At Tepnel Pharma Services we believe that it is our role to keep patients safe.

December 2017

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Message from the Team

Adapting in an ever-changing environment: MALS-SEC, ASAP and Fusion QbD

The services that we provide to our partners help to re-inforce their commitment to ensuring that their medicines and their manufacturing processes continuously meet and exceed the highest levels of good manufacturing practice. As part of many different global supply chain networks believe, it’s not just the right thing to do, but it’s also good business.

Healthcare provision in the 21st century is facing challenges that are unprecedented. However, we here at Tepnel believe that whatever these challenges are, keeping patients safe and improving patient outcomes are two non-negotiables as we as an industry seek to manage the economics of providing today’s healthcare options.

Developing and delivering a user experience for our partners, engaging in the delivery of their desired outcomes has become the minimum expectation that Tepnel needs to provide. Agility is a key principle in this process that says there is no end result, only an evolving, ever-present, ever-expanding life cycle of supporting drug development and improving patient outcomes.

At Tepnel we are very focussed on doing what we have done and doing it well. We recognise that there are upstream and downstream elements of the supply chain who have a depth of experience in their chosen fields that we could never try to replicate or replace.

Our heritage is in quality control analytics and we can trace our roots back to 1972, when the Royal Pharmaceutical Society of Great Britain first established training laboratories in 34 York Place in Edinburgh. Since then

we have sought to continuously develop our analytical pedigree in the scientific disciplines of chemistry and microbiology, serving a stint as an Official Medicines Control Laboratory for the then Medicines Control Agency supporting the Medicines Testing Scheme.

With a focus on batch release testing, ICH stability testing and Methods Development and Validation we have accumulated and expanded our chromatographic technologies such that we now have the following kit available on site:

kit a

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on s

ite

As December approaches, the team and Tepnel wish all our partners, collaborators and friends Seasons Felicitations and a peaceful New Year!

Waters Alliance 2690 separation modules (13) Waters 2487/2489 Ultra violet detection units (15)

Waters Alliance 2695 separation modules (2) Waters Fluorescence detection unit (3)

Waters Alliance 2695-2 separation modules (1) Waters M2414 Refractive Index detection unit (3)

Waters Acquity UPLC chromatographic systems with TUV or PDA (4) Waters ELSD HPLC detectors evaporative light scattering (2)

Waters SQD MS detectors (3) Thermo Fisher Scientific CAD (Charged Aerosol Detection) HPLC detector (1)

Waters Acquity H class chromatographic systems (1) Waters Empower® chromatography data acquisition software

Waters 996 Photo diode array detection unit (1)

FOCUS.THE TEPNEL NEWSLETTER

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Call us today on+44 (0)1506 424270 or send us an email

pharma@hologic.com to find our how we can

help your business

Continued...

Over the coming months we plan to continue to supplement our technology assets through the addition of further assets which embrace QbD and expand our commitment to working with innovator companies using complex mixtures of peptides as therapeutic agents.

One of the first of these will be the addition of the Viscotek SEC-MALS 20 multi angle light scattering detector. Designed and developed by Malvern Instruments Ltd., to measure the absolute molecular weight of proteins, synthetic and natural polymers, the detector is also capable of determining molecular size expressed as the radius of gyration, Rg. Our in house evaluation of the system has created data which we will be pleased to share as a number of white papers in the coming months.

Rapid Analytics and Quality by Design are now playing an increasingly important role in methods development and the subsequent deployment of analytical methods across stability testing. Predictive tools and technology are providing a mechanism for reigning in

some of the Millions of pounds/dollars spent throughout the drug development process.

By looking to combine these tools with lean principles and practices Tepnel are embracing new potential in refining and streamlining how we deliver our existing services.

The introduction of ASAP at Tepnel, a predictive in-silico tool that takes the data generated from accelerated temperature studies and uses Arrhenius kinetics to predict the subsequent degradation profile of the materials tested, is one example of how Tepnel are seeking to provide the same regulatory compliant data at a much lower cost. Additionally, another in house evaluation of Fusion QbD software has established that routine 30 day turnaround times can now be reduced to 10-14 days, with the added knowledge that compliance with the Quality by Design (QbD) Principles and Guidelines is built in.

Using your Values to Create Your Culture

Everyday when we walk through the front door of our facility in Livingston, we are challenged by the three values which have formed the culture of our organisation.

These three words are stencilled on the wall in our foyer and act as a re-enforcement of what the culture at Tepnel is about. At Tepnel we believe that ‘Together we are better’ whether that’s working internally with colleagues or externally with our partners, it’s all about sharing knowledge, ideas and skills. Through our people and through our principles we are constantly seeking to be progressive in how we work.

Our adoption of a Vested Outsourcing philosophy leads us to promote that the best partners have a different mind-set and that providing healthcare in the 21st century requires a different approach to how we ensure that our medicines are only about improving patient outcomes. Vested Outsourcing is a conscious shift away from a conventional “buyer-supplier” relationships to a highly collaborative “What’s in it for We” (WIIFWe) relationship aimed at developing a broad, true win-win solution. It is based around five core rules, as developed by University of Tennessee researchers, and codified into a business model and philosophy where companies and their suppliers become vested in each other’s success. Adopted and implemented by companies such as P&G, McDonald’s, and Microsoft the Vested way is instrumental in unleashing the innovation of your supply base to reduce costs and deliver outcomes rather than transactions.

People, Principled, Progressive.

Vikki.Renwick@hologic.comDavid.Scott@hologic.com

If you are interested in learning more about the Vested Way, contact Dr Vikki Renwick or Mr David Scott to arrange a free workshop on how you can achieve a different mind-set.

