13th Symposium on the Practical Applications of Mass Spectrometry in the Industry (Mass Spec 2016)

Symposium Co-Chairs:

Eef Dirksen, Synthon B.V. Christopher Yu, Genentech, a Member of the Roche Group

September 27-30, 2016 The Westin San Diego San Diego, CA USA

Organized by

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Table of Contents

Student Travel Grants ......

Program, Exhibitor and Media Partners ......

Scientific Program Summary ......

Plenary and Session Abstracts ......

Roundtable Topics ......

Technical Seminar Abstracts ......

Poster Abstracts ......

2 Welcome to the 13th Symposium on the Practical Applications of Mass Spectrometry in the Biotechnology Industry

We are pleased to welcome you to the 13th 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 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, Analyst, Analytical Methods, Analytical Scientist, Biogen, Biognosys, BioProcess International, Bruker Daltonics, Inc., ChemComm, Chemical Science, ChemSocRev, CMP Scientific, Eurofins Lancaster Laboratories, Inc., Genetic Engineering & Biotechnology News, Genedata AG, Genentech, a Member of the Roche Group, Genovis AB, Green Chemistry, Integrative Biology, IPQ, LCGC, MedChemComm, The Medicine Maker, Molecular BioSystems, New England Biolabs, The Pathologist, Pfizer, Inc., Protein Metrics, ProZyme, Roche Diagnostics GmbH, Royal Society of Chemistry, 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 2016!

THE ORGANIZING COMMITTEE: Greg Adams, FUJIFILM Diosynth Vivian Lindo, MedImmune, A member of the AstraZeneca Group Alain Balland, Pharma Anders Lund, Genzyme, a Sanofi company GmbH & Co. KG Yelena Lyubarskaya, Codiak Biosciences Michael Boyne, BioTechLogic, Inc. Jun Park, CDER, FDA Patrick Bulau, Roche Diagnostics GmbH David Passmore, Bristol-Myers Squibb Company James Carroll, Pfizer, Inc. Jason Rouse, Pfizer, Inc. Steven Cohen, Northeastern University John Valliere-Douglass, Seattle Genetics, Inc. Eef Dirksen, Synthon Biopharmaceuticals B.V. Christopher Yu, Genentech, a Member of the (Co-chair) Roche Group (Co-chair)

3 CASSS Mass Spec 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 13th Symposium on the Practical Applications of Mass Spectrometry in the Biotechnology Industry (Mass Spec 2016). 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 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, higher- order 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:

Application of Quantitative Liquid Chromatography – Mass Spectrometry Techniques to Facilitate Enhanced Bioprocessing of Therapeutic Proteins Amy Farrell, NIBRT – The National Institute for Bioprocessing Research and Training, Ireland

Quantification of Serum Vitamin D Binding Protein by Novel LC-MS/MS Methodology Indicates Similar Concentrations in Blacks and Whites Clark Henderson, University of Washington, USA

Monitoring the Site-Specific Glycosylation, Site Occupancy and other PTMs in Plant Bioengineered Recombinant Therapeutical Glycoproteins John Muchena, University of California, Davis, USA

4 The Organizing Committee gratefully acknowledges the following strategic partners for their generous support of this Symposium: Strategic Program Partners

Platinum Program Partners AbbVie, Inc. Biogen

Gold Program Partner Pfizer, Inc.

Diamond Program Partner

Agilent Technologies

Platinum Program Partners

Bruker Daltonics, Inc. Genedata AG

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Gold Program Partners

Genentech, a Member of the Roche Group Roche Diagnostics GmbH SCIEX

Exhibitor Partners

908 Devices Agilent Technologies Biognosys Bruker Daltonics, Inc. CMP Scientific Eurofins Lancaster Laboratories, Inc. Genedata AG Genovis AB New England Biolabs Protein Metrics ProZyme SCIEX Thermo Fisher Scientific Waters Corporation

6 The Scientific Organizing Committee gratefully acknowledges the following media for their promotional consideration of Mass Spec 2016:

Media Program Partners

American Laboratory/labcompare American Pharmaceutical Review Analyst Analytical Methods The Analytical Scientist BioProcess International ChemComm Chemical Science ChemSocRev Genetic Engineering & Biotechnology News Green Chemistry Integrative Biology IPQ LCGC MedChemComm The Medicine Maker Molecular BioSystems The Pathologist Royal Society of Chemistry separationsNOW.com Technology Networks

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Mass Spec 2016 Scientific Program Summary

Tuesday, September 27, 2016

08:30 – 09:30 Breakfast (Full Day and Morning Short Course Attendees ONLY)

