14th Symposium on the Practical Applications of Mass Spectrometry in the Biotechnology Industry (Mass Spec 2017)

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1 14th Symposium on the Practical Applications of Mass Spectrometry in the Biotechnology Industry (Mass Spec 2017) Symposium Co-Chairs: Michael Boyne, BioTechLogic, Inc. Eef Dirksen, Synthon Biopharmaceuticals B.V. September 19-22, 2017 Boston Park Plaza Hotel Boston, MA USA Organized by

2 Table of Contents Welcome Letter... Student Travel Grants... Program, Exhibitor and Media Partners... Scientific Program Summary... Plenary and Session Abstracts... Roundtable Discussion Topics... Technical Seminar Abstracts... Poster Abstracts... 2

3 Welcome to the 14th Symposium on the Practical Applications of Mass Spectrometry in the Biotechnology Industry We are pleased to welcome you to the 14th Symposium on the Practical Application of Mass Spectrometry in the Biotechnology Industry. The focus of this Symposium is the application of mass spectrometry (MS) for product characterization, process monitoring, formulation development and release testing in the pharmaceutical industry. Since mass spectrometry is used routinely for a wide array of applications, the meeting will provide scientists in the industry an opportunity to share their data and learn from their colleagues. Although most of the applications may deal with biopharmaceuticals (proteins, DNA, viral vectors), applications for conventional pharmaceuticals will also be discussed. The Symposium will be held over a period of two and a half days devoted to practical concerns in the use of MS within the biotechnology and pharmaceutical industries. The success of this symposium will depend not only on our experienced and knowledgeable speakers and leaders but also on the interactions and open discussion that take place among the attendees. We encourage you to participate wholeheartedly in the discussion sections and Roundtable sessions that have been designed to stimulate the exchange of ideas and information. We would like to thank the speakers who are giving generously of their time and resources, and you for your attendance, which will make this a successful endeavor. We gratefully acknowledge the generosity of our sponsors and exhibitors. Thank you to 908 Devices, AbbVie, Inc., Agilent Technologies, American Laboratory/labcompare, American Pharmaceutical Review, The Analytical Scientist, Biogen, BioProcess International, Bruker Daltonics, Inc., Charles River Laboratories, Inc., CMP Scientific, Corp., Eli Lilly and Company, Eurofins Lancaster Laboratories, Inc., Genetic Engineering & Biotechnology News, Genedata AG, Genentech, a Member of the Roche Group, Genovis AB, International Pharmaceutical Quality, LCGC, New England Biolabs, The Pathologist, Pfizer, Inc., Pharmaceutical Outsourcing, Promega Corporation, Protein Metrics, Inc., ProZyme, Roche Diagnostics GmbH, Sanofi, separationsnow.com, SCIEX, Technology Networks, Thermo Fisher Scientific and Waters Corporation. We are also thankful for the expert assistance and support of Renee Olson and CASSS, as well as the audiovisual expertise of Michael Johnstone from MJ Audio-Visual Productions. We hope you enjoy the conference, build new contacts and return for new information in 2018! THE ORGANIZING COMMITTEE: Greg Adams, FUJIFILM Diosynth Biotechnologies Michael Boyne*, BioTechLogic, Inc. Steven Cohen, SAC Analytical Consultants Terry Cyr, Health Canada Eef Dirksen*, Synthon Biopharmaceuticals B.V. Anders Lund, Genzyme, a Sanofi company Yelena Lyubarskaya, Codiak Biosciences *Symposium Co-chair Jun Park, CDER, FDA David Passmore, Bristol-Myers Squibb Company Rich Rogers, Just. Biotherapeutics Jason Rouse, Pfizer, Inc. Arjen Scholten, Janssen Infections Diseases and Vaccines John Valliere-Douglass, Seattle Genetics, Inc. Christopher Yu, Genentech, a Member of the Roche Group 3

