Symposium Co-Chairs: Steffen Kiessig, F. Hoffmann La Roche Ltd. Henry Luo, Regeneron Pharmaceuticals, Inc.

Transcription

1 CE in the Biotechnology & Pharmaceutical Industries: 18 th Symposium on the Practical Applications for the Analysis of Proteins, Nucleotides and Small Molecules (CE Pharm 2016) Symposium Co-Chairs: Steffen Kiessig, F. Hoffmann La Roche Ltd. Henry Luo, Regeneron Pharmaceuticals, Inc. September 25-28, 2016 The Westin San Diego San Diego, CA Organized by 1

2 Table of Contents Welcome Letter... CE Pharm Award... Student Travel Grants... Program Partners, Exhibitors and Media Partners... Scientific Final Program Summary... Session Abstracts... Workshop I Description... Workshop II Description... Technical Seminar Abstract... Poster Abstracts... 2

3 Welcome to CE Pharm 2016: CE in the Biotechnology and Pharmaceutical Industries: 18 th Symposium on the Practical Applications for the Analysis of Proteins, Nucleotides and Small Molecules We are pleased to welcome you to CE Pharm 2016, a symposium devoted to the practical concerns that will strengthen the use of CE within the biotechnology and pharmaceutical industries. The goal of this symposium is to provide a forum for the discussion of recent developments in the analysis and characterization of protein therapeutics, nucleotides and small molecules by CE and related techniques. The symposium will feature presentations from leading experts within industry and regulatory agencies from around the world. Applications will highlight the use of CE in various areas of product development including high-throughput screening, process development, product characterization, formulation studies, validated lot release and stability testing. Attendees will have the opportunity to discuss the use of CE with regulatory agencies. In addition, CE troubleshooting approaches will be presented and instrumentation companies will show advances in CE instruments, sensitivity and reagents. The symposium will allow for open discussions aimed at improving and increasing the use of CE for analysis of proteins, small molecules, carbohydrates, metabolites, and other molecules, with a focus on validation and qualification, new technology and QbD. Workshops will focus on troubleshooting techniques and other topics. The success of this symposium will depend not only on the outstanding cast of experienced and knowledgeable speakers and workshop leaders, but also on the interactions and open discussions that take place among the attendees. We encourage you to participate whole-heartedly 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 generously giving their time and resources and also you for your attendance, which will make this endeavor a success. We gratefully acknowledge the generosity of our exhibitors and program partners: 908 Devices, Agilent Technologies, American Laboratory/Labcompare, American Pharmaceutical Review, Analyst, Analytical Methods, The Analytical Scientist, Biogen, BiOptic Inc., BioProcess International, ChemComm, Chemical Science, ChemSocRev, CMP Scientific, Eli Lilly and Company, Genentech, a Member of the Roche Group, Genetic Engineering & Biotechnology News, Green Chemistry, Integrative Biology, International Pharmaceutical Quality, LCGC, MedChemComm, The Medicine Maker, Molecular BioSystems, The Pathologist, PerkinElmer, Pfizer, Inc., ProteinSimple, Royal Society of Chemistry, seperationsnow.com, SCIEX and Technology Networks. We are thankful for the expert assistance of CASSS and the audiovisual expertise of Michael Johnstone from MJ Audio-Visual Productions. Their experience and guidance in the preparation of this symposium have been invaluable. THE SCIENTIFIC ORGANIZING COMMITTEE Tim Blanc, Eli Lilly and Company François de l'escaille, ANALIS s.a./n.v. Mei Han, Amgen Inc. Göran Hübner, Boehringer Ingelheim Pharma GmbH & Co. KG Steffen Kiessig, F. Hoffmann-La Roche Ltd. (Cochair) Nathan Lacher, Pfizer, Inc. C. Mark Lies, SCIEX Henry Luo, Regeneron Pharmaceuticals (Co-chair) David A. Michels, Genentech, a Member of the Roche Group SungAe Suhr Park, Amgen Inc. Richard Rustandi, Merck & Co., Inc. Oscar Salas-Solano, Seattle Genetics, Inc. Cari Sänger - van de Griend, Kantisto BV Zoran Sosic, Biogen Hermann Wätzig, Technical University Braunschweig Joel Welch, CDER, FDA 3

