Analytical Technologies Europe: Symposium on the Practical Applications including CE, LC and MS in the Biopharmaceutical Industry (AT Europe 2015)

Transcription

1 Analytical Technologies Europe: Symposium on the Practical Applications including CE, LC and MS in the Biopharmaceutical Industry (AT Europe 2015) Symposium Co-Chairs: Cari Sänger - van de Griend, Kantisto BV Hansjörg Toll, Sandoz GmbH March, 2015 The Westin Grand Berlin Berlin, Germany Organized by

2 Table of Contents Program Partners, Exhibitors and Media Partners... Student Travel Grants... Acknowledgements... Scientific Final Program Summary... Session Abstracts... Workshop I Description... Technical Seminar Abstract... Poster Abstracts... 2

3 The Organizing Committee gratefully acknowledges the following program partners for their generous support of this Symposium: Sustaining Platinum Program Partner MedImmune Platinum Program Partners F. Hoffmann - La Roche Ltd. Genedata GmbH Gold Program Partner Bruker Daltonik Exhibitors Agilent Technologies LSG Bruker Daltonik Europa Bioproducts Ltd. Genedata GmbH Genovis AB Postnova Analytics GmbH Protagen Protein Services GmbH ProteinSimple SCIEX Separations, a part of AB SCIEX Thermo Scientific Wyatt Technology Europe 3

4 Media Program Partners The Analytical Scientist BioProcess International Genetic Engineering & Biotechnology News International Pharmaceutical Quality LCGC Europe The Medicine Maker The Pathologist Royal Society of Chemistry separationsnow.com Technology Networks Limited Supporting Organization Gesellschaft Deutscher Chemiker (GDCh) 4

5 CASSS AT Europe Student Travel Grants CASSS is pleased to provide a limited number of student travel grants for PhD students and post-docs who present applicable posters at the inaugural Analytical Technologies Europe: Symposium on the Practical Applications including CE, LC and MS in the Biopharmaceutical Industry (AT Europe 2015). PhD students or post-doctoral fellows conducting research at academia throughout the world are eligible. Why you should apply: This Symposium is an active forum for discussion of recent developments and regulatory considerations of the practical application of analytical technologies amongst industry, academia and regulatory agencies. There will be a focus on capillary electrophoresis, mass spectrometry and chromatography for product characterization, process monitoring, formulation development and release testing in the biopharmaceutical industry. As a participant, you will have an excellent opportunity to meet, network and participate in exchanging knowledge for mutual education with your peers. How do you apply: Please send a letter requesting consideration for the grant, a letter of recommendation from your supervisor, proof of your university affiliation and a PDF of your abstract to the Symposium Manager Renee Olson (rolson@casss.org). Application for a travel grant does not release you from the obligation to register and submit your abstract online. Requirements are: - Present a poster on a MS, CE, LC topics relating to Biopharmaceuticals - Proof of studentship/post-doc status - Recommendation from your supervisor The deadline to apply for a student travel grant is Friday, 13 February

6 Social Program Wednesday, 18 March 18:15 19:15 Exhibition Reception Come network and visit exhibitor and posters in the Salon Foyer. Thursday, 19 March 18:30 22:00 Conference Event This event is open to all full conference attendees. One day only attendees will be charged extra to attend. This event will take place at the Kaisersall (Emperor s Saloon) in the Palmenhof and Silbersall rooms. This original venue from 1907 is located in Potsdamer Platz. Postdamer Platz is considered the new city center of Berlin and the former no-man s land. Today this location is considered the connection place between East and West. This is a venue where Past meets the Future and is what Berlin stands for. The event will include a minute tour of Berlin and dinner. 6

7 Symposium Co-Chairs: Cari Sänger - van de Griend, Kantisto BV Hansjörg Toll, Sandoz GmbH Acknowledgements Scientific Program Committee: Martin Blüggel, Protagen Protein Services GmbH Francois de l Escaille, Analis s.a./n.v. Christof Finkler, F.Hoffmann La Roche Ltd. Anders Lund, Genzyme, a Sanofi Company Andras Guttman, Northeastern University Birgit Schmauser, BfArM, Federal Institute for Drugs and Medical Devices Harold Taylor, Merz Pharmaceuticlas GmbH Audio-Visual: Michael Johnstone, MJ Audio-Visual Productions CASSS Staff: Stephanie Flores, Executive Director Renee Olson, Senior Program Manager Anna Lingel, Project Coordinator Catherine Stewart, Finance Manager 7

