Analytical Technologies Europe: Symposium on the Practical Applications including CE, LC and MS in the Biopharmaceutical Industry (AT Europe 2019)

Transcription

1 Analytical Technologies Europe: Symposium on the Practical Applications including CE, LC and MS in the Biopharmaceutical Industry (AT Europe 2019) Symposium Co-chairs: Marta Germano, Janssen Infectious Diseases and Vaccines Carl Jone, Narwhal Sciences March 2019 Croke Park Hotel and Conference Center Dublin, Ireland Organized by

2 Table of Contents Program Partners, Exhibitors and Media Partners... 3 Student Travel Grants... 5 Social Program... 6 Acknowledgements... 7 Scientific Final Program Summary

3 The Scientific Organizing Committee gratefully acknowledges the following program partners for their generous support of this Symposium: Strategic Platinum Program Partners Biogen MedImmune Limited Strategic Gold Program Partner Novo Nordisk A/S Strategic Silver Program Partner Sanofi Gold Program Partners AbbVie Deutschland GmbH & Co KG Bruker Corporation F. Hoffman La Roche Ltd. 3

4 Exhibitors Agilent Technologies LDA UK LTD Bruker Corporation Charles River Laboratories International, Inc. Genedata Genovis AB Protagen Protein Services GmbH Protein Metrics ProZyme, a part of Agilent SCIEX Separations Thermo Fisher Scientific 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 Analytical Technologies Europe: Symposium on the Practical Applications including CE, LC and MS in the Biopharmaceutical Industry (AT Europe 2019). 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. Requirements are: Present a poster on a MS, CE, LC topic relating to biopharmaceuticals Proof of studentship/post-doc status Recommendation from your supervisor CASSS has awarded student travel grants to the following individuals: Direct Quality Control of Glycoengineered Erythropoietin Variants Tomislav Čaval, University of Utrecht, Netherlands MALDI-(in-source decay)-ft-icr MS for the Fast Characterization of New Therapeutic Antibodies Christoph Gstöttner, Leiden University Medical Center, Leiden, Netherlands Cyclodextrin Mediated Sodium Dodecyl Sulfate Removal for Capillary Electrophoresis Electrospray Ionization Mass Spectrometry of Biopharmaceuticals Daniel Sarkozy, Horváth Csaba Memorial Laboratory of Bioseparation Sciences, University of Debrecen, Hungary 5

6 Social Program Wednesday, 13 March 10:00 10:30 New Member Networking Event First time attendees of AT Europe are invited to attend a special networking event where you will be able to meet with some of our CASSS members. Make sure you have your New Member ribbon on your badge to gain access to this event. Wednesday, 13 March 17:00 18:00 Exhibitor Reception Come network and visit exhibitors in the Hogan Mezzanine Foyer. Thursday, 14 March 18:45 22:30 Conference Event This event is open to all full conference attendees. One day only attendees will be charged extra to attend. Please see registration desk for pricing. Join us for a memorable evening of food and entertainment at Ely Bar and Grill. Located in Dublin s Docklands, Ely Bar and Grill is Dublin s oldest wine venue and is settled into beautifully restored wine vaults hidden below a historic warehouse. The building was completed in 1821 by one of the most remarkable engineers of his era, John Rennie, as a cast-iron, bonded wine, tea and tobacco warehouse. Today it is home to a number of businesses, including Ely which offers fresh, flavorsome Irish food featuring organic beef, pork and lamb sourced through their own organic family farm in national Irish landmark, The Burren, Co. Clare. Transportation will be provided. Please meet CASSS staff in the lobby of the Croke Park Hotel by 18:45. 6

7 Acknowledgements Symposium Co-Chairs: Marta Germano, Janssen Infectious Diseases and Vaccines Carl Jone, Narwhal Sciences Scientific Program Committee: Christof Finkler, F. Hoffman La Roche Ltd. András Guttman, University of Debrecen Carsten Jahn, AbbVie Deutschland GmbH & Co KG Katarzyna Kozakowska, MedImmune Limited Anders Lund, Synlogic Olga Kolaj-Robin, European Pharmacopoeia Department, EDQM Cari Sänger - van de Griend, Kantisto BV Birgit Schmauser, BfArM, Federal Institute for Drugs and Medical Devices Harold Taylor, Merz Pharmaceuticals GmbH Jérôme Thiébaud, Sanofi Pasteur Hansjörg Toll, Novartis Audio-Visual: Michael Johnstone, MJ Audio-Visual Productions CASSS Staff: Karen Bertani, Director of Global Engagement and Knowledge Sharing Stephanie Flores, Executive Director Julie Fowle, Program Planning and Event Specialist Renee Olson, Senior Program Manager Catherine Stewart, Finance Manager 7

