The Organizing Committee Gratefully Acknowledges the Symposium
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2nd Symposium on Higher Order Structure of Protein Therapeutics February 11 – 13, 2013 Hyatt Regency Baltimore on the Inner Harbor Baltimore, Maryland USA Organized by 1 Table of Contents Program Partners ..........................................................................................................3 Exhibitor and Media Partners.......................................................................................4 Acknowledgements ......................................................................................................5 Student Travel Grants ..................................................................................................6 Scientific Final Program Summary ..............................................................................7 Plenary and Session Abstracts .....................................................................................16 Technical Seminar I (Monday, February 11) Abstract ................................................55 Technical Seminar II (Tuesday, February 12) Abstract...............................................56 Technical Seminar III (Tuesday, February 12) Abstract .............................................57 Poster Abstracts ............................................................................................................58 2 The Organizing Committee gratefully acknowledges the Corporate Program Partners for their generous support of the 2nd Symposium on Higher Order Structure of Protein Therapeutics Sustaining Gold Program Partners AbbVie Inc. Agilent Technologies Sustaining Silver Program Partner Pfizer, Inc. Platinum Program Partners Biogen Idec Genentech, a Member of the Roche Group Gold Program Partner Amgen Inc. Silver Program Partners Bristol-Myers Squibb Company Eli Lilly and Company Bronze Program Partner Fujifilm Diosynth Biotechnologies 3 Exhibitor Partners Agilent Technologies Applied Photophysics Ltd. BioTools, Inc. ExSAR™ Corporation JASCO KBI Biopharma Malvern Instruments, Inc. NanoSight, LLC Pall Life Sciences TA Instruments Waters Corporation Wyatt Technology Corporation Leading Media Partner Technology Networks Limited 4 Acknowledgements Symposium Co-Chairs: Wasfi Al-Azzam, GlaxoSmithKline Pharmaceuticals Steven Cohen, Waters Corporation Scientific Program Committee: Steven Berkowitz, Biogen Idec Katherine Bowers, Fujifilm Diosynth Biotechnologies John Carpenter, School of Pharmacy, University of Colorado at Denver Guodong Chen, Bristol-Myers Squibb Company Otmar Hainzl, Sandoz Biopharmaceuticals Wim Jiskoot, LACDR, Leiden University Tom Laue, University of New Hampshire Aston Liu, GlaxoSmithKline Pharmaceuticals Jamie Moore, Genentech, a Member of the Roche Group Radhika Nagarkar, KBI Biopharma Inc. Linda Narhi, Amgen Inc. Jason Rouse, Pfizer, Inc. Satish Singh, Pfizer, Inc. William Weiss, Eli Lilly and Company Audio-Visual: Michael Johnstone, MJ Audio-Visual Productions CASSS Staff: Karen Bertani, Symposium Manager Stephanie Flores, Executive Director Linda Mansouria, Manager of Meetings and Events Renee Olson, Manager of Meetings and Events Mikaela Sanford, Project Coordinator Catherine Stewart, Finance Manager 5 CASSS Higher Order Structure 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 2nd International Symposium on Higher Order Structure of Protein Therapeutics (HOS 2013). PhD students or post-doctoral fellows conducting research at academia throughout the world are eligible. This year’s winner is: P-04 Hai Yue Washington University, St. Louis, University City, MO USA Development of Far-UV and Near-UV Circular Dichroism Method for the Characterization and Comarability of Protein Higher Order Structure 6 2nd International Symposium on Higher Order Structure of Protein Therapeutics Scientific Program Summary MONDAY, FEBRUARY 11, 2013 07:00 – 17:00 Registration in the Constellation Ballroom Foyer 07:00 – 08:30 Continental Breakfast in Constellation Ballroom A 08:00 – 08:15 CASSS Welcome and Introductory Comments in Constellation Ballroom B Steven Cohen, Waters Corporation Higher Order Structure Welcome and Introductory Comments in Constellation Ballroom B Wasfi Al-Azzam, GlaxoSmithKline Pharmaceuticals Keynote Session in Constellation Ballroom B Session Chairs: Wasfi Al-Azzam, GlaxoSmithKline Pharmaceuticals and Linda Narhi, Amgen Inc. 08:15 – 09:00 The Evolving Role of Analyzing Higher Order Structure for Biotechnology Products and its Scientific and Regulatory Implications Anthony Mire-Sluis, Amgen Inc., Thousand Oaks, CA USA Higher Order Structure Introduction and Fundamentals Plenary Session in Constellation Ballroom B Session Chairs: Norma Allewell, University of Maryland, College