12th Symposium on the Practical Applications of Mass Spectrometry in the Biotechnology Industry (Mass Spec 2015)

Transcription

1 12th Symposium on the Practical Applications of Mass Spectrometry in the Biotechnology Industry (Mass Spec 2015) Symposium Co-Chairs: Steven Cohen, Northeastern University Christopher Yu, Genentech, a Member of the Roche Group September 23-25, 2015 New York Marriott at Brooklyn Bridge Brooklyn, NY USA Organized by 1

2 Table of Contents Student Travel Grants... Program, Exhibitor and Media Partners... Scientific Final Program Summary... Plenary and Session Abstracts... Workshop... Technical Seminar Abstracts... Poster Abstracts... 2

3 Welcome to the 12th Symposium on the Practical Applications of Mass Spectrometry in the Biotechnology Industry We are pleased to welcome you to the 12th Symposium on the Practical Application of Mass Spectrometry in the Biotechnology Industry. The focus of this Symposium is the application of mass spectrometry for product characterization, process monitoring, formulation development and release testing in the pharmaceutical industry. Since mass spectrometry is a critical technology 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. The symposium will feature a diversified selection of speakers from academia, industry and regulatory agencies, who will discuss applications of state-of-the-art mass spectrometry to proteins, glycans, nucleic acids, viral vectors and other molecules of therapeutic interest. The success of this symposium will depend not only on our experienced and knowledgeable speakers and workshop 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 that have been designed to stimulate 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 AbbVie, Inc., Agilent Technologies, Analytical Scientist, Biogen, Bio Tech International, BioProcess International, Bruker Daltonics, Inc., CMP Scientific, Eurofins Lancaster Laboratories, Inc., Genetic Engineering & Biotechnology News, Genedata AG, Genovis AB, IPQ, LCGC North America, Medicine Maker, New England Biolabs Inc., Pathologist, Pfizer, Inc., Protein Metrics, ProZyme, Inc., Roche Diagnostics GmbH & Genentech, a Member of the Roche Group, RSC Advances, separationsnow.com, SCIEX, Technology Networks Limited, Thermo 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 2015! THE ORGANIZING COMMITTEE: Greg Adams, FUJIFILM Diosynth Biotechnologies Alain Balland, Boehringer Ingelheim Pharma GmbH & Co. KG Michael Boyne, BioTechLogic, Inc. Patrick Bulau, Roche Diagnostics GmbH James Carroll, Pfizer, Inc. Steven Cohen, Northeastern University, (Co-chair) Eef Dirksen, Synthon Biopharmaceuticals B.V. Vivian Lindo, MedImmune, A member of the AstraZeneca Group Anders Lund, Genzyme, a Sanofi company Yelena Lyubarskaya, Biogen Jun Park, CDER, FDA David Passmore, Bristol-Myers Squibb Jason Rouse, Pfizer, Inc. Hansjörg Toll, Sandoz GmbH Christopher Yu, Genetech, a Member of the Roche Group (Co-chair) 3

4 CASSS Mass Spec Student Travel Grants CASSS is pleased to provide a limited number of student travel grants for PhD students and postdocs who present applicable posters at the 12th Symposium on the Practical Applications of Mass Spectrometry in the Biotechnology Industry (Mass Spec 2015). PhD students or postdoctoral 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. Applications will highlight uses of MS in various areas of product development including lead selection & optimization, high throughput screening, identification of PTMs, process development and in-process testing, drug product characterization, higherorder structure, and adoption of innovative MS technologies. Participants will have an excellent opportunity to meet, network and participate in exchanging knowledge for mutual education with other MS practitioners. 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: P-166_T Protein-Protein Interactions: Protein Footprinting and Mass Spectrometry Map the Interface of Marburg virus VP24 interacting with Keap1 Jing Li, University of Washington in St. Louis, USA Thursday, September 24 Young Scientist Session High Resolution Accurate Mass LC-MS/MS based Characterization of Industrial Cell Culture Media to Identify Compound Signatures of Process Variability Brian Morrissey, NIBRT - The National Institute for Bioprocessing Research and Training, Ireland P-167-F Intact Monoclonal Antibody Analysis via Microchip CE-MS Erin A. Redman, University of North Carolina, Chapel Hill, USA P-168-T Comprehensive Characterization of Human Growth Hormone Degradants by Integration of a Top-down and Bottom Mass Spectrometry Approach Annie Yu Wang, The Barnett Institute, Northeastern University, USA 4

5 The Organizing Committee gratefully acknowledges the following program partners for their generous support of this Symposium: Sustaining Program Partners Platinum Program Partners AbbVie, inc. Biogen Silver Program Partner Pfizer, Inc. Diamond Program Partner Agilent Technologies Platinum Program Partner Bruker Daltonics Genedata AG Gold Program Partners Roche Diagnostics GmbH & Genentech, a Member of the Roche Group SCIEX 5