8 AT Europe 2019 Scientific Program Summary Tuesday, 12 March :30 14:00 Registration (for course attendees ONLY) in the Hogan Mezzanine Foyer 09:00 12:30 Short Course in the Nally Room Fundamentals of Mass Spectrometry in the Analysis of Protein Therapeutics Short Course Facilitator: Arjen Scholten, Janssen Vaccines and Prevention, Leiden, Netherlands 12:30 13:30 Lunch (for course attendees ONLY) 13:30 17:00 Short Course in the Nally Room Applications of Mass Spectrometry to Characterize Protein Therapeutics Short Course Facilitator: Arjen Scholten, Janssen Vaccines and Prevention, Leiden, Netherlands 8

9 Wednesday, 13 March :30 18:00 Registration in the Hogan Mezzanine Foyer 09:00 09:15 CASSS Welcome and Introductory Comments in Hogan Mezzanine II Marta Germano, Janssen Infectious Diseases and Vaccines, Leiden, Netherlands Keynote I in Hogan Mezzanine II Session Chair: Marta Germano, Janssen Infectious Diseases and Vaccines 09:15 10:00 Post-approval Flexibility in Analytical Methods Seán Barry, Health Products Regulatory Authority (HPRA), Dublin, Ireland 10:00 10:30 Networking Break Visit the Exhibits and Posters in the Hogan Mezzanine Foyer 10:00 10:30 New Member Networking Event - See Signage on Mezzanine Foyer Mass Spectrometry in Hogan Mezzanine II Session Chairs: Carsten Jahn, AbbVie Deutschland GmbH & Co KG and Katarzyna Kozakowska, MedImmune Limited 10:30 10:55 Direct Quality Control of Glycoengineered Erythropoietin Variants Tomislav Čaval, Utrecht University, Utrecht, Netherlands 10:55 11:20 Characterization of New Antibody-derived Therapeutics at the Intact and Middle-up Level using Sheathless CE-MS Elena Dominguez-Vega, Leiden University Medical Center, Leiden, Netherlands 11:20 11:45 Can Low Resolution MS Generate High-quality MAM Data and Replace High Resolution MS for Process Development Support? Scott Corley, Boehringer Ingelheim, Inc., Fremont, CA USA 11:45 12:15 Discussion 12:15 13:15 Lunch in Hogan Mezzanine I 13:15 14:45 Poster Session in the Hogan Mezzanine Foyer 14:45 15:15 Technical Seminar Essentials of Spent Media Analysis by LC/MS Donna Potts, Agilent Technologies LDA UK Ltd, Cheadle, United Kingdom Sponsored by Agilent Technologies Hogan Mezzanine II 9

10 Wednesday, 13 March 2019 continued Capillary Electrophoresis in Hogan Mezzanine II Session Chairs: Christof Finkler, F. Hoffman La Roche Ltd. and Jérôme Thiébaud, Sanofi Pasteur 15:15 15:40 Extending the Range - Affinity Capillary Electrophoresis in Charge Heterogeneity Profiling Steffen Kiessig, F. Hoffman La Roche Ltd., Basel, Switzerland 15:40 16:05 Capillary Electrophoresis Sodium Hexadecyl Sulfate (CE-SHS): The Use of Alternative Detergents to Quantify the Purity of Hard-To-Denature Proteins Jeff Beckman, Bristol-Myers Squibb Company, Devens, MA USA 16:05 16:30 Validation of a Fast and High-Resolution Capillary Electrophoresis Based mab N-glycan Profiling Method Ákos Szekrenyes, Glenmark Pharmaceuticals SA, La Chaux-de-Fonds, Switzerland 16:30 17:00 Discussion 17:00 18:00 Exhibitor Reception in the Hogan Mezzanine Foyer 10

11 Thursday, 14 March :30 17:30 Registration in the Hogan Mezzanine Foyer Keynote II in Hogan Mezzanine II Session Chair: Cari Sänger - van de Griend, Kantisto BV 09:00 09:45 Strategies for the Separation of Complex Samples Peter Schoenmakers, University of Amsterdam, Amsterdam, Netherlands 09:45 10:15 Networking Break Visit the Exhibits and Posters in the Hogan Mezzanine Foyer Liquid Chromatography in Hogan Mezzanine II Session Chair: András Guttman, University of Debrecen 10:15 10:40 On the Versatility of 2D-LC in Biopharmaceutical Analysis Koen Sandra, Research Institute for Chromatography, Kortrijk, Belgium 10:40 11:05 High-Throughput, Multi-Attribute Continuous Product Characterisation Platform for Increased Process Control Monitoring Noemi Dorival-Garcia, NIBRT, Dublin, Ireland 11:05 11:30 Fast, Selective and Quantitative Protein Profiling of Adenovirus-vector Based Vaccines by Ultra-performance Liquid Chromatography Tom Branson, Janssen Vaccine and Prevention, Lieden, Netherlands 11:30 12:00 Discussion 12:00 12:30 Technical Seminar Glycosylation Profiling of Biopharmaceuticals using Cutting-edge Mass Spectrometry Techniques and an Advanced Data Processing Platform Lucio Manzi, Merck KGaA, Guidonia Montecelio, Italy Sponsored by Genedata Hogan Mezzanine II 12:30 13:30 Lunch in Hogan Mezzanine I Host Cell Proteins in Hogan Mezzanine II Session Chair: Marta Germano, Janssen Infectious Diseases and Vaccines 13:30 13:50 The Increasing Need to use Mass Spectrometry to Identify and Monitor HCPs in Biologics Severine Clavier, Sanofi, Vitry-sur-seine, France 13:50 14:10 Host Cell Proteins: Current Strategies and Future Directions Markus Haindl, Roche Diagnostics GmbH., Penzberg, Germany 11

