Analytical Technologies Europe: Symposium on the Practical Applications including CE, LC and MS in the Biopharmaceutical Industry (AT Europe 2016) Symposium Co-Chairs: Cari Sänger - van de Griend, Kantisto BV Hansjörg Toll, Sandoz GmbH 15-18 March, 2016 Imperial Riding School Renaissance Hotel Vienna, Austria Organized by
Table of Contents Program Partners, Exhibitors and Media Partners... Student Travel Grants... Social Program... Acknowledgements... Scientific Final Program Summary... Session Abstracts... Round Robin Table Description... Technical Seminar Abstract... Poster Abstracts... 2
The Organizing Committee gratefully acknowledges the following program partners for their generous support of this Symposium: Sustaining Platinum Program Partners AbbVie, Inc. MedImmune, A member of the AstraZeneca Group Sustaining Gold Program Partner Novo Nordisk A/S Platinum Program Partner Genedata GmbH Gold Program Partners Bruker Daltonik F. Hoffmann La Roche Ltd. Exhibitors Bruker Daltonik Genovis AB Waters Corporation 3
The Scientific Organizing Committee gratefully acknowledges the following media for their promotional consideration of AT Europe 2016: Media Program Partners Analyst Analytical Methods The Analytical Scientist BioProcess International International Pharmaceutical Quality The Medicine Maker The Pathologist separationsnow.com Technology Networks 4
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 2016). 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 topics relating to Biopharmaceuticals - Proof of studentship/post-doc status - Recommendation from your supervisor Deadline for submissions is Friday, December 18. 5
Social Program Wednesday, 16 March 18:00 19:00 Exhibition Reception Come network and visit exhibitors in the Linke Pirouette Room. Thursday, 17 March 19:00 22:00 Conference Event This event is open to all full conference attendees. One day only attendees will be charged extra to attend. Please see the registration desk for pricing. Location TBD. 6
Symposium Co-Chairs: Cari Sänger - van de Griend, Kantisto BV Hansjörg Toll, Sandoz GmbH Acknowledgements Scientific Program Committee: Martin Blüggel, Protagen Protein Services GmbH François de l Escaille, Analis s.a./n.v. Christof Finkler, F.Hoffmann La Roche Ltd. Marta Germano, Janssen Infectious Diseases and Vaccines András Guttman, Northeastern University Anders Lund, Genzyme, a Sanofi Company Birgit Schmauser, BfArM, Federal Institute for Drugs and Medical Devices Jeremy Springall, MedImmune, A member of the AstraZeneca Group Harold Taylor, Merz Pharmaceuticals 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
AT Europe 2016 Scientific Final Program Summary Tuesday, 15 March, 2016 08:30 14:00 Registration (for course attendees ONLY) in the Foyer Reitschule 09:00 12:30 Short Course in Haute Ecole Room Fundamentals of Mass Spectrometry in the Analysis of Protein Therapeutics Short Course Facilitator: Anders Lund, Genzyme, a Sanofi Company, Framingham, MA USA 09:00 17:00 Short Course in Kleine Reitschule 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 Borromäus Restaurant 13:30 17:00 Short Course in Haute Ecole Room Applications of Mass Spectrometry to Characterize Protein Therapeutics Short Course Facilitator: Anders Lund, Genzyme, a Sanofi Company, Framingham, MA USA 8
08:30 18:00 Registration in the Foyer Wednesday, 16 March, 2016 09:00 09:15 Welcome and Introductory Comments in Rechte Pirouette Room Hansjörg Toll, Sandoz GmbH, Kundl, Austria Keynote I Session in Rechte Pirouette Room Session Chair: Hansjörg Toll, Sandoz GmbH, Kundl, Austria 09:15 10:15 Biosimilar Development and the Role of Analytical Technologies Martin Schiestl, Sandoz GmbH, Kundl, Austria 10:15 10:45 Break Visit the Exhibits and Posters the Linke Pirouette Room Process and Product Characterization Session in Rechte Pirouette Room Session Chairs: François de L Escaille, Analis SA, Suarlee, Belgium and Marta Germano, Janssen Infectious Diseases and Vaccines, Leiden, The Netherlands 10:45 11:10 mab Characterization by Mass Spectrometry: from Routine Comparability/Stability Studies to Structural Investigation