4 CE Pharm Award History and Qualifications Objective: Recognize and award an individual for sustained and significant contribution to the practical application of CE to the analysis of biotechnology and pharmaceutical products. Qualification for Award: a. Advocate for CE from biotechnology and pharmaceutical industry b. Technical advancement or considered as a leader in developing or implementing various CE applications, such as: New CE Application for R&D CE Method Qualification CE Method Validation CE Method Transfer c. Technical reputation, in terms of number of presentations, publications, and patents d. Dedication to CE Pharm meeting as speaker, tutor, poster presenter or committee member e. Mentor, advisor and advocate of industrial-based CE practitioners in other industrial applications such as food chemistry, forensics and clinical. Past Recipients of the "CE Pharm Award" include: Norberto Guzman Johnson & Johnson Kevin Altria GlaxoSmithKline Anthony Chen and Wassim Nashabeh Genentech, Inc Stacey Ma Genentech, Inc SungAe Suhr Park Amgen Inc Oscar Salas-Solano Seattle Genetics, Inc Franka Kálmán University of Applied Sciences Western Switzerland András Guttman Northeastern University Michel Girard Health Canada Cari Sänger - van de Griend Kantisto BV Winner will be announced Wednesday at 8:30 AM. Do you think we are missing someone influential? Add your suggestion to the list. Suggestions for next year s award can be submitted with your post-meeting evaluation. 4

5 CASSS CE Pharm Student Travel Grants CASSS is pleased to provide a limited number of student travel grants for students who present applicable posters at CE Pharm PhD students or post-doctoral fellows conducting research in academia or industry throughout the world are eligible. Why you should apply: This symposium gives insight into the current topics and issues under discussion within the pharmaceutical and biotech industry and, as such, gives attendees the opportunity to bridge between industry, academia and regulatory agencies. The presentations and workshops will be devoted to practical concerns that strengthen the use of CE within the biotechnology and pharmaceutical industries. Applications will highlight uses of CE in various areas of product development, including high-throughput screening, formulation studies, process development, product characterization and validated lot release and stability testing. As a participant, you will have an excellent opportunity to meet, network and participate in exchanging knowledge for mutual education with other CE practitioners. Requirements are: - Present a poster on a CE topic - Proof of studentship/post-doc status - Recommendation from the supervisor/advisor CASSS has awarded student travel grants to the following individuals: Simultaneous Determination of Protein Affinity and Heterogeneity by Capillary Electrophoresis Mass Spectrometry Rob Haselberg, Vrije Universiteit Amsterdam, The Netherlands Affinity Capillary Electrophoretic and Computational Methods for Binding Studies of P- selectin with Heparinoids Mona Mozafari, TU Braunschweig, Germany Capillary Zone Electrophoresis-electrospray Ionization-mass spectrometry for Xenopus Laevis Metabolomic Analysis Nicole Schiavone, University of Notre Dame, USA Coupling Capillary Zone Electrophoresis to a Q Exactive HF Mass Spectrometer for Topdown Proteomics: 580 Proteoform Identifications from Yeast Yimeng Zhao, University of Notre Dame, USA 5

6 The Organizing Committee gratefully acknowledges the following strategic partners for their generous support of this Symposium: Strategic Program Partners Diamond Genentech, a Member of the Roche Group Platinum Biogen Gold Pfizer, Inc. Diamond Program Partner ProteinSimple Platinum Program Partner SCIEX Gold Program Partners Agilent Technologies PerkinElmer Silver Program Partners Eli Lilly and Company Amgen Inc. 6

7 Welcome Reception Regeneron Pharmaceuticals Exhibitors 908 Devices Agilent Technologies BiOptic Inc. CMP Scientific PerkinElmer ProteinSimple Prince Technologies B.V. ProZyme SCIEX Thermo Fisher Scientific 7

8 The Scientific Organizing Committee gratefully acknowledges the following media for their promotional consideration of CE Pharm 2016: Media Program Partners American Laboratory/labcompare American Pharmaceutical Review Analyst Analytical Methods The Analytical Scientist BioProcess International ChemComm Chemical Science Chem Soc Rev Genetic Engineering & Biotechnology News Green Chemistry Integrative Biology International Pharmaceutical Quality LCGC MedChemComm The Medicine Maker Molecular BioSystems The Pathologist Royal Society of Chemistry separationsnow.com Technology Networks 8

9 CE Pharm 2016 Scientific Final Program Summary Sunday, September 25, :30 09:00 Breakfast (for course attendees ONLY) in the Pearl Room 08:30 13:00 Registration (for course attendees ONLY) in the 3 rd Floor Foyer 09:00 17:00 Short Course in Pearl Room Applications of Capillary Electrophoresis to the Analysis of Protein Therapeutics Short Course Facilitators: David A. Michels, Genentech, a Member of the Roche Group, South San Francisco, CA USA and Cari Sänger - van de Griend, Kantisto BV, Baarn, The Netherlands 10:30 11:00 Break in the Pearl Room 12:30 13:30 Hosted Lunch (for course attendees ONLY) in the Pearl Room 15:00 15:30 Break in the Pearl Room 16:30 17:30 Registration CE Pharm 2016 in the 3 rd Floor Foyer 17:00 19:00 Welcome Reception at the Pool Deck 9

