7 th International Symposium on Higher Order Structure of Protein Therapeutics (HOS 2018)

Transcription

1 7 th International Symposium on Higher Order Structure of Protein Therapeutics (HOS 2018) Symposium Co-Chairs: Guodong Chen, Bristol-Myers Squibb Company David Keire, CDER, FDA April 9-11, 2018 Omni Providence Hotel Providence, RI USA Organized by 1

2 Table of Contents Program Partners, Exhibitors, and Media Partners... Acknowledgements... Student Travel Grants... Scientific Final Program Summary... Plenary and Session Abstracts... Poster Abstracts... 2

3 The organizing committee gratefully acknowledges the program partners and exhibitors for their generous support of the 7 th International Symposium on Higher Order Structure of Protein Therapeutics Strategic Platinum Program Partner MedImmune, A member of the AstraZeneca Group Strategic Gold Program Partners Eli Lilly and Company Pfizer, Inc. Strategic Silver Program Partner Biogen Platinum Program Partner Amgen Inc. Silver Program Partner Genentech, a Member of the Roche Group Bronze Program Partner FUJI Film Diosynth Biotechnologies 3

4 Exhibitor Partners Beckman Coulter Life Sciences Bruker Daltonics, Inc. Charles River Laboratories NanoImaging Services, Inc. Postnova Analytics Inc. Protein Metrics Inc. Thermo Fisher Scientific Waters Corporation 4

5 The organizing committee gratefully acknowledges the following media partners for their promotional consideration of HOS 2018 Media Partners American Laboratory/labcompare American Pharmaceutical Review BioProcessing Journal Genetic Engineering & Biotechnology News LCGC North America Pharmaceutical Outsourcing Technology Networks 5

6 Symposium Co-Chairs: Guodong Chen, Bristol-Myers Squibb Company David Keire, CDER, FDA Acknowledgements Scientific Program Committee: Wasfi Al-Azzam, GlaxoSmithKline Yves Aubin, Health Canada Alexander Bepperling, Novartis Katherine Bowers, FUJIFILM Diosynth Biotechnologies Shawn Cao, Amgen Inc. Natalie Ciaccio, BioMarin Pharmaceuticals Inc. Galahad Deperalta, Genentech, a Member of the Roche Group Tom Lerch, Pfizer, Inc. Krishna Mallela, University of Colorado Anschutz Medical Campus Anders Nielsen, Novo Nordisk A/S Gang (Gary) Ren, Lawrence Berkeley National Laboratory John Schiel, National Institute of Standards and Technology (NIST) William Weiss, Eli Lilly and Company Audio-Visual: Michael Johnstone, MJ Audio-Visual Productions CASSS Staff: Karen Bertani, Director of Meetings Amy Cano, Administrative Assistant Stephanie Flores, Executive Director Julie Fowle, Meeting Coordinator Anna Lingel, Meeting Coordinator Carisa Lubeck, Business Information Analyst Renee Olson, Senior Program Manager Catherine Stewart, Finance Manager 6

7 Student Travel Grants CASSS is pleased to provide a limited number of student travel grants for Ph.D. students and post-docs who present applicable posters at the 7th International Symposium on Higher Order Structure of Protein Therapeutics (HOS 2018)). Ph.D. students or post-doctoral fellows conducting research at academia throughout the world are eligible. This year s grant winners include: Effect of Deamidation on the Structure and Function of a Therapeutic Protein Interferon alpha-2a Swati Bandi, University of Colorado Anschutz Medical Campus, Aurora, CO USA Physiologically-relevant Crowding Effects on a Protein-peptide Interaction Samantha Stadmiller, University of North Carolina at Chapel Hill, Chapel Hill, NC USA Biophysical Analysis of Zinc-induced Amyloidogenesis of a Biofilm Adhesion Protein Alexander Yarawsky, University of Cincinnati College of Medicine, Cincinnati, OH USA Characterization of IL-7/ IL-7Rα Binding Interface and Structural Dynamics through Chemical Cross-linking Mengru Zhang, Washington University in St. Louis, St. Louis, MO USA 7