Francois Debaene, Sanofi-aventis, Vitry-sur-Seine, France 11:10 11:35 TBD Christian Huber, University of Salzburg, Salzburg, Austria 11:35 12:00 TBD 12:00 12:30 Discussion 12:30 13:30 Buffet Lunch in Borromäus Restaurant 13:30 15:00 Poster Session in the Linke Pirouette Room New Trends Analytical Technologies in Rechte Pirouette Room Session Chairs: Martin Blüggel, Protagen Protein Services GmbH, Dortmund, Germany and Harold Taylor, Merz Pharmacuticals GmbH, Frankfurt Am Main, Germany 15:00 15:25 Analytical Approaches to Understanding of Therapeutic Protein Quality Attributes in vivo Yelena Lyubarskaya, Biogen, Cambridge, MA USA 15:25 15:50 TBD Guinevere Kammeijer, Leiden University Medical Center 15:50 16:15 TBD 16:15 16:45 Discussion 9
16:45 17:00 Mini Break 17:00 18:00 Technical Seminar Wednesday, 16 March, 2016 Sponsored by Bruker Daltonik Rechte Pirouette Room 18:00 19:00 Exhibition Reception Visit the Linke Pirouettee Room 10
Thursday, 17 March, 2016 08:30 17:00 Registration in the Salon Foyer Quality by Design Innovative Method Development Session in Rechte Pirouette Room Session Chairs: Cari Sänger - van de Griend, Kantisto BV, Baarn, The Netherlands and Jeremy Springall, MedImmune, A member of the AstraZeneca Group, Cambridge, United Kingdom 09:00 09:25 TBD Melissa Hanna-Brown, Pfizer, Inc., Sandwich, United Kingdom 09:25 09:50 Designing Quality: Quality by Design in Analytical Pharmaceutical Development Luca Nompari, GlaxoSmithKline, Siena, Italy 09:50 10:15 Benefits of Applying QbD Concepts to Analytical Methods for Therapeutic Proteins - Case Studies Annick Gervais, UCB Pharma SA, Braine l Alleud, Belgium 10:15 10:45 Discussion 10:45 11:15 Break Visit the Exhibits and Posters in the Linke Pirouette Room 11:15 12:15 Roundtable Discussions Topics TBD Rechte Pirouette Room 12:15 13:15 Buffet Lunch in Borromäus Restaurant Analytical Technologies in the QC Environment Session in Rechte Pirouette Room Session Chair: Anders Lund, Genzyme, a Sanofi Company, Framingham, MA USA 13:15 13:40 TBD Crina Balog, Janssen Infectious Diseases and Vaccines 13:40 14:05 TBD 14:05 14:30 TBD 14:30 15:00 Discussion 15:00 15:30 Technical Seminar Sponsored by Genedata GmbH Rechte Pirouette Room 11
Thursday, 17 March, 2016 15:30 16:00 Break Visit the Exhibits and Posters in the Linke Pirouette Room 16:00 16:25 TBD 16:25 16:50 TBD Higher Order Structure Session in Rechte Pirouette Room Session Chair: Andras Guttman, Northeastern University, Boston, MA USA 16:50 17:20 Discussion 17:20 18:20 Technical Seminar Sponsored by Waters Corporation Rechte Pirouette Room 19:00 22:00 Conference Event Location TBD 12
Friday, 18 March, 2016 08:30 12:00 Registration in the Salon Foyer Analysis of Aggregates Session in Rechte Pirouette Room Session Chair: Christof Finkler, F. Hoffmann-La Roche Ltd., Basel, Switzerland and Marta Germano, Janssen Infectious Diseases and Vaccines, Leiden, The Netherlands 09:00 09:25 Vaccine Product Characterization by AF4-MALS: Particle Size Distribution and Aggregation Martijn Schenning, Janssen Infectious Diseases and Vaccines, Leiden, The Netherlands 09:25 09:50 Impact of Non-Ideal Analyte Behavior on Separation of Proteins and Aggregates by AF4 Atana Koulov, F. Hoffmann La Roche Ltd., Basel, Switzerland 09:50 10:20 Discussion 10:20 10:50 Break - Visit the Exhibits and Posters in the Linke Pirouette Room Regulatory Session in Rechte Pirouette Room Session Chair: Birgit Schmauser, BfArM, Federal Institute for Drugs and Medical Devices, Cologne, Germany 10:50 11:15 Examples of Regulatory Expectations for Analytical Characterization and Testing Vicky Venizelos, Consultant 11:15 11:40 Applications of Mass Spectrometry to Streamline Product Characterization, Release and Stability Testing Juhong Liu, CDER, FDA, Silver Spring, MD USA 11:40 12:05 Expectations for Analytical Characterization in the Evaluation of Biosimilarity: A Regulator s Perspective Christian Mayer, Austrian Medicines and Medical Devices Agency, Vienna, Austria 12:05 12:35 Discussion 12:35 12:40 Closing Comments in Rechte Pirouette Room Cari Sänger - van de Griend, Kantisto BV, Baarn, The Netherlands 13