995

BENG 4002, BENG 2010, BENG 1004 BENG2001 BENG2011 BENG4001

ENG QQ 5 DOR (8)

Good worked examples. Weak on downstream processing area.

Faber K Biotransformations in Organic Chemistry

Springer Verlag 4th Ed. 2000

BENG 3008 ENG QQ 5 FAB (3)

Overview of biotransformation reactions.

Felder RM & Rousseau RW

Elementary Principles of Chemical Processes

Wiley & Sons 3rd Ed 2000

ALL ENG Q 5 FEL SLC (12)

Covers basic process analysis and transport phenomena very nicely.

Jenkins Product Recovery in Butterworth BENG2001 ENG Part of the BIOTOL self

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RO

Bioprocess Technology

Heinmann 1992

BENG2011 BENG 4001

QQ 5 PRO (3)

learning series. Many worked examples.

Kingsman SM & Kingsman AJ

Genetic Engineering

Blackwell Scientific 1988

BENG3012 BIOLOGY H 5 KIN (4)

Introduction to genetic manipulations in eukaryotes.

Lehninger AL

Principles of Biochemistry

Worth Publishing 3rd Ed 2000

BIOC 1003, BIOC 2007, BENG3012

MED SCI G 5 LEH SLC (40)

A comprehensive reference text.

Mann J Secondary Metabolism

Clarendon Press 2nd Ed. 1987

BIOC 2007 MED SCI GN 5 MAN (3)

Dated but useful review of metabolic pathways to main groups of secondary metabolites.

Mijnbeek Getal

Bioreactor Design and Product Yield

Butterworth Heinmann Ltd 1992

BENG 4002, BENG 2010

ENG QQ 5 BIO (4)

Part of the BIOTOL self learning series. Many worked examples.

Nielsen J & Villadsen J

Bioreaction Engineering Principles

Plenum Press 2nd Ed. 2003

BENG 4002, BENG 2010

ENG QQ 5 NIE (6)

High quality but rather mathematical. Only book to cover metabolic flux analysis.

Pons M-N

Bioprocess Monitoring and Control

Hanser Press 1995

BENG 4002, BENG 2010

ENG QQ5 Reference book for this area of bioprocessing technology.

Riet K van’t & Tramper J

Basic Bioreactor Design

Marcel Dekker 1991

BENG 4002, BENG 2010

ENG QQ 5 RIE (6)

Covers design and operation of standard reactor configurations.

Shuler ML & Kargi F

Bioprocess Engineering: Basic Concepts

Prentice Hall 2nd Ed. 2002

BENG 4002, BENG 2010

ENG QQ 5 SHU (5)

Pitched at a reasonable level.

Stanbury P, Whitaker A & Hall SJ

Principles of Fermentation Technology

Pergamon Press 2nd Ed 1995

BENG 4002, BENG 2010, BENG 1004

ENG QQ 40 STA (8)

Readable coverage of basic fermentation technology.

Stanier RY

General Microbiology

Macmillan Press 5th Ed 1987

BIOC 1003, BENG3012

BIOLOGY C 5 STA (6)

A comprehensive reference text.

Alberts Betal

Molecular Biology of the Cell.

Taylor & Francis Inc. 5th Ed. 2008

BENGM012 MED SCI D 5 ALB

A leading cell biology textbook.

* Where multiple editions exist only the latest version is reported; SLC stands for Short Loan Collection. Online reference books See http://www.ucl.ac.uk/library/ebooks/ Flickinger M Encyclopaedia of Bioprocess Technology Vogel HC & Torado CL Fermentation & Biochemical Engineering Handbook

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Suggested Books for Purchase

Listed below are the key biochemical engineering textbooks you might wish to buy. These were chosen on the basis of cost and that they would be useful throughout the whole of your studies at UCL.

Bailey JE & Ollis DF, 2nd Ed. Biochemical Engineering Fundamentals ~ £45

Doran PM Bioprocess Engineering Principles ~ £45

Stanbury P, Whitaker A & Hall SJ, 2nd Ed. Principles of Fermentation Technology ~ £40

Felder RM & Rousseau RW, 3rd Ed. Elementary Principles of Chemical Processes ~ £40

Stroud KA 6th Ed. Engineering Mathematics ~ £35 For reference books related to the background sciences you might also consider purchasing the following:

Alberts B. Molecular Biology of the Cell ~ £50

Stanier RY 5th Ed. General Microbiology ~ £30

Stryer L 6th Ed. Biochemistry ~ £50

Streitwieser A 4th Ed. Introduction to Organic Chemistry ~ £30

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APPENDIX 4

COURSEWORK COVER SHEETS

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DEPARTMENT OF BIOCHEMICAL ENGINEERING