8 7th International Symposium on Higher Order Structure of Protein Therapeutics Scientific Program Summary Monday, April 9, :30 18:00 Registration in the Narragansett Ballroom Foyer 07:30 08:30 Continental Breakfast in Narragansett B&C Ballroom 08:30 08:45 Welcome and Introductory Comments in Narragansett A Ballroom David Keire, CDER, FDA, St. Louis, MO USA Keynote I Session in Narragansett A Ballroom Session Chair: William Weiss, Eli Lilly and Company, Indianapolis, IN USA 08:45 09:45 Manipulating Protein Structure for Therapeutic Utility (Engineering for Properties That Mother Nature Never Had to Consider) John Beals, Eli Lilly and Company, Indianapolis, IN USA 09:45 10:15 Networking Break Visit the Exhibits and Posters in Narragansett B&C Ballroom Discovery and Candidate Selection Session in Narragansett A Ballroom Session Chair: Wasfi Al-Azzam, GlaxoSmithKline, King of Prussia, PA USA 10:15 10:35 Determination of Interaction Parameters for Reversibly Self-Associating Antibodies: A Comparative Analysis David Bain, University of Colorado Anschutz Medical Campus, Aurora, CO USA 10:35 10:55 Sequence and Structure Inspire Predictive Tools for Developability Assessment of Antibody Molecules Stanley Krystek, Bristol-Myers Squibb Company, Princeton, NJ USA 10:55 11:15 Early Analytical Characterization and Selection of Novel Biotherapeutics Dana Filoti, AbbVie, Inc, Boston, MA USA 11:15 11:40 Discussion Questions and Answers 11:40 13:10 Hosted Lunch in Narragansett B&C Ballroom 8

9 Monday, April 9, 2018, continued 13:10 14:10 Technical Seminar Sponsored by Waters Corporation Narragansett A Ballroom HOS in Development Session in Narragansett A Session Chairs: Natalie Ciaccio, BioMarin Pharmaceuticals Inc., Novato, CA USA and Anders Nielsen, Novo Nordisk A/S, Måløv, Denmark 14:10 14:30 Application of HDX-MS to Biopharmaceutical Development Requirements: Improved Sensitivity to Detection of Conformational Changes Lea Bonnington, F. Hoffmann - La Roche Ltd., Penzberg, Germany 14:30 14:50 What X-Ray Footprinting Can Tell You About Protein Interactions and Conformation Corie Ralston, Lawrence Berkeley National Laboratory, Berkeley, CA USA 14:50 15:10 Effects of Excipients of Filgrastim Products on the Structure and Dynamics of the Drug Substance Yves Aubin, Health Canada, Ottawa, ON Canada 15:10 15:35 Discussion Questions and Answers 15:35 16:35 Poster Session in Narragansett B&C Ballroom Biological Consequences of HOS Session in Narragansett A Ballroom Session Chairs: Galahad Deperalta, Genentech, a Member of the Roche Group, South San Francisco, CA USA and Krishna Mallela, University of Colorado Anschutz Medical Campus, Aurora, CO USA 16:35 16:55 Linking Structure to Function, Criticality Assessment of Thiol-Related Variants in Therapeutic mabs Yan Chen, Genentech, a Member of the Roche Group, South San Francisco, CA USA 16:55 17:15 Immunogenicity of Protein Aggregates: What s New? Wim Jiskoot, Leiden University, Leiden, Netherlands 17:15 17:35 TBD Haripada Maity, Eli Lilly and Company, Indianapolis, IL USA 17:35 18:00 Discussion Questions and Answers 9

10 Monday, April 9, 2018, continued 18:00 19:30 Exhibitor Reception in Narragansett B&C Ballroom 10

11 Tuesday, April 10, :30 08:30 Continental Breakfast in Narragansett B&C Ballroom 08:00 18:00 Registration in the Narragansett Ballroom Foyer Keynote II Session in Narragansett A Ballroom Session Chair: Krishna Mallela, University of Colorado Anschutz Medical Campus, Aurora, CO USA 08:30 09:30 Approaches and Challenges for Quantifying Multi-body Interactions as Higher-order Structure for Key Product Attributes Christopher J. Roberts, University of Delaware, Newark, DE USA 09:30 10:00 Networking Break Visit the Exhibits and Posters in Narragansett B&C Ballroom Established Methods and Fundamentals for HOS Session in Narragansett A Ballroom Session Chair: Yves Aubin, Health Canada, Ottawa, ON Canada and William Weiss, Eli Lilly and Company, Indianapolis, IN USA 10:00 10:20 IgG Cooperativity Tom Laue, University of New Hampshire, Durham, NH USA 10:20 10:40 Quantitative Characterization of the Effect of Small Molecules on Reversible Protein Associations via Dynamic Light Scattering Allen Minton, National Institute of Health (NIH), Bethesda, MD USA 10:40 11:00 Time-resolved Fluorescence Spectroscopy: An Old Technique to Monitor Protein Higher Order Structure Changes Sergey Arzhantsev, CDER, FDA, St. Louis, MO USA 11:00 11:25 Discussion Questions and Answers 11:25 12:25 Technical Seminar Sponsored by Thermo Fisher Scientific Narragansett A Ballroom 12:25 13:25 Hosted Lunch in Narragansett B&C Ballroom 11