08:30 – 13:30 Short Course Registration ONLY in the Park Slope Foyer

Short Course in the Pearl Room Short Course Facilitator: Anders Lund, Genzyme, a Sanofi company, Framingham, MA USA

09:30 – 12:30 Fundamentals of Mass Spectrometry in the Analysis of Protein Therapeutics Anders Lund, Genzyme, a Sanofi company, Framingham, MA USA

12:30 – 13:30 Lunch (Full Day Short Course Attendees ONLY)

13:30 – 17:00 Applications of Mass Spectrometry to Characterize Protein Therapeutics Anders Lund, Genzyme, a Sanofi company, Framingham, MA USA

8 Wednesday, September 28, 2016

07:30 – 18:00 Registration in the Ballroom Foyer

07:30 – 08:30 Breakfast in Emerald Ballroom

08:30 – 08:45 Welcome and Introductory Comments in the Crystal Ballroom Christopher Yu, Genentech, a Member of the Roche Group, South San Francisco, CA USA

Keynote I Session in Crystal Ballroom Session Chair: Michael Boyne, BioTechLogic, Inc., Glenview, IL USA

08:45 – 09:45 Development and Applications of Ultraviolet Photodissociation Mass Spectrometry for Biological Problems Jennifer Brodbelt, University of Texas, Austin, TX USA

09:45 – 10:15 Break – Visit the Exhibits and Posters in Emerald Ballroom

ABC’s and XYZ’s of Sequencing Session in Crystal Ballroom Session Chairs: James Carroll, Pfizer, Inc. St. Louis, MO USA and Christopher Yu, Genentech, a Member of the Roche Group, South San Francisco, CA USA

10:15 – 10:45 TBD Jason Hogan, Bristol-Myers Squibb Company

10:45 – 11:15 Traditional de novo Sequencing Methodologies Applied to Biosimilar Product Development Jason Rouse, Pfizer, Inc., Andover, MA USA

11:15 – 11:45 Multiple Ion Activation Techniques for Improved Top-down and Middle-down Antibody Characterization Luca Fornelli, Northwestern University, Evanston, IL USA

11:45 – 12:00 Lunch for Technical Seminar Attendees – Please take lunch and return to Crystal Ballroom for the “Lunch and Learn”

12:00 – 12:30 Technical Seminar: Lunch and Learn

TBD

Sponsored by Genedata AG Crystal Ballroom

12:30 – 12:35 Mini Break for Technical Seminar Attendees

9 Wednesday, September 28, 2016, continued

12:35 – 13:05 Technical Seminar: Lunch and Learn

TBD

Sponsored by Bruker Daltonics Crystal Ballroom

13:05 – 13:20 Break - Visit the Exhibits and Posters in Emerald Ballroom

CE-MS Session in Crystal Ballroom Session Chairs: Steven Cohen, Northeastern University, Boston, MA USA and Steffen Kiessig, F. Hoffmann-La Roche Ltd, Basel, Switzerland

13:20 – 14:00 Microfabricated Technologies for the Analysis of Biopharmaceutical Materials J. Michael Ramsey, University of North Carolina, Chapel Hill, Chapel Hill, NC USA

14:00 – 14:30 Cutting-Edge Mass Spectrometry for mAbs & Related Product Structural Characterization Elsa Wagner-Rousset, Centre d'Immunologie Pierre Fabre, Saint Julien en Genevois, France

14:30 – 15:00 TBD Dan Rock, Amgen, Inc.

15:00 – 17:00 Poster Session I - Visit the Exhibits and Posters in Emerald Ballroom

17:00 – 18:00 Round Table Discussions - TBD

18:00 – 19:00 Welcome Reception - TBD

10 Thursday, September 29, 2016

08:00 – 17:00 Registration in the Ballroom Foyer

07:30 – 08:30 Breakfast in Emerald Ballroom

Novel Technologies, Product and Process Characterization Session in Crystal Ballroom Session Chairs: David Passmore, Bristol-Myers Squibb Company, Redwood City, CA USA and Jason Rouse, Pfizer, Inc., Andover, MA USA

08:30 – 09:00 Measuring the Quality of Immunization-induced Immune Responses using Hydrogen/Deuterium Exchange Mass Spectrometry Lee Frego, Boehringer Ingelheim Pharma GmbH & Co. KG, Ridgefield, CT, USA

09:00 – 09:30 Performance of a Chip-based CE-MS Interface for Biotherapeutic Characterization: Evaluation and Applications Justin Sperry, Pfizer, Inc., Chesterfield, MO USA

09:30 – 10:00 Ion Mobility-Mass Spectrometry and Collision Induced Unfolding Rapidly Detect Subtle Differences in Antibody Glycoforms Yuwei Tian, University of Michigan, Ann Arbor, MI USA