COVER SHEET

STUDENT’S NAME

COURSE NAME AND CODE

COURSE WORK TITLE

LECTURER’S NAME

PERSONAL TUTOR’S NAME

By submitting this course work, you affirm it is the product of your effort alone and meets all College and Department regulations regarding student conduct, especially those regarding plagiarism and self plagiarism. Wherever published, unpublished, printed, electronic or other information sources have been used as a contribution or component of this work, these are explicitly, clearly and individually acknowledged by appropriate use of quotation marks, citations, references and statements in the text. STUDENT’S SIGNATURE

DATE AND TIME SUBMIT. (FOR DEPARTMENTAL OFFICE USE ONLY)

IN OUT

Staple a completed and signed copy of this form to every piece of assessed coursework you submit for courses in the Department of Biochemical Engineering. Please firmly staple your work together. Unless otherwise stated by the lecturer concerned, please avoid the use of document containers such as plastic or cardboard covers, document wallets, ring binders or folders. No course work will be accepted without a signed submission sheet.

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DEPARTMENT OF BIOCHEMICAL ENGINEERING

Department of Biochemical Engineering

FORMAL REQUEST FOR EXTENSION

SURNAME

FIRST NAME

COURSE CODE & TITLE

COURSE TUTOR

DEADLINE FOR SUBMISSION

PROPOSED SUBMISSION DATE

REASON FOR EXTENSION REQUEST Student’s signature Date Documentation (tick as appropriate) □ Attached □ Given to Personal Tutor □ Given to Undergraduate Tutor

(Staff use only) EXTENSION REQUEST GRANTED: YES NO NEW DUE DATE: SIGNATURE STUDENT NOTIFIED: YES NO

1. Requests for extensions ARE NOT granted automatically. DO NOT assume an extension is granted upon submission of this document.

2. Extensions will be granted only under exceptional circumstances, not if the delay was avoidable (poor planning etc).

3. To maintain confidentiality, doctor’s notes/letters may be delivered to your Personal Tutor or the UG Tutor. The document should state the nature of the problem and the length of time you were/are considered unfit to work for.

4. If no extension is granted, late coursework will be penalised. 5. Requests for extension must be submitted to the Course Tutor IN ADVANCE of the deadline

for submission. Any requests for a further extension must be made to the Undergraduate Tutor in writing and must be accompanied by verifiable documentation.

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UCL BIOCHEMICAL ENGINEERING Coursework Template For Group Work Submission

GROUP WORK

Course code and title: Date submitted: Coursework number: Student’s Group: Set by:

We, the undersigned, confirm that this work is entirely that of our own, unless otherwise indicated and, where indicated, we have provided full reference citations as to the origin of the material used. We also confirm that we have read the departmental guidelines on plagiarism below and that we are aware of UCL’s policy on plagiarism. ___________________________ __________________________ ____________ Name (IN CAPITAL LETTERS) Signature Personal Tutor ___________________________ __________________________ ___________ Name (IN CAPITAL LETTERS) Signature Personal Tutor ___________________________ __________________________ ____________ Name (IN CAPITAL LETTERS) Signature Personal Tutor ___________________________ __________________________ ____________ Name (IN CAPITAL LETTERS) Signature Personal Tutor ___________________________ __________________________ ____________ Name (IN CAPITAL LETTERS) Signature Personal Tutor

PLAGIARISM

All work submitted as part of the requirements for any examination (including coursework) of the University of London must be expressed in your own words and incorporate your own ideas and judgements.

Plagiarism - that is the presentation of another person's thoughts or words as though they were your own - must be avoided, with particular care in course-work, essays and reports written in your own time. Direct quotations from the published or unpublished work of others must always be clearly identified as such by being placed inside quotation marks, and a full reference to their source must be provided in the proper form. Equally, if you summarise another person's ideas or judgements, you must refer to that person in your text, and include the work referred to in your bibliography.

Except for designated group work, syndicated coursework is not acceptable as UCL awards degrees to individuals and not to groups. We therefore require that coursework submitted by an individual to be that of the individual alone. You may discuss coursework with your friends and colleagues before you attempt it. This is part of the learning process. But you should complete it by yourself, not as part of a group or with a friend. The coursework you submit should be yours and yours alone.

PLAGIARISED, COPIED OR SYNDICATED COURSEWORK WILL NOT BE ACCEPTED. The College and University have strict penalties for those found guilty of plagiarism and other forms of copying, for example, exclusion from all further examinations of the College and/or the University.

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DEPARTMENT OF BIOCHEMICAL ENGINEERING

NOTIFICATION OF SPECIAL CIRCUMSTANCES

This form is to enable Personal Tutors to take into consideration any special circumstances that you believe may have affected your work. When it’s complete hand this and other relevant documentation to your Personal Tutor. Retain a copy of all documentation.