6 Welcome Reception Bruker Daltonics Exhibitor Partners Agilent Technologies Bruker Daltonics, Inc. CMP Scientific Eurofins Lancaster Laboratories, Inc. Genedata AG Genovis AB New England BioLabs Inc. Protein Metrics ProZyme, Inc. SCIEX Thermo Scientific Waters Corporation 6

7 Media Program Partners Analytical Scientist Bio Tech International BioProcess International Genetic Engineering & Biotechnology News IPQ LCGC North America Medicine Maker Pathologist RSC Advances separationsnow.com Technology Networks Limited Supporting Organizations Chicago Mass Spectrometry Discussion Group Connecticut Mass Spectrometry Discussion Group Dutch Society for Mass Spectrometry German Society for Mass Spectrometry Greater Boston Mass Spectrometry Discussion Group MASSEP.org, A Separation Science Discussion Group Midwest Mass Spectrometry Discussion Group Pharmaceutical & Bioscience Society (PBSS) International Scripps Center for Metabolomics and Mass Spectrometry (SANDMAN) Washington-Baltimore Mass Spectrometry Discussion Group 7

8 Mass Spec 2015 Scientific Program Summary Tuesday, September 22, :30 08:30 Breakfast (Full Day and Morning Short Course Attendees ONLY) 08:00 13:30 Short Course Registration ONLY in the Louis M. Martini and Trefethen Foyer Short Course in the Park Slope Room Session Chair: Anders Lund, Genzyme, a Sanofi company, Framingham, MA USA 08:30 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) 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 23, :00 18:00 Registration in the Ballroom Foyer 07:30 08:30 Breakfast in the Ballroom A-C 13:00 13:15 Welcome and Introductory Comments in the Ballroom D Steve Cohen, Northeastern University, Boston, MA USA Plenary I Session in Ballroom D Session Chair: Jason Rouse, Pfizer, Inc. Andover, MA, USA 13:15 14:15 Ultrahigh Resolution Mass Spectrometry: Extending the Size and Detail of Biomolecule Structure Analysis Alan Marshall, Florida State University, Tallahassee, FL USA 14:15 14:45 Break Visit the Exhibits and Posters in Ballroom A-C Process and Product Characterization Session in Ballroom D Session Chairs: Alain Balland, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riss, Germany and Christopher Yu, Genentech, A Member of the Roche Group 14:45 15:15 Minimizing Trisulfides in Monoclonal Antibodies: Early Screening and Detection using Ultrahigh-Resolution Mass Spectrometry to Ensure Product Quality and Consistency Lisa Marzilli, Pfizer, Inc., Andover, MA USA 15:15 15:45 Application of Mass Spectrometry for Process Understanding and Advanced Process Control Kazumi Kobayashi, Biogen, Cambridge, MA USA 15:45 16:15 Implementing a LC/MS Based Multi-Attribute Method in GMP Environment Da Ren, Amgen Inc., Thousand Oaks, CA USA 16:15 16:30 The Application of High Resolution Top Down Mass Spectrometry to the Study of Degradation Reactions in Stability Samples of Protein Pharmaceutical Jeffrey Agar, Northeastern University, Boston, MA USA 9

10 Wednesday, September 23, 2015 continued 16:30 17:30 Technical Seminar Breakthrough Applications to Expand and Speed Biopharmaceutical Characterization Bryan Fonslow, SCIEX, Brea, CA USA Sponsored by SCIEX Ballroom D 17:30 19:00 Welcome Reception Hosted by Bruker Daltonics Location TBD 10

11 Thursday, September 24, :30 17:30 Registration in the Ballroom Foyer 07:30 08:30 Breakfast in Ballroom A-C 07:30 08:30 Technical Seminar Sponsored by Protein Metrics Ballroom D Plenary II Session in Ballroom A-C Session Chair: Steven Cohen, Northeastern University, Boston, MA USA 08:30 09:30 Innovative Instrumentation and Methods for Sequence Analysis of Antibodies and Posttranslationally-modified, Intact Proteins on a Chromatographic Time-scale Donald Hunt, University of Virginia, Charlottesville, VA USA 09:30 10:00 Break Visit the Exhibits and Posters in Ballroom A-C 10:00 11:00 Workshop I in Ballroom A-C Workshop Chair: Jason Rouse, Pfizer, Inc., Andover, MA USA Host Cell Proteins and Other Process Related Impurities Session in Ballroom D Session Chair: Patrick Bulau, Roche Diagnostics GmbH, Penzberg, Germany and Steven Cohen, Northeastern University, Boston, MA USA 11:00 11:30 Novel Approaches to Targeted Protein Analysis using LC-MRM in an HSV2 Vaccine Candidate Andrew James, Sanofi Pasteur Ltd., Toronto, ON Canada 11:30 12:00 An Accelerated LC-MS/MS Workflow for Assessment of the Host Cell Protein Composition during Biotherapeutic Process Development Don Walker, Genentech, A Member of the Roche Group, South San Francisco, CA USA 12:00 12:15 Break Please Take Lunch and Return to Ballroom D for Lunch and Learn 12:15 13:15 Technical Seminar: Lunch and Learn Sponsored by Agilent Technologies Ballroom D 11