10:00 – 10:30 Break - Visit the Exhibits and Posters in Emerald Ballroom

10:30 – 11:00 LC/MS Analysis of AAV Viral Capsid Proteins for Research and Development Xiaoying Jin, Genzyme, a Sanofi company, Framingham, MA USA

11:00 – 11:30 Simultaneous Monitoring of Multi-Attributes for Product Attribute Control (PAC) by Mass Spec Based Method Yi Wang, Merck & Co., Inc., Kenilworth, NJ USA

11:30 – 11:45 Lunch for Technical Seminar Attendees – Please take lunch and return to Crystal Ballroom for the “Lunch and Learn”

11:45 – 12:15 Technical Seminar: Lunch and Learn

TBD

Sponsored by Agilent Technologies Crystal Ballroom

12:15 – 12:20 Mini Break for Technical Seminar Attendees

11 Thursday, September 29, 2016, continued

12:20 – 12:50 Technical Seminar: Lunch and Learn

TBD

Sponsored by SCIEX Crystal Ballroom

12:50 – 14:50 Poster Session II - Visit the Exhibits and Posters in Emerald Ballroom

Young Scientist Session in Crystal Ballroom Session Chairs: Alain Balland, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riss, Germany and Patrick Bulau, Roche Diagnostics GmbH, Penzberg, Germany

14:50 – 15:10 Rapid Characterization of Biotherapeutic Proteins by Size-exclusion Chromatography Coupled to Native Mass Spectrometry Anna-Katharina Heidenreich, Roche Diagnostics GmbH, Penzberg, Germany

15:10 – 15:30 TBD

15:30 – 15:50 LC-MS/MS Approach to Amino Acid Misincorporation Detection for Monoclonal Antibodies Benjamin Moore, Genentech, a Member of the Roche Group, South San Francisco, CA USA

15:50 – 17:00 Exhibitor Reception - Visit the Exhibits in Emerald Ballroom

12 Friday, September 30, 2016

08:00 – 14:00 Registration in the Ballroom Foyer

07:30 – 08:30 Breakfast in Emerald Ballroom

Regulatory Session in Crystal Ballroom Session Chair: John Valliere-Douglass, Seattle Genetics, Inc., Bothell, WA USA and Anders Lunch, Genzyme, a Sanofi Company, Framingham, MA USA

08:30 – 09:00 Measuring the Quality of Immunization-induced Immune Responses using Hydrogen/Deuterium Exchange Mass Spectrometry Violet Lee, Genentech, a Member of the Roche Group, South San Francisco, CA USA

09:00 – 09:30 Influencing Early-stage Process Development with Peptide Mapping Catherine Eakin, Seattle Genetics, Inc., Bothell, WA USA

09:30 – 10:00 Break - Visit the Exhibits and Posters in Emerald Ballroom

10:00 – 10:30 TBD

10:30 – 11:00 Opportunities and Challenges in Applying LC-MS Multi-Attribute Method (MAM) to Biopharmaceutical Release Li Zang, Biogen, Cambridge, MA USA

10:00 – 11:30 Panel Discussion

11:30 – 11:45 Lunch for Technical Seminar Attendees – Please take lunch and return to Crystal Ballroom for the “Lunch and Learn”

11:45 – 12:15 Technical Seminar: Lunch and Learn

TBD

Sponsored by Protein Metrics Crystal Ballroom

12:15 – 12:20 Mini Break for Technical Seminar Attendees

12:20 – 12:50 Technical Seminar: Lunch and Learn

TBD

Sponsored by Waters Corporation Crystal Ballroom

13 Friday, September 30, 2016, continued

12:50 – 13:05 Break - Visit the Exhibits and Posters in Emerald Ballroom

Bioanalytical Session in Crystal Ballroom Session Chairs: Eef Dirksen, Synthon Biopharmaceuticals B.V., Nijmegen, Netherlands and Vivian Lindo, MedImmune, A member of the Astra Zeneca Group, Cambridge, UK

13:05 – 13:35 Bioanalytical Strategies for the Quantitation of in vivo Site Specific Modifications of Therapeutic Antibodies in Early Discovery Cyno Studies using IP-LC-MS Celia D’Arienzo, Bristol-Myers Squibb Company

13:35 – 14:05 TBD Brooke Rock, Amgen, Inc.

14:05 – 14:35 TBD

14:35 – 14:40 Poster Award Announcement in Crystal Ballroom

14:40 – 14:50 Closing Comments in Crystal Ballroom Eef Dirksen, Synthon Biopharmaceuticals B.V., Nijmegen, Netherlands

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