This education course is recognised for the ECA GMP Certification Programme „Microbiological Laboratory Manager“. Please find details at www.gmp-certification.eu

27-28 February 2018, Munich/Bernried, Germany

Practical Laboratory Trainingin small groups –

max 15 participants.

SPEAKERS:

Dr Ingo CiolkowskiLonza Cologne GmbH

John DubczakCharles River Laboratories

Stefan GärtnerLabor L+S AG

Dr Holger GrallertHyglos GmbH

Thomas PotrawfkeHaemochrom Diagnostica

Johannes ReichMicrocoat Biotechnologie GmbH

Dr Friedrich von WintzingerodeRoche Diagnostics GmbH

Kevin WilliamsbioMérieux

WA/07072017

Low EndotoxinRecovery/Masking Hands-on Laboratory Training Course

HIGHLIGHTS:

� Interpretation of interference during Endotoxin detection

� Understanding Low Endotoxin Recovery (LER)

� Setup of hold-time studies

� Techniques for demasking Endotoxin

Objectives

� How to identify Low Endotoxin Recovery (LER) � How to Set-up hold-time studies � Analysis of influencing factors (Sample matrices,

endotoxin, temperature, detection methods, etc.) � Understanding the driving forces of LER � Interpretation of test results � Dedicated sample treatment for demasking

Background

In the last years the LAL test has become the preferred system to test for endotoxins – for the in-process control as well as in the final inspection – and it is anchored in the pharmacopoeias. However, in the recent past, the problem of low endotoxin recovery employs the phar-maceutical microbiology. Masking – or not? Evidence gaps? And how can I close them? And how to evaluate?

These are the questions the pharmaceutical microbiolo-gists as well as those responsible for the release have to deal with.

And last but not least, how can we handle the test in daily business in a practical manner?

Target Audience

� Laboratory management and staff of pharmaceutical microbiology

� Microbiologists and laboratory assistants from contract laboratories

� Scientific staff from the area Endotoxin testing

Social Event

On the first course day, you are cordially invited to a so-cial event. This is an excellent opportunity to share your experiences with colleagues from other companies in a relaxed atmosphere.

Moderators

Dr Johannes Reich, Microcoat, Axel H. Schroeder, Concept Heidelberg

Programme

Endotoxin Detection Methods I � Definition of Endotoxins � Nature of Endotoxin � General detection methods

Thomas Potrawfke, Haemochrom Diagnostica

Endotoxin Detection Methods II � Basic reaction of Limulus-based detection methods � Sample handling � Construction and interpretation of standard curve

Dr Ingo Ciolkowski, Lonza Cologne GmbH

LER: Reflecting on Biopharmaceutical Operational Reality

� Mechanisms of LER can be influenced by LPS stability � Varying size and fragility of LPS aggregates can be

directly correlated to presence of chelating agents and detergents

� Elucidating conformational changes, in real time, on LPS using HSAFM

John Dubczak, CRL

Test Interference � Postitive Product Control (PPC) � Test inhibition � Test enhancement

Stefan Gärtner, L+S

Endotoxin Recovery Studies for the Detection of Endotoxin Masking Effects

� Endotoxin Masking � Planning and implementation of hold-time studies � Interpretation of hold-time studies

Dr Friedrich von Wintzingerode, Roche Diagnostics GmbH

Demasking of Endotoxin � Mechanistic principles of demasking � Development of demasking protocols � Implementation of demasking protocols

Johannes Reich, Microcoat GmbH

Sample Preparation for Demasking � Practical demasking procedure � Preparation of reagents for demasking � Application of demasking protocols

Dr Holger Grallert, Hyglos GmbH

Low Endotoxin Recovery/Masking

27-28 February 2018, Munich/Bernried, Germany

Image: Charles River

Image: Labor L+S

Biologics are Different � Microbiological Control � The new science of immunological control

Kevin Williams, bioMérieux

Round Table Discussion Practical Laboratory Work (Microcoat GmbH)

Simulation of contamination in various sample matrices

� Preparation of samples affected by – Test interference – Sample interference

Endotoxin Service Team, Microcoat GmbH

Analysis of interference in affected samples � Application of different detection systems

– Limulus Amebocyte Lysate assay – Recombinant Factor C assay

Endotoxin Service Team, Microcoat GmbH

Sample treatment for demasking � Screening for demasking protocol � Optimization of demasking protocol � Evaluation of demasking protocol

Endotoxin Service Team, Microcoat GmbH

Interpretation and Comparison of Results � Differentiation between test and sample interference � Effects of different detection systems � Demasking of endotoxin

Endotoxin Service Team, Microcoat GmbH

Closing Remarks (ECA Academy)

Speakers

Dr Ingo Ciolkowski, Lonza Cologne GmbH, GermanyDr Ciolkowski studied at the University of Kaiserslautern, and Cologne where he finished his PhD at the Max-Planck-Institute for Plant Breeding Research. After his degree, he worked as re-search scientist at the University Gießen. From 2007 – 2011 he was employed at QIAGEN. Since 2011 he is Scientific Support Specialist at Lonza and handles all Endotoxin related questions as well as manages the application lab for LAL assay trouble shooting.

John Dubczak, General Manager at Charles River, USAPrior to joining Charles River, John was a long-term employee of Baxter Healthcare Corp., where he developed Baxter’s pro-prietary LAL formulation and manufacturing process. As a mem-ber of the R&D team, he also developed methods for product testing and explored the clinical applications of LAL. With sev-en years of LVP manufacturing experience, he brings an in-depth understanding of issues surrounding all aspects of LAL testing in the pharmaceutical industry.