4 CASSS Mass Spec Student Travel Grants CASSS is pleased to provide a limited number of student travel grants for PhD students and postdoctoral fellows who present applicable posters at the 14th Symposium on the Practical Applications of Mass Spectrometry in the Biotechnology Industry (Mass Spec 2017). PhD students or post-doctoral fellows conducting research at academic institutions throughout the world are eligible. This symposium offers insight to current topics and issues under discussion within the biotech and biopharmaceutical industries, and as such, provides an opportunity to bridge between industry, academia, and regulatory agencies. The presentations and workshops are focused on the application of mass spectrometry to advance drug discovery and development in the biotechnology industry. Topics will include the utility of MS as an alternative to conventional assays such as peptide mapping, ion exchange, capillary electrophoresis, as well as for the analysis of process-related impurities, such as host cell proteins; introduction of MS in the QC laboratory, validation/transfer/compliance strategy, system suitability/assay acceptance criteria; expectations from regulatory agencies for MS based assays for product characterization, release and stability; technical challenges regarding quantitation, ionization, higher order structure analysis, etc.; applications of MS for high throughput screening of cell-lines, raw materials, inprocess samples; and benchmarking of new technology. Requirements are: - Present a poster on a MS topic - Proof of studentship/post-doc status - Recommendation from the supervisor/advisor This year s grant winners include: A Novel Method for On-line Native MS Analysis of Monoclonal Antibody Charge Variants Applying Volatile Buffers in SCX Chromatography Florian Füssl, NIBRT, Co Dublin, Ireland Glycomic and Glycoproteomic Analysis of Biopharmaceuticals in a High Throughput and Highly Sensitive Manner Guinevere Kammeijer, Leiden University Medical Center, Leiden, Netherlands Native Mass Spectrometry for the Revelation of Highly Complex Glycosylation Patterns in Biopharmaceuticals Therese Wohlschlager, University of Salzburg, Salzburg, Austria 4

5 The Organizing Committee gratefully acknowledges the following program partners for their generous support of this Symposium Strategic Program Partners Platinum Program Partners AbbVie, Inc. Biogen Gold Program Partner Eli Lilly and Company Pfizer, Inc. Platinum Program Partners Bruker Daltonics, Inc. Genedata AG Gold Program Partners Agilent Technologies Genentech, a Member of the Roche Group Roche Diagnostics GmbH SCIEX Bronze Program Partner Sanofi 5

6 Exhibitor Partners 908 Devices Agilent Technologies Bruker Daltonics, Inc. Charles River Laboratories International, Inc. CMP Scientific, Corp. Eurofins Lancaster Laboratories, Inc. Genedata AG Genovis AB New England Biolabs Promega Corporation Protein Metrics Inc. ProZyme SCIEX Thermo Fisher Scientific Waters Corporation 6

7 The Organizing Committee gratefully acknowledges the following media for their promotional consideration of Mass Spec 2017 Media Program Partners American Laboratory/labcompare American Pharmaceutical Review The Analytical Scientist BioProcess International Genetic Engineering & Biotechnology News International Pharmaceutical Quality LCGC The Pathologist Pharmaceutical Outsourcing separationsnow.com Technology Networks 7

8 Mass Spec 2017 Scientific Program Summary Tuesday, September 19, :30 09:30 Breakfast (Full Day Short Course Attendees ONLY) in the Berkeley Ballroom 08:30 13:30 Short Course Registration ONLY in the Ballroom Foyer Short Course in the Clarendon Ballroom Short Course Instructor: Anders Lund, Genzyme, a Sanofi company, Framingham, MA USA 09:00 12:00 Fundamentals of Mass Spectrometry in the Analysis of Protein Therapeutics Anders Lund, Genzyme, a Sanofi company, Framingham, MA USA 12:00 13:00 Lunch (Full Day Short Course Attendees ONLY) in the Berkeley Ballroom 13:00 17:00 Applications of Mass Spectrometry to Characterize Protein Therapeutics Anders Lund, Genzyme, a Sanofi company, Framingham, MA USA 8

