6Th Symposium on the Practical Applications of Mass
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13th Symposium on the Practical Applications of Mass Spectrometry in the Biotechnology Industry (Mass Spec 2016) Symposium Co-Chairs: Eef Dirksen, Synthon Biopharmaceuticals 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 1 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 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, 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, The Pathologist, Pfizer, Inc., Protein Metrics, Roche Diagnostics GmbH, Royal Society of Chemistry, separationsNOW.com, SCIEX, Technology Networks 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 Anders Lund, Genzyme, a Sanofi company Biotechnologies Yelena Lyubarskaya, Codiak Biosciences Alain Balland, Boehringer Ingelheim Pharma Jun Park, CDER, FDA GmbH & Co. KG David Passmore, Bristol-Myers Squibb Company Michael Boyne, BioTechLogic, Inc. Jason Rouse, Pfizer, Inc. Patrick Bulau, Roche Diagnostics GmbH John Valliere-Douglass, Seattle Genetics, Inc. James Carroll, Pfizer, Inc. Christopher Yu, Genentech, a Member of the Steven Cohen, Northeastern University Roche Group (Co-chair) Eef Dirksen, Synthon Biopharmaceuticals B.V. (Co-chair) Vivian Lindo, MedImmune, A member of the AstraZeneca Group 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 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, 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 coming this summer. 4 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 Gold Program Partner Pfizer, Inc. Diamond Program Partner Agilent Technologies Platinum Program Partners Bruker Daltonics, Inc. Genedata AG Gold Program Partners Genentech, a Member of the Roche Group Roche Diagnostics GmbH SCIEX 5 Exhibitor Partners 908 Devices Agilent Technologies Bruker Daltonics, Inc. CMP Scientific Eurofins Lancaster Laboratories, Inc. Genedata AG Genovis AB Protein Metrics SCIEX 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 7 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 Facilitators: 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: TBD 08:45 – 09:45 New MS/MS Strategies for Analysis of Protein, Protein Complexes and Biotherapeutics: Ultraviolet Photodissociation 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: TBD 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 TBD 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: TBD 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