10 Monday, September 26, :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 Crystal Ballroom Henry Luo, Regeneron Pharmaceuticals, Inc., Tarrytown, NY USA Keynote I Session in Crystal Ballroom Session Chair: Henry Luo, Regeneron Pharmaceuticals, Inc., Tarrytown, NY USA 08:45 09:30 Control Strategy as a Framework for Integrated Analytical and Process Development of Biotherapeutics and Vaccines Meg Ruesch, Pfizer, Inc., Chesterfield, MO USA 09:30 09:45 Discussion 09:45 10:15 Break Visit the Exhibits and Posters in Emerald Ballroom Protein Analysis and Emerging Therapeutics in Crystal Ballroom Session Chairs: Richard Rustandi, Merck & Co., Inc., West Point, PA USA and Hermann Wätzig, Technical University Braunschweig, Braunschweig, Germany 10:15 10:40 Purity Analysis of Bispecific Antibody by Affinity Capillary Electrophoresis Kathir Muthusamy, Regeneron Pharmaceuticals, Inc., Tarrytown, NY USA 10:40 11:05 TBD Todd Suscovich, Harvard University, Cambridge, MA USA 11:05 11:30 Novel CZE Method for the Quantification of Intact Virus Particles in Complex Matrices Quality by Design Method Development and Implementation in a GMP Environment Ewoud van Tricht, Janssen Infectious Diseases and Vaccines, Leiden, Netherlands 11:30 11:55 Evaluation of Capillary Electrophoresis as a Potential Alternative Method to Monitoring Fragment Levels in Antibody-drug Conjugates Nomalie Jaya, Seattle Genetics, Inc., Bothell, WA USA 11:55 12:10 Discussion 12:10 12:25 Lunch for Technical Seminar Attendees Please take lunch and return to Crystal Ballroom for the Lunch and Learn 10

11 Monday, September 26, 2016 continued 12:25 13:25 Technical Seminar/Lunch and Learn TBD Sponsored by SCIEX Crystal Ballroom 13:25 13:40 Mini Break Visit the Exhibits and Posters in Emerald Ballroom QbD and DoE for CE Session in Crystal Ballroom Session Chairs: Tim Blanc, Eli Lilly and Company, Branchburg, NJ USA and Göran Hübner, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany 13:40 14:05 Development and Validation of a Capillary Gel Electrophoresis Purity Assay for a Therapeutic Protein using the Quality by Design Approach: A Step Further in Analytical Lifecycle Management Jérémie Cuisenaire, UCB SA, Braine-l'Alleud, Belgium 14:05 14:30 Optimization of Capillary Zone Electrophoresis for Charge Heterogeneity Testing of Biopharmaceuticals using Enhanced Method Development Principles Bernd Moritz, F. Hoffmann - La Roche Ltd., Basel, Switzerland 14:30 14:55 Automated DOE for icief Peter Bryngelson, Biogen, Cambridge, MA USA 14:55 15:20 Quality by Design in the Development of Capillary Electrophoresis Methods for Recombinant Proteins Agatha Feltus, Elanco Animal Health, Greenfield, IN USA 15:20 15:35 Discussion 15:35 16:05 Break Visit the Exhibits and Posters in Emerald Ballroom 16:05 16:55 CE Pharm Partner Showcase 16:55 18:00 Workshop I: Troubleshooting in Crystal Ballroom Workshop Facilitators: Tim Blanc, Eli Lilly and Company, Branchburg, NJ USA and Cari Sänger - van de Griend, Kantisto BV, Baarn, The Netherlands 18:00 19:00 Exhibition Reception Visit the Exhibitors in Emerald Ballroom 11