Tepnel.Together weare better.

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What is a Data Integrity Culture?In a nutshell it’s belief in what you do in an environment where such belief is supported by everyone. If you believe in the need for high quality data and have the knowledge to recognise it when you see it, then compliance becomes automatic and we can all sleep more easily in our beds. You have reached a state of unconscious competence.

Follow Andy McCallum our Senior Manager, Quality on LinkedIn. For Andy’s thoughts, advice or general musings on various aspects of managing GMP compliance in a QC laboratory. Visit his blog on our website: tepnelpharmaservices.com/blog

Not easily is the answer but once you have established a level of engagement, not driven down from the top but rather supported from the bottom up, then it is easy to put in place a team seeking to promote the kind of open communication which supports data integrity. The output is a team which all work in one space to one vision. Most importantly for managers and leadership is a necessity that they must support this process by adhering to an open culture and leading by example. “Led from the top, powered from below”.

At Tepnel we recognise that this is not looking for perfection but rather creating an environment where if a mistake is made then it is visible and out in the open, comprehensible and appropriate action can be taken to resolve the issue. We believe that anything else invites a failure to detect bad practice or even fraud, regulatory compliance failures and possible sanctions but most importantly danger to patients.

So, how do you do this?Andy McCallum

Brexit: Follow Tepnel for regular updates

As an organisation Tepnel is closely following and adapting our strategic planning as and when any new information is made available. We are sure that many of you are as frustrated as we are but we welcome the UK Government’s recent commitment that achieving cooperation between the UK and EU on regulation of medicines is an objective of the UK Government through the negotiations.

Tepnel Pharma Services believes that the interests of all patients are best served through a community that is working collaboratively, seeking the same outcomes within a single regulatory framework that protects and serves all patients. We consider the regulatory framework we enjoy and operate within to

be world leading in its design and operation and therefore it is our desire that the ongoing negotiations deliver a mechanism which maintains three core elements as detailed by the ABPI in their recent briefing paper following the Second reading of the European Union (Withdrawal) Bill:

• A mutual recognition agreement with the European Medicines Agency;• Continued alignment of current and future regulations;• Continued UK participation in EU regulatory and medicines safety processes.

Tepnel Pharma Services is both a member of Life Sciences Scotland with representation on the Industry Leadership Group and the Scottish Life Sciences Association. We advocate and support the position papers of both these bodies and continue to work with both to support all requisite actions to ensure that the interests of our partners and ultimately the patients that they work for to provide medicines and life changing diagnostics / medical technology, continues to be available across the whole of the European Union and European Economic Area without any replication of process or additional burdensome requirements that will challenge the economics of health care provision.

Tepnel is preparing for all possible scenarios and we intend to communicate through our newsletter, blog, LinkedIn and Twitter channels on how we aim to keep your medicines and products in the hands of those who need them.

linkedin.com/company/tepnel-pharma-services

@TepnelPharma

For more info on what Scotland has to offer visit the Life Science Scotland website www.lifesciencesscotland.com or contact Mr David Scott Industry Chair of the Pharma Services Steering Group.

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Scotland is one of the largest Life Sciences clusters in Europe, employing over 37,000 people across some 700 organisations. Companies in the sector contribute in excess of £4.2bn turnover and about £2bn gross value added to the Scottish economy. A quick scan of the Life Sciences Scotland community establishes that it is home to a range of multinationals and small to medium enterprises (SMEs) with a strong track record of creating and growing start-ups. A thriving entrepreneurial culture in our universities creates more spin-outs than any other region of the UK.

Scotland has comprehensive supply chains and world class manufacturing expertise supplying chemical and healthcare equipment, pharmaceutical services, medicines, vaccines and diagnostics to the world. Within the Pharma Services sub-sector there are >150 companies working across the whole of the drug development pipeline collaborating and supporting each other to bring an innovative approach to working with global pharmaceutical and biotechnology companies. Here at Tepnel we are happy to work with, support and recommend our colleagues in delivering first class services to the pharmaceutical industry. Here are some key facts about the Pharma Services community in Scotland:

• A world class drug discovery consortia involving the world’s biggest Pharma companies.

• A vibrant cluster of companies developing novel therapeutics including Novabiotics, TC Biopharm, MGB Biopharm and Mironid.

• Comprehensive and expert preclinical research coverage with global leaders such as Charles River Laboratories, BioReliance and Eurofins.

• Scotland is responsible for over 50% of Europe’s biosafety testing and has a large number of MHRA approved QC laboratories such as SGS Vitrology, Sartorius Stedim BioOutsource Ltd, Tepnel Pharma Services, Source Bioscience and Almac Pharma Services Ltd.

• We are a leader in the use of iPSCs (induced pluripotent stem cells) for preclinical toxicity and drug discovery.

• We have a globally recognised electronic health record system with the unique patient identifier number (CHI) used throughout a patient’s life.

• Globally competitive clinical trial recruitment and start up times (median 12 day Scotland wide R&D approval), with managed clinical trial delivery through NHS Research Scotland.

• Bio-banking resource unrivalled in Europe (Generation Scotland).

• Industry leaders in pharmaceutical manufacture. AMRI, BASF, Lonza, GSK and SAFC recognise the advantages of siting global operations in Scotland.

• Scotland is a key site for the manufacture of high potency active pharmaceutical ingredients (HPAPIs), with 17% of sites actively producing HPAPIs in Europe based in Scotland.

• Scotland produces 70% of media for biomanufacturing in Europe.

The Life Sciences Community where you go to grow!

Scotland:

tepnelpharmaservices.com | pharma@hologic.com

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