Stefan Gärtner, Labor L+S AG, Bad Bocklet, GermanyAfter his qualification as biological laboratory technician at L+S AG Stefan worked as technical specialist at L+S. 2015 he fin-ished his studies at Provadis School of International Manage-ment and Technology wit a BSc in Biopharmaceutical Sciences. Since May, he is head of a speciality department at L+S AG.

Dr Holger Grallert, Hyglos GmbH, Bernried, GermanyDr Holger Grallert is Vice President Research and Development at Hyglos GmbH, Bernried, Germany. His unit is focused on the improvement of existing and development of new analytical methods in the field of Bacterial Endotoxins. He brings twenty years of microbiology and biochemistry expertise in the devel-opment and introduction of diagnostic and preparative tools to academic and industrial marketplaces. Beforehand, he studied Biology at the University of Regensburg and received his PhD from the Technical University of Munich.

Thomas Potrawfke, Haemochrom Diagnostica, GermanyThomas Potrawfke has a degree in Biology from the Technical University Braunschweig where he focused on microbiology and biochemistry. He started at Lonza (formerly BioWhittaker (Cambrex)) in 2000, where he held various positions, in the end as Key Account Manager. Most recently he joined Haemo-chrom Diagnostica as a Product Manager, a company experi-enced in haemostasis diagnostics and endotoxin analytics for more than 20 years.

Johannes Reich, Microcoat Biotechnologie GmbH, GermanyJohannes Reich studied business administration and chemistry in Regensburg. Currently, he is working on his doctoral thesis on “function-structure relationship of Lipopolysaccharide with recombinant factor C test systems” at the Institute for physical and theoretical chemistry. He deals with the problems of mod-ern endotoxin detection methods and with the problem of low endotoxin recovery. In the meantime he worked as product manager at Profos AG in Regensburg.

Kevin Williams, bioMérieux, USA Kevin is a recognized expert in the endotoxin detection field with over 30 years of experience in Pharma (Eli Lilly, Hospira and Lonza). He authored and edited the 2nd and 3rd editions of “Endotoxins” book from Informa Healthcare as well as au-thoring many journal articles in PDA, BioPharm, Pharmaceutical Technology, and American Pharmaceutical Review. He is often a speaker at PDA and other microbiological focused confer-ences.

Dr Friedrich von Wintzingerode, Roche Diagnostics GmbH, Germany Friedrich studied biology with focus on Microbiology at Techni-cal University Braunschweig. Diploma at German Strain Culture Collection (DSMZ), Braunschweig. Degree at Institute of Micro-biology and Hygiene, Charité, Berlin. Since 2001 employed at Roche Diagnostics as group leader Environmental monitoring and cleaning analytics and since 2005 group leader microbio-logical IPC and analytics for release. Friedrich is Head of a glob-al working group for microbial identification within Roche and Senior Manager QC Microbiology. Lead of Endotoxin Expert Group Roche/Genentech.

Rese

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Date

Tuesday, 27 February 2018, 09.30 – 17.30 h(Registration and coffee 09.00 - 09.30 h)Wednesday, 28 February 2018 , 08.30 – 17.00 h

Overnight Stay

Hotel MarinaAm Yachthafen 1-1582347 Bernried am Starnberger See, GermanyPhone +49(0)8158 -9320Fax +49(0)8158-7117info@hotelmarina.de

Accommodation

CONCEPT HEIDELBERG has reserved a limited number of rooms in the conference hotel. You will receive a room reser-vation form when you have registered for the event. Please use this form to receive the specially negotiated rate for the duration of your stay. Reservation should be made directly with the hotel no. Early reservation is recommended.

Venue of the Laboratory Course

Microcoat Biotechnologie GmbHAm Neuland 3, 82347 Bernried am Starnberger See

Transfer service from Marina Hotel to Microcoat in the morning and back in the evening will be organised

Shuttle Service from/to Munich Airport

On 26 February at appr. 19.00 from Munich Airport to Bernried Marina Hotel.On 28 February at approx. 17.15 h from Microcoat to Munich Airport.

Fees (per delegate plus VAT)

ECA Members € 1,690APIC Members € 1,790Non-ECA Members € 1,890EU GMP Inspectorates € 945The conference fee is payable in advance after receipt of invoice and includes conference documentation, dinner on the first day, lunch on both days and all refreshments. VAT is reclaimable

Registration

Via the attached reservation form, by e-mail or by fax message. Or you register online at www.gmp-compliance.org.

Conference Language

The official conference language will be English.

Organisation and Contact

ECA has entrusted Concept Heidelberg with the organisation of this event.

CONCEPT HEIDELBERGP.O. Box 10 17 64, D-69007 Heidelberg, GermanyPhone +49 (0) 62 21/84 44-0, Fax +49 (0) 62 21/84 44 34info@concept-heidelberg.de, www.concept-heidelberg.de

For questions regarding content:Mr Axel H Schroeder (Operations Manager) at +49-62 21 / 84 44 10, schroeder@concept-heidelberg.de

For questions regarding reservation, hotel, organisation etc.:Ms Marion Weidemaier (Organisation Manager) at +49-62 21 / 84 44 46, weidemaier@concept-heidelberg.de.

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Reservation Form:CONCEPT HEIDELBERGP.O. Box 10 17 6469007 HeidelbergGermany

Reservation Form:+ 49 6221 84 44 34 @ e-mail:

info@concept-heidelberg.de Internet:www.gmp-compliance.org

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