12 Tuesday, September 27, :00 18:00 Registration in the Ballroom Foyer 07:30 08:30 Breakfast in Emerald Ballroom 07:30 08:30 1 st Time Attendee Breakfast in TBD Keynote II Session in Crystal Ballroom Session Chair: SungAe Suhr Park, Amgen Inc., Thousand Oaks, CA USA 08:30 09:15 High-Throughput Protein, Protein-Protein Interaction, and Metabolite Assays using CE Robert Kennedy, University of Michigan, Ann Arbor, MI USA 09:15 09:30 Discussion 09:30 10:00 Break Visit the Exhibits and Posters in Emerald Ballroom Deep Dive into CE Session in Crystal Ballroom Session Chairs : David Michels, Genentech, a Member of the Roche Group, South San Francisco, CA USA and Cari Sänger - van de Griend, Kantisto B.V., Baarn, Netherlands 10:00 10:25 cief Resolution versus pi Accuracy Gordon Freckleton, Eli Lilly and Company, Branchburg, NJ USA 10:25 10:50 Studying Aggregation of Proteins Using Capillary Electrophoresis Akram Khodabandehloo, UBC, Vancouver, BC Canada 10:50 11:15 TBD Thomas Niedringhaus, Genentech, a Member of the Roche Group, South San Francisco, CA USA 11:15 11:30 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 12:45 Technical Seminar/Lunch and Learn TBD Sponsored by ProteinSimple Crystal Ballroom 12:45 13:00 Mini Break Visit the Exhibits and Posters in Emerald Ballroom 12

13 Tuesday, September 27, 2016 continued Novel Technologies Session in Crystal Ballroom Session Chairs: Mei Han, Amgen Inc., South San Francisco, CA USA and Nathan Lacher, Pfizer, Inc., Chesterfield, MO USA 13:00 13:25 Knock! Knock! Who s there? Maurice Who? SungAe Suhr Park, Amgen Inc., Thousand Oaks, CA USA 13:25 13:50 Current Developments in CE/MS Analysis of Proteins Michael D. Knierman, Eli Lilly and Company, Indianapolis, IN USA 13:50 14:15 Mass Spectrometric Characterization of Impurities of an Antibody Separated by SDS-capillary Sieving Electrophoresis using CSE-CZE- MS Christian Neusüss, Aalen University, Aalen, Germany 14:15 14:40 cief Cross Platform Comparability Study of a Monoclonal Antibody John Barr, Amgen Inc., South San Francisco, CA USA 14:40 14:55 Discussion 14:55 16:50 Poster Session - Visit the Exhibits and Posters in Emerald Ballroom 16:50 17:50 Roundtable Discussion in Crystal Ballroom Roundtable Facilitator: François de l Escaille, ANALIS s.a./n.v., Suralee, Belgium 13

14 Wednesday, September 28, :00 15:00 Registration in the Ballroom Foyer 07:30 08:30 Breakfast in the Diamond Room Foyer 08:30 08:45 CE Pharm Award Presentation Regulatory Session in Diamond Room Session Chairs: Oscar Salas-Solano, Seattle Genetics, Inc., Bothell, WA USA and Joel Welch, CDER, FDA, Silver Spring, MD USA 08:45 09:20 Now You CE Me, Now You Don t: The Evolving Role of CE in the Control Strategy Sarah Kennett, CDER, FDA, Silver Spring, MD USA 09:20 09:45 Application of Microchip Capillary Electrophoresis in the Quality Control Laboratory Jeffery Schneiderheinze, Regeneron Pharmaceuticals, Inc., Tarrytown, NY USA 09:45 10:10 CE Applications in a QC Environment Jian Zhang, Genentech, a Member of the Roche Group, South San Francisco, CA USA 10:10 10:25 Discussion 10:25 10:45 Break in the Diamond Room Foyer Method Lifecycle Management Session in the Diamond Room Session Chairs: Mark Lies, SCIEX, Brea, CA USA and Zoran Sosic, Biogen, Cambridge, MA USA 10:45 11:10 The NISTmAb: A Comprehensively Characterized Reference Material to Support Biopharmaceutical Analytical Technology Development Abigail Turner, Institute for Bioscience and Biotechnology Research (IBBR), Rockville, MD USA 11:10 11:35 CE Analysis in GMP Environment What is that Noise? Jiu-Li Song, Amgen, Thousand Oaks, CA USA 11:35 11:55 Development on an icief Method for a Poorly Soluble ADC Derived from an IgG2 mab Conjugated with a Charged Drug-linker Adam Fung, Agensys, Inc., Santa Monica, CA USA 14

15 11:55 12:10 Discussion Wednesday, September 28, :10 12:25 Lunch for Technical Seminar Attendees Please take lunch and return to Diamond Room for the Lunch and Learn 12:25 13:05 Technical Seminar/Lunch and Learn TBD Sponsored by Thermo Fisher Scientific Diamond Room 13:05 13:20 Mini Break Please proceed to the Crystal Ballroom CE-MS Session in the Crystal Ballroom Session Chairs: Steven Cohen, Northwestern University, Boston, MA USA and Steffen Kiessig, F. Hoffmann - La Roche Ltd., Basel, Switzeraland 