NAME (block capitals) _____________________________________ YEAR_____________ DEPARTMENT ____________________________________________________________ CONTACT (phone, email) _____________________________________________________ COURSES TO WHICH THE SPECIAL CIRCUMSTANCES APPLY: ____________________________________________________________/ALL□ (tick if applies)

MEDICAL CIRCUMSTANCES: (To be filled in by medical practitioner) Please provide the dates when the circumstances started and when the student was / will be fit to return to study. Please describe any consequences of the illness and/or treatment that may be relevant. Use your judgement to characterise the level of disruption to the student’s programme of study. SERIOUS □ MINOR □ ACUTE □ CHRONIC □ Use separate sheet if necessary. Signature: Date: Official Practitioner’s Stamp (or provide a medical certificate)

67

DEPARTMENT OF BIOCHEMICAL ENGINEERING

NOTIFICATION OF SPECIAL CIRCUMSTANCES

NON-MEDICAL CIRCUMSTANCES: (To be completed by the applicant) Give a brief description of the circumstances, accompanied by supporting documentation. Give the dates you were affected; an explanation of how the situation affected your study; and what you have done about it. Have you already had consideration/extensions? What consideration are you requesting? Use separate sheet if necessary. Signature: Date:

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DEPARTMENT OF BIOCHEMICAL ENGINEERING

NOTIFICATION OF SPECIAL CIRCUMSTANCES

Notes for guidance

What service does this form provide? Use this form for declaring any circumstances you believe may have adversely affected your performance during the degree programme. Do not use this form for requesting extensions to deadlines from acute, short term circumstances (Formal Request for Extension Form). Circumstances cannot be mediated more than once. What is a “special circumstance”? Personal Tutors will consider all factors which may affect a student’s performance as relevant factors for special consideration. These may include long term illness (physical or mental), bereavement, eviction from lodgings, welfare issues etc. The circumstances are not necessarily medical, but they are extraordinary. “Special circumstances” do not include poor planning or a lack of preparation on your part. What is the procedure? Complete the Notification of Special Circumstances Form and submit it along with your supporting documentation to your Personal Tutor, who will discuss your circumstances with the Undergraduate Tutor. What kind of supporting documentation will be needed? A medical certificate, verifiable letter from your doctor or completed and stamped Section …. For non-medical conditions, any relevant documentation and, in some circumstances, a letter of explanation from yourself or a third party may be considered. When should I submit the form? Students should keep Personal Tutors informed and document special circumstances as they arise. Your Personal Tutor will accept an application from you at any time during the teaching year, but not less than one week of the end of an examination period in question.

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APPENDIX 5 BBSRC Masters Training Grant (MTG) Form for MScs

Student Personal Details are required to be entered on JeS (Research Council Web-site) within 30 days of student commencement. Student Name Title Gender

Date Of Birth: Disabled: Yes/No Ethnic Origin: Nationality:

Study Start Date Expected End Date Actual End Date

Lead University

Organisation / Department Supervisor Title / Initials / Surname Start Date / End Date

Joint Supervisor

Organisation / Department Supervisor Title / Initials / Surname Start Date / End Date

1 Student Background Details

UNDERGRADUATE DETAILS

ORGANISATION DEGREE CLASS

Degree Subject Degree type

Degree Start Date Degree end date

POSTGRADUATE DETAILS

ORGANISATION DEGREE TYPE

Degree Subject

Year Awarded

OTHER RELEVANT WORKING EXPERIENCE

NAME OF COMPANY NO. OF YEARS

Position Nature of work

Name of Company No. of Years

Position Nature of work

Name of Company No. of Years

Position Nature of work

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OTHER INFORMATION

(To be filled in by JeS Administrator)

UNIQUE STUDENT NUMBER (HUSID) INCIDENCE NUMBER

(NUMHUS)

Academic session on commencement: First / Second / Third Term

2 Student Funding Details Fully funded (UK) No Stipend (EU) Full Time Student Part Time Student Annual stipend paid to student: Annual stipend paid from Industry: Annual stipend paid from CTA: Total Funding for EngD studentship: Annual Fees to be Paid by CTA: £ Grant Code

Disabled Student Allowance must be applied for within 3 months of

commencement of project

Overseas Fieldwork Expenses

must be applied for within 3 months of commencement of project

3 Contact and tracking students House number/Name

Street District/Area Town/City County Country Postcode Telephone Email (not UCL one) Fax Mobile

4 Project Details (if applicable)

TITLE

Abstract

Research Topic

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5 Collaboration Details (if applicable) Yes No Does this student Have a collaborating Company

Organisation Organisation Name Organisation Address Street District/Area Town/City County Country Postcode

Industrial Supervisor Contact Details Title Forenames Surname Telephone Email Additional Information Formal agreement signed

Yes

No

Value of contribution

All MScs are required to complete this form within 30 days of student commencement to Project Officer, email address is beprojoff@ucl.ac.uk extension *34414. This is a requirement of BBSRC, therefore late submission might affect student funding.