8 AT Europe 2015 Scientific Final Program Summary Tuesday, 17 March, :30 09:00 Buffet Breakfast in Restaurant Coelln 06:30 10:30 Buffet Breakfast in Restaurant Coelln (for accompanying guests) 08:30 14:00 Registration (for course attendees ONLY) in the TBD 09:00 17:00 Short Course in Wintergarten Room Reliable Methods in Capillary Electrophoresis: Fundamentals and Good Working Practice Short Course Facilitators: François de l'escaille, Analis s.a./n.v., Namur, Belgium and Cari Sänger - van de Griend, Kantisto BV, Baarn, The Netherlands 12:30 13:30 Hosted Lunch (for course attendees ONLY) in the Coelln Room 8

9 Wednesday, 18 March, :30 18:00 Registration in the Club Diana 06:30 09:00 Buffet Breakfast in Restaurant Coelln 06:30 10:30 Buffet Breakfast in Restaurant Coelln (for accompanying guests) 09:00 09:05 CASSS Welcome and Introductory Comments in Salon Unter den Linden/Friedrichstadt Frantisek Svec, CASSS President, Emeryville, CA USA 09:05 09:15 Meeting Welcome and Introductory Comments in Salon Unter den Linden/Friedrichstadt Cari Sänger - van de Griend, Kantisto BV, Baarn, The Netherlands Keynote I Session in Salon Unter den Linden/Friedrichstadt Session Chair: Cari Sänger - van de Griend, Kantisto BV, Baarn, The Netherlands 09:15 10:15 Analytical Sciences in Biotechnology: Opportunities and Challenges Wassim Nashabeh, F. Hoffmann La Roche Ltd., Basel, Switzerland 10:15 10:45 Break Visit the Exhibits and Posters the Salon Foyer Interface Development and Quality Control Session in Salon Unter den Linden/Friedrichstadt Session Chair: Harold Taylor, Merz Pharmaceuticals GmbH, Frankfurt Am Main, Germany 10:45 11:10 Charge Heterogeneity by CZE: A Test Method fit for QC Testing? Marc Hassel, Novartis Pharma AG, Basel, Switzerland 11:10 11:35 But It Always Works for ME! R&D vs QC Methods for Biotech Products Nadine Ritter, The Global Biotech Experts Collaborative, LLC, Germantown, MD USA 11:35 12:00 The Regulatory Role of Mass Spectrometry for the Characterization of Peptides, Proteins, and Monoclonal Antibodies Michael Boyne, CDER, FDA, Silver Spring, MD USA (tentative) 12:00 12:30 Discussion 12:30 13:30 Buffet Lunch in Restaurant Coelln 13:30 14:30 Poster Session in Salon Foyer 9

10 Wednesday, 18 March, 2015 New Trends in Capillary Electrophoresis Session in Salon Unter den Linden/Friedrichstadt Session Chair: François de l'escaille, Analis s.a./n.v., Namur, Belgium 14:30 14:55 Development of High-throughput MCE Assays for Classical and Novel Biotherapeutics Friederike Winkhaus, Roche Diagnostics GmbH, Penzberg, Germany 14:55 15:20 Capillary Electrophoresis for the Quantification of Adenovirus Particles for Process Development Support Ewoud van Tricht, Crucell Holland BV, Leiden, The Netherlands 15:20 15:45 Application of Capillary Electrophoresis for the Standardization of Measurements of Protein Biomarkers for In-Vitro Diagnostics Guy Auclair, European Commission, Geel, Belgium 15:45 16:15 Discussion 16:15 17:15 Technical Seminar Expanding the Role of Capillary Electrophoresis Combined with Mass Spectrometry Detection (CE-MS) for the Development, Characterization & Control of Biologics Stephen Lock, SCIEX, Separations, Pudsey, United Kingdom Milla Neffling, AB SCIEX, Warrington, United Kingdom Sponsored by SCIEX Separations Salon Unter den Linden/Friedrichstadt 17:15 18:15 Workshop I: Roud Robin Tabletop Discussion in Salon Unter den Linden/Friedrichstadt Session Chair: Hansjörg Toll, Sandoz GmbH, Kundl, Austria 18:15 19:15 Exhibition Reception Visit the Salon Foyer 10