9 Wednesday, September 20, 2017 User Group Meetings (By Invitation Only/Must Preregister Online) 08:30 11:30 Thermo Fisher Scientific User Group in the Clarendon Ballroom 08:30 11:30 Waters Corporation User Group in the Arlington Ballroom 09:30 12:00 Protein Metrics Inc. User Group in the Berkeley Ballroom Mass Spec 2017 Scientific Program 12:00 17:15 Registration for Mass Spec 2017 in the Ballroom Foyer 13:00 13:15 Welcome and Introductory Comments in the Georgian Room Eef Dirksen, Synthon Biopharmaceuticals B.V., Nijmegen, Netherlands Keynote I Session in the Georgian Room Session Chair: Jason Rouse, Pfizer, Inc., Andover, MA USA 13:15 14:15 TBD Nathalie Agar, Harvard Medical School, Boston, MA USA 14:15 14:45 Break Visit the Exhibits and Posters in the Terrace Room Process and Product Characterization Session in the Georgian Room Session Chairs: David Passmore, Redwood City, CA USA and John Valliere-Douglass, Seattle Genetics, Inc., Bothell, WA USA 14:45 15:15 A Mass Spectrometry Approach for the Screening of Cell Culture Raw Materials and Spent Media Rachel Chen, Biogen, Cambridge, MA USA 15:15 15:45 ELISA Reagent Coverage Evaluation by Affinity Purification Tandem Mass Spectrometry Scott Henry, Seattle Genetics, Inc., Bothell, WA USA 15:45 16:15 A Platform Disulfide Mapping Method for Characterization of Therapeutic Proteins with Various Formats Bing Zhang, Genentech, a Member of the Roche Group, South San Francisco, CA USA 9

10 Wednesday, September 20, 2017, continued 16:15 17:15 Roundtable Discussion Session I in Arlington/Berkeley/Clarendon 17:15 18:45 Welcome Reception in TBD 10

11 Thursday, September 21, :00 17:20 Registration in the Ballroom Foyer 07:30 08:30 Breakfast in the Terrace Room 07:30 08:30 Job Board Live! Breakfast in Arlington/Berkeley/Clarendon Bioanalytical Session in the Georgian Room Session Chair: Eef Dirksen, Synthon Biopharmaceuticals B.V., Nijmegen, Netherlands 08:30 09:00 Paving the Way for Assessing in vivo Dynamics of Multiple Quality Attributes for Protein Therapeutics Haihong Zhou, Merck &Co., Inc., Kenilworth, NY USA 09:00 09:30 Characterizing the Immune Response to Novel Vaccine Candidates in a Human Whole Blood Assay Using Hight-dimensional Single Cell Proteomics Andrew James, Sanofi Pasteur, Toronto, ON Canada 09:30 10:00 TBD David Roos, Boehringer Ingelheim 10:00 10:30 Break - Visit the Exhibits and Posters in the Terrace Room Emerging Product Areas Session in the Georgian Room Session Chairs: Jun Park, Silver Spring, MD USA and Christopher Yu, Genentech, a Member of the Roche Group, South San Francisco, CA USA 10:30 11:00 Studying the Structure of Carbohydrates in Order to Better Understand Bacterial Vaccines and Pathogens John Cipollo, CBER, FDA 11:00 11:30 Quantification of Membrane Proteins in Genetically Engineered Crops by Liquid Chromatography Coupled with Tandem Mass Spectrometry Lindsey Schacherer, DuPont Pioneer, Johnston, IA USA 11:30 12:00 Assessment of Monoclonal Antibody-Fc Receptor Interactions by Online SEC-Native Mass Spectrometry Hongxia Wang, Regeneron Pharmaceuticals, Inc., Tarrytown, NY USA 10:00 10:30 Break - Visit the Exhibits and Posters in the Terrace Room 11