12 Thursday, 14 March 2019 continued 14:10 14:30 MS-based Host Cell Protein Testing Strategy for a Vaccine Manufactured in a Novel Cell Line Annemiek Verwilligen, Janssen Vaccines & Prevention, Leiden, Netherlands 14:30 14:50 Identification and Quantification of Polysorbate-degrading Host Cell Protein Impurities in Biopharmaceuticals using Advanced Mass Spectrometry-based Techniques Michael Zorn, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riß, Germany 14:50 15:20 Discussion 15:20 15:50 Technical Seminar Mass Spectrometry and EPR in your Biologics Workflow: How to Get Speed and Depth in your Host Cell Protein (HCP) Analysis Michael Greig, Bruker Daltontics, Inc., Billerica, MA USA Analysis of Shelf-Life of Polysorbates by Electron Paramagnetic Resonance (EPR) Spectroscopy in 60 min Sukhvinder Chohan, Bruker BioSpin UK, Coventry, United Kingdom Sponsored by Bruker Corporation Hogan Mezzanine II 15:50 17:20 Poster Session in the Hogan Mezzanine Foyer 17:20 18:20 Roundtable Session in Hogan Mezzanine I Session Chairs: Marta Germano, Janssen Infectious Diseases and Vaccines and Carl Jone, Narwhal Sciences 18:45 22:30 Conference Event 12

13 Friday, 15 March :30 15:00 Registration in the Hogan Mezzanine Foyer Keynote III in Hogan Mezzanine II Session Chair: Christof Finkler, F. Hoffman La Roche Ltd. 09:00 09:45 Bioanalysis of Biopharmaceuticals by Liquid Chromatography - Mass Spectrometry Rainer Bischoff, University Groningen, Groningen, Netherlands 09:45 10:15 Networking Break Visit the Exhibits and Posters in the Hogan Mezzanine Foyer Structure-Function Studies in Hogan Mezzanine II Session Chairs: Carl Jone, Narwhal Sciences and Harold Taylor, Merz Pharmaceuticals GmbH 10:15 10:40 Picking-up Product Degradation by Bioassay. Function and Structure Pieces of the Puzzle Annemie Wielant, UCB Pharma SA, Brussels, Belgium 10:40 11:05 Understanding the 3-dimensional Structures of a Peptide and Biological Activity Testing in Commercial Operations Mark Drew, AstraZeneca, Cheshire, United Kingdom 11:05 11:30 Comparability Studies of Pharmaceutical Proteins by 2D NMR Fingerprint Joan Malmstrøm, Novo Nordisk A/S, Måløv, Denmark 11:30 12:00 Discussion 12:00 12:30 Technical Seminar Identification and Tracking of Problematic Host Cell Proteins Through Downstream Bioprocessing of Monoclonal Antibodies Jonathan Bones, NIBRT, Dublin, Ireland Sponsored by Thermo Fisher Scientific Hogan Mezzanine II 12:30 13:30 Lunch in Hogan Mezzanine I 13

14 Friday, 15 March 2019 continued Regulatory Session in Hogan Mezzanine II Session Chair: Carl Jone, Narwhal Sciences and Birgit Schmauser, BfArM, Federal Institute for Drugs and Medical Devices 13:30 13:55 European Pharmacopoeia - Recent Developments in the Field of Biopharmaceuticals Olga Kolaj-Robin, EDQM, Strasbourg, France 13:55 14:20 HELP WANTED: A Regulatory Perspective on Opportunities for Analytical Methods in Biopharmaceutical Development Joel Welch, CDER, FDA, Silver Spring, MD USA 14:20 14:45 Regulatory Challenges for Biopharmaceuticals Maeve Lally, Health Products Regulatory Authority (HPRA), Dublin, Ireland 14:45 15:15 Discussion 15:15 15:30 Closing Comments in Hogan Mezzanine II 14