12 Tuesday, April 10, 2018, continued Emerging Technology for HOS Evaluation Session in Narragansett A Ballroom Session Chairs: Tom Lerch, Pfizer, Inc., Chesterfield, MO USA and Gang (Gary) Ren, Lawrence Berkeley National Laboratory, Berkeley, CA USA 13:25 13:45 Seeing Is Believing: How We Use Single-molecule 3D Image to Understand ph-dependent HOS Change in a IgG1 Homodimer Ming Lei, Genentech, a Member of the Roche Group, South San Francisco, CA USA 13:45 14:05 Identifying HOS Variation with Multivariate Analysis of 2D NMR John Marino, National Institute of Standards and Technology (NIST), Rockville, MD USA 14:05 14:25 Coherent 2D IR: Introduction to a Powerful New Structural Spectroscopy and Application to Difficult Protein Systems Chris Middleton, PhaseTech Spectroscopy, Inc., Madison, WI USA 14:25 14:50 Discussion Questions and Answers 14:50 15:20 Networking Break Visit the Exhibits and Posters in Narragansett B&C Ballroom Young Scientist Session in Narragansett A Ballroom Session Chairs: Alexander Bepperling, Sandoz GmbH, Oberhaching, Germany 15:20 15:35 Characterization of IL-7/ IL-7Rα Binding Interface and Structural Dynamics through Chemical Cross-linking Mengru Zhang, Washington University in St. Louis, St. Louis, MO USA 15:35 15:50 Biophysical Analysis of Zinc-induced Amyloidogenesis of a Biofilm Adhesion Protein Alexander Yarawsky, University of Cincinnati College of Medicine, Cincinnati, OH USA 15:50 16:05 Effect of Deamidation on the Structure and Function of a Therapeutic Protein Interferon alpha-2a Swati Bandi, University of Colorado Anschutz Medical Campus, Aurora, CO USA 16:05 16:20 Physiologically-relevant Crowding Effects on a Protein-peptide Interaction Samantha Stadmiller, University of North Carolina at Chapel Hill, Chapel Hill, NC USA 12

13 Tuesday, April 10, 2018, continued HOS Biosimilarity and Comparability in Narragansett A Ballroom Session Chairs: Shawn Cao, Amgen Inc., Thousand Oaks, CA USA and John Schiel, National Institute of Standards and Technology (NIST), Rockville, MD USA 16:20 16:40 The Role of Higher Order Structure in the Assessment of Comparability and Biosimilarity Brad Jordan, Amgen Inc., Thousand Oaks, CA USA 16:40 17:00 Leveraging X-ray Crystallography for Biosimilarity Assessment Tom Lerch, Pfizer, Inc., Chesterfield, MO USA 17:00 17:20 TBD George Bou-Assaf, Biogen, Cambridge, MA USA 17:20 17:45 Discussion Questions and Answers 17:45 18:30 Networking Break 18:30 19:30 Roundtable Discussion Session in the Narragansett B&C Ballroom 13

14 Wednesday, April 11, :30 08:30 Continental Breakfast in Narragansett B&C Ballroom 08:00 12:00 Registration in the Narragansett Ballroom Foyer Computational Methods for HOS Session in Narragansett A Ballroom Session Chair: Katherine Bowers, FUJIFILM Diosynth Biotechnologies, Cary, NC USA 08:30 08:50 Computational Approaches for Assessing Developability and Optimization of Biotherapeutics Alain Ajamian, Chemical Computing Group (CCG), Montreal, QC Canada 08:50 09:10 TBD 09:10 09:30 Structure-Based Engineering to Improve Homogeneity of Bi-specifics and ADCs Eric Bennett, Pfizer, Inc., Cambridge, MA USA 09:30 09:55 Discussion Questions and Answers 09:55 10:25 Networking Break Visit the Exhibits and Posters in Narragansett B&C Ballroom Late Breaking Session in Narragansett A Ballroom Session Chairs: Guodong Chen, Bristol-Myers Squibb Company, Princeton, NJ USA and David Keire, CDER, FDA, St. Louis, MO USA 10:25 10:45 Native Peptide Mapping New Method to Monitor HOS Changes in a QC Laboratory Michel Degueldre, UCB Pharma SA, Braine-L alleud, Belgium 10:45 11:05 Consequences of Sample Age on Biotherapeutic Higher Order Structure: Insights from Native Ion Mobility-Mass Spectrometry Methods Richard Kerr, CDER, FDA, St. Louis, MO USA 11:05 11:25 TBD 11:25 11:50 Discussion - Questions and Answers 11:50 12:00 Closing Remarks Guodong Chen, Bristol-Myers Squibb Company, Princeton, NJ USA 14