12 Thursday, September 21, 2017, continued 12:00 12:15 Lunch for Technical Seminar Attendees Please take lunch and return to the Georgian Ballroom for the Lunch and Learn 12:15 12:45 Technical Seminar: Lunch and Learn TBD TBD, TBD Sponsored by Genedata AG Georgian Ballroom 12:45 12:50 Mini Break for Technical Seminar Attendees 12:50 13:20 Technical Seminar: Lunch and Learn TBD TBD, TBD Sponsored by Bruker Daltonics, Inc. Georgian Ballroom 13:20 15:20 Poster Session I - Visit the Posters in the Terrace Room Young Scientist Session in the Georgian Room Session Chair: Steve Cohen, SAC Analytical Consultants, Hopkinton, MA USA 15:20 15:40 Native Size Exclusion Chromatography Coupled with Multi-Angle and Dynamic Light Scattering and Mass Spectrometry for Heightened Characterization of High Molecular Mass Species in Monoclonal Antibodies Ying Zhang, Pfizer, Inc., Andover, MA USA 15:40 16:00 Glycomic and Glycoproteomic Analysis of Biopharmaceuticals in a High Throughput and Highly Sensitive Manner Guinevere Kammeijer, Leiden University Medical Center, Leiden, Netherlands 16:00 16:20 A Novel Method for On-line Native MS Analysis of Monoclonal Antibody Charge Variants Applying Volatile Buffers in SCX Chromatography Florian Füssl, NIBRT, Co Dublin, Ireland 16:20 17:20 Roundtable Discussion Session II in Arlington/Berkeley/Clarendon 17:20 18:20 Exhibitor Reception - Visit the Exhibits in the Terrace Room 12

13 Friday, September 22, :00 16:50 Registration in the Ballroom Foyer 07:30 08:30 Breakfast in the Terrace Room Keynote II Session in the Georgian Room Session Chair: Michael Boyne, BioTechLogic, Inc., Glenview, IL USA 08:30 09:30 Charge Detection Mass Spectrometry: Weighing Heavier Things Martin Jarrold, Indiana University, Bloomington, IN USA 09:30 10:00 Break - Visit the Exhibits and Posters in the Terrace Room Viral Capsid Proteins Session in the Georgian Room Session Chairs: Yelena Lyubarskaya, Genzyme, A Sanofi Company, Westborough, MA USA and Arjen Scholten, Janssen Infectious Diseases and Vaccines, Leiden, Netherlands 10:00 10:30 A Mass Spectrometry Based ELISA Assay for Adenovirus Vaccine Potency Testing Jonathan Knibbe, Janssen Infectious Diseases and Vaccines, Leiden, Netherlands 10:30 11:00 Pushing the Boundaries of Adenovirus Characterization: Development and Application of LC-MS Methods for Comprehensive Understanding of Adenovirus Capsid Thomas Powers, Pfizer, Inc., Chesterfield, MO USA 11:00 11:30 Human HEK293 and Baculovirus-Insect Sf9 Manufacturing Platforms Generate Chemically and Functionally Distinct AAV Vectors Nicole Paulk, Stanford University School of Medicine, Stanford, CA USA 11:30 11:45 Lunch for Technical Seminar Attendees Please take lunch and return to the Georgian Room for the Lunch and Learn 11:45 12:15 Technical Seminar: Lunch and Learn TBD TBD, TBD Sponsored by SCIEX Georgian Ballroom 12:15 12:20 Mini Break for Technical Seminar Attendees 13

14 Friday, September 22, 2017, continued 12:20 12:50 Technical Seminar: Lunch and Learn TBD TBD, TBD Sponsored by Agilent Technologies Georgian Ballroom 12:50 14:20 Poster Session II - Visit the Posters in the Terrace Room CMC Strategy and the Use of Mass Spec Session in the Georgian Room Session Chairs: Anders Lund, Genzyme, A Sanofi Company, Framingham MA USA and Richard Rogers, Just Biotherapeutics, Seattle, WA USA 14:20 14:50 Monitoring Biologics cqas for Quality Control Using MAM Michael Olma, MSD, Schachen, Switzerland 14:50 15:20 Analysis of Biopharmaceutical Attributes of in a GMP Setting Yan Jiang, Sanofi, Framingham, MA USA 15:20 15:50 TBD TBD, TBD 15:50 16:20 Panel Discussion 16:20 16:30 Poster Award Announcement in the Georgian Room 16:30 16:45 Closing Comments in the Georgian Room Michael Boyne, BioTechLogic, Inc., Glenview, IL USA 14

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