Park and Jason Rouse, Pfizer, Inc. 09:10 – 09:30 Effects of Silicone Oil and Silicone-coated Glass on Protein Aggregation John Carpenter, School of Pharmacy, University of Colorado, Denver, Aurora, CO USA 09:30 – 09:50 Structures of Amyloid Precursor Protein in a Membrane Environment David Thirumalai, University of Maryland, College Park, MD USA 09:50 – 10:10 Structural Principles of Insulin Analog Design Michael Weiss, Case Western University of Medicine, Cleveland, OH USA 10:10 – 10:30 Chaperoning Antibody Folding and Assembly Johannes Buchner, Technical University Munich, Munich, Germany 10:30 – 11:00 AM Break – Visit the Exhibits and Posters in Constellation Ballroom A 7 Monday, February 11 continued… 11:00 – 11:20 The Present State and Future Outlook for Characterizing the Higher Order Structure of Protein Drugs in the Biopharmaceuticals Industry Steven Berkowitz, Biogen Idec, Cambridge, MA USA 11:20 – 11:45 Discussion – Questions and Answers Hydrogen/Deuterium Exchange Mass Spectrometry in Higher Order Structures Plenary Session in Constellation Ballroom B Session Chairs: Guodong Chen, Bristol-Myers Squibb and Steven Cohen, Waters Corporation 11:45 – 12:05 Hydrogen/Deuterium Exchange Mass Spectrometry: A Valuable Tool for Protein Higher Order Structure Characterization Roxana Iacob, Northeastern University, Boston, MA USA 12:05 – 12:25 Applications of Hydrogen/Deuterium Exchange Mass Spectrometry in Comparability Studies and Epitope Mapping Jingjie Mo, Bristol-Myers Squibb Company, Princeton, NJ USA 12:25 – 12:45 Hydrogen/Deuterium Exchange with Mass Spectrometry Detection for Higher Order Structure Evaluation of Therapeutic Proteins Ingo Lindner, Roche Diagnostics GmbH, Penzberg, Germany 12:45 – 13:05 Impact of Chemical Degradation on the Conformational Dynamics of Monoclonal Antibody Ping Hu, GlaxoSmithKline, King of Prussia, PA USA 13:05 – 13:30 Discussion – Questions and Answers 13:30 – 15:00 Lunch Break – Participants on their own HOS in Protein Therapeutics Discovery and Early Candidate Selection Plenary Session in Constellation Ballroom B Session Chairs: Yijia Jiang, Amgen Inc. and Jamie Moore, Genentech, a Member of the Roche Group 15:00 – 15:20 Integrated Early Developability Assessment: Monitoring Higher Order Structure Attributes for Candidate Selection Alla Polozova, MedImmune, Gaithersburg, MD USA 15:20 – 15:40 Molecule Assessment and Early Development Cynthia Li, Amgen Inc., Thousand Oaks, CA USA 8 Monday, February 11 continued… 15:40 – 16:00 Understanding Sequence/Structure Impact on Pharmaceutical Development of a Monoclonal Antibody Vikas Sharma, Genentech, a Member of the Roche Group, South San Francisco, CA USA 16:00 – 16:30 Discussion – Questions and Answers 16:30 – 17:00 PM Break – Visit the Exhibits and Posters in Constellation Ballroom A 17:00 – 18:00 Technical Seminar Advances in the Integrated Measurements of Protein Size and High Order Structure Sponsored by Malvern Instruments, Inc. Constellation Ballroom B Young Scientists Plenary Session in Constellation Ballroom B Session Chairs: Wasfi Al-Azzam, GlaxoSmithKline and Steven Cohen, Waters Corporation 18:15 – 18:30 Development of Far-UV and Near-UV Circular Dichroism Method for the Characterization and Comparability of Protein Higher Order Structure Hai Yue, Washington University, St. Louis, University City, MO USA 18:30 – 20:00 Exhibitor and Poster Session One in Constellation Ballroom A 20:00 Adjourn Day One 9 TUESDAY, FEBRUARY 12, 2013 07:30 – 17:30 Registration in the Constellation Ballroom Foyer 07:30 – 08:45 Continental Breakfast in Constellation Ballroom A Process Development: HOS Studies for Formulations and Stability Plenary Session in Constellation Ballroom B Session Chairs: Katherine Bowers, Fujifilm Diosynth Biotechnologies and Anthony Cannon, Grifols, Inc. 08:30 – 08:50 Similarity of Higher Order Structure: Moving Towards Best Practices for Spectral Comparability Mark Manning, Legacy BioDesign, LLC, Johnstown, CO USA 08:50 – 09:10 High-throughput Biophysical Analysis of Protein Stability Applied to Both Formulation Development and Comparability Assessments David Volkin, University of Kansas, Lawrence, KS USA 09:10 – 09:30 Doing More with Less – High Throughput Development and its Applications in Protein Therapeutic Formulation Development Feng He, Amgen Inc., Seattle, WA USA 09:30 – 09:50 Assessment of Particles in Prefilled Syringes of Protein-based Products: Case Studies Jun Park, CDER, FDA, Bethesda, MD USA 09:50 – 10:20 Discussion – Questions and Answers 10:20 – 10:50 AM Break – Visit the Exhibits and Posters in Constellation Ballroom A HOS in Development: Characterization and Comparability Plenary Session in Constellation Ballroom B Session Chairs: Linda Narhi, Amgen Inc. and Leonard Olszewski, GlaxoSmithKline 10:50