Analytical Technologies Europe: Symposium on the Practical Applications including CE, LC and MS in the Biopharmaceutical Industry (AT Europe 2016)

Transcription

1 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 March, 2016 Imperial Riding School Renaissance Hotel Vienna, Austria Organized by

2 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

3 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

4 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

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 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

6 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

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 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

8 AT Europe 2016 Scientific Final Program Summary Tuesday, 15 March, :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

9 08:30 18:00 Registration in the Foyer Wednesday, 16 March, :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

10 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

11 Thursday, 17 March, :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

12 Thursday, 17 March, :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

13 Friday, 18 March, :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