11 Thursday, 19 March, :30 17:00 Registration in the Club Diana 06:30 09:00 Buffet Breakfast in Restaurant Coelln 06:30 10:30 Buffet Breakfast in Restaurant Coelln (for accompanying guests) Method Development and QbD Session in Salon Unter den Linden/Friedrichstadt Session Chair: Christof Finkler, F. Hoffmann La Roche Ltd., Basel, Switzerland 09:00 09:25 TBD Melissa Hanna-Brown, Pfizer, Inc., Sandwich, UK 09:25 09:50 Quality Aspects in the Research Laboratory - Method Development Katalin Ganzler, Gedeon Richter Plc. Budapest, Hungary 09:50 10:15 TBD Oliver Grosche, Novartis Pharma AG, Basel, Switzerland 10:15 10:45 Discussion 10:45 11:15 Break Visit the Exhibits and Posters in Salon Foyer Post Translational Modification s Session in Salon Unter den Linden/Friedrichstadt Session Chair: András Guttman, Northeastern University, Boston, MA USA 11:15 11:40 CE and UPLC: Complementary High-hand Tools to Tune N-glycosylation of Therapeutic Proteins Ana Krstanovic, Merck Serono, Corsier sur Vevey, Switzerland 11:40 12:05 In Depth Chracterization of Biotherapeutics by Mass Spectrometry - A Case Study Udo Roth, Sanofi-Aventis Deutschland GmbH, Frankfurt am Main, Germany 12:05 12:30 Emerging mass spectrometry based methods for therapeutic mabs, biosimilars and ADCs deep structural characterization Elsa Wagner-Rousset, Centre d Immunologie Pierre Fabre, Saint Julien en Genevois, France 12:30 13:00 Discussion 13:00 14:15 Buffet Lunch in Restaurant Coelln 11

12 14:15 14:45 Thursday, 19 March, 2015 Technical Seminar Tackling the Data Analysis Challenge for Deep MS-based Characterization of Biotherapeutics Carsten P. Soenksen, Novo Nordisk Sponsored by Genedata GmbH Salon Unter den Linden/Friedrichstadt New Trends in Mass Spectrometry Session in Salon Unter den Linden/Friedrichstadt Session Chairs: Martin Blüggel, Protagen Protein Services GmbH, Dortmund, Germany 14:45 15:10 New approaches for PK profiling of glycol-variants to support criticality assessment during early development Andreas Seidl, Sandoz Biopharmaceuticals Oberhaching HEXAL AG, Oberhaching, Germany 15:10 15:35 Top-down and Middle-up Hydrogen/deuterium Exchange Mass Spectrometry for Accurate, Sensitive and Comprehensive Structural Characterization of Biosimilars Christoph Borchers, University of Victoria, Victoria, BC Canada 15:35 16:00 Proteomic Characterization of Harvest Cell Culture Fluid in Support of Host Cell Protein Immunoassay Development Christopher Yu, Genentech, a Member of the Roche Group, South San Francisco, CA USA 16:00 16:25 Quantitative Protein Expression Determination for Biologics and Vaccines by Mass Spectrometry Arjen Scholten, Janssen Infectious Diseases and Vaccines Curcell Holland BV, Leiden, The Netherlands 16:25 16:55 Discussion 16:55 17:10 Break - Visit the Exhibits and Posters in Salon Foyer 17:10 18:10 Technical Seminar TBD Sponsored by Bruker Daltonik Salon Unter den Linden/Friedrichstadt 18:30 22:00 Conference Event Location and more information coming soon. 12

13 Friday, 20 March, :30 12:00 Registration in the Club Diana 06:30 09:00 Buffet Breakfast in Restaurant Coelln 06:30 10:30 Buffet Breakfast in Restaurant Coelln (for accompanying guests) CE-MS Session in Salon Unter den Linden/Friedrichstadt Session Chair: Cari Sänger - van de Griend, Kantisto BV, Baarn, The Netherlands 09:00 09:25 Simultaneous Determination of Protein Affinity and Heterogeneity by Capillary Electrophoresis-mass spectrometry Rob Haselberg, VU University, Amsterdam, The Netherlands 09:25 09:50 TBD Göran Hübner, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riss, Germany 09:50 10:15 In-line-SPE-CE-MS for the Analysis of Glycans and Proteins - Concepts and Recent Results Christian Neusüß, Aalen University, Aalen, Germany 10:15 10:45 Discussion 10:45 11:15 Break - Visit the Exhibits and Posters in Salon Foyer Regulatory Session in Salon Unter den Linden/Friedrichstadt Session Chair: Birgit Schmauser, BfArM, Federal Institute for Drugs and Medical Devices, Bonn, Germany 11:15 11:40 Regulatory Perspectives on Advanced Analytical Methods used for Characterization and Control of Biopharmaceutical Products Sarah Kennett, CDER, FDA, Silver Spring, MD USA 11:40 12:05 Regulatory Interpretation of Characterisation Studies Martijn Van de Plas, CBG-MEB, Utrecht, The Netherlands 12:05 12:35 Discussion 12:35 12:40 Closing Comments in Salon Unter den Linden/Friedrichstadt Hansjörg Toll, Sandoz GmbH, Kundl, Austria 13