12 Thursday, September 24, 2015 continued 13:15 13:30 Break - Visit the Exhibits and Posters in Ballroom A-C Young Scientist Session in Ballroom D Session Chair: James Carroll, Pfizer, Inc. St. Louis, MO USA 13:30 13:45 Impact of Sequence Variants on the HOS Analysis of Monoclonal Antibodies using an Optimized HDX-MS Method with Two Protease Column Approach Sasidhar Nirudodhi, Pfizer, Inc., Chesterfield, MO USA 13:45 14:00 High Resolution Accurate Mass LC-MS/MS Based Characterization of Industrial Cell Culture Media to Identify Compound Signatures of Process Variability Brian Morrissey, NIBRT, Dublin, Ireland 14:00 14:15 LC-MS Based Determination of Critical Attributes of a Novel Antibody-Drug Conjugate (ADC) Srikanth Kotapati, Bristol-Myers Squibb, Redwood City, CA USA 14:15 15:45 Poster Session I - Visit the Exhibits and Posters in Ballroom A-C Mass Spec Approaches for Quantitative Studies Session in Ballroom D Session Chair: Eef Dirksen, Synthon Biopharmaceuticals B.V., Nijmegen, The Netherlands and Vivian Lindo, MedImmune, A member of the AstraZeneca Group, Cambridge, United Kingdom 15:45 16:15 Data Analysis Strategies for Detecting and Characterizing Unknown Chemical and Posttranslational Modifications on Proteins John Valliere-Douglas, Seattle Genetics, Bothell, WA USA 16:15 16:45 Functional Assessment of Antibody Oxidation by Native Mass Spectrometry Markus Haberger, Roche Diagnostics GmbH, Penzberg, Germany 16:45 17:15 Understanding of Critical Quality Attributes of Biopharmaceuticals In Vivo Yinyin Li, Biogen, Cambridge, MA USA 17:15 18:15 Exhibitor Reception - Visit the Exhibits and Posters in Ballroom A-C 12

13 Friday, September 25, :30 17:00 Registration in the Ballroom Foyer 07:30 08:30 Breakfast in Ballroom A-C 07:30 08:30 Technical Seminar Routine and Advanced Comparability Studies for the Next Generation of Innovators and Biosimilars Asish Chakraborty, Waters Corporation, Milford, MA USA Sponsored by Waters Corporation Ballroom D Plenary III Session in Ballroom D Session Chair: Yelena Lyubarskaya, Biogen, Cambridge, MA USA 08:30 09:30 Rapid Production of Versatile Nanobody Repertoires Brian Chait, Rockefeller University, New York, NY USA 09:30 10:00 Break Visit the Exhibits and Posters in Ballroom A-C Regulatory Session in Ballroom D Session Chair: Michael Boyne, BioTechLogic, Inc., Glenview, IL USA 10:00 10:30 Characterization of Filgrastim using Intact and Top-down MS Johann Holzmann, Sandoz GmbH, Kundl, Austria 10:30 11:00 Applications of MS in Biosimilar Product Development and Similarity Assessment Jennifer Liu, Amgen Inc., Thousand Oaks, CA USA 11:00 11:30 The Use of Mass Spectrometry in FDA Applications for Biotherapeutics: A Retrospective Review Sarah Rogstad, CDER, FDA, Silver Spring, MD USA 11:30 12:30 Panel Discussion 12:30 12:45 Break Please Take Lunch and Return to Ballroom D for Lunch and Learn 13

14 Friday, September 25, 2015 continued 12:45 13:45 Technical Seminar: Lunch and Learn Unbiased in Depth Characterization of CEX-fractions from a Stressed Mab by MS Matthias Berg, Novartis Pharma, Basel, Switzerland Sponsored by Genedata AG Ballroom D 13:45 15:00 Poster Session II - Visit the Exhibits and Posters in Ballroom A-C Novel Technologies Session in the Ballroom D Session Chair: David Passmore, Bristol-Myers Squibb Company, Redwood City, CA USA 15:00 15:30 Mass Spectrometry Assisted Development of an Efficient In-silico Prediction Tool for Aspartate Degradation Sites Hans Rainer Voelger, Roche Diagnostics GmbH, Penzberg, Germany 15:30 16:00 Utility of Ion-Mobility Mass Spectrometry in Antibody Drug Conjugates Characterization Richard Huang, Bristol-Myers Squibb, Princeton, NJ USA 16:00 16:30 In-depth, Quantitative (Host Cell) Protein Fingerprinting of Adenovirus Based Vaccines by Mass Spectrometry Annemiek Verwilligen, Janssen Infectious Diseases and Vaccines, Leiden, The Netherlands 16:30 16:45 Poster Award Announcement in Ballroom D 16:45 16:55 Closing Comments in Ballroom D Christopher Yu, Genentech, a Member of the Roche Group, South San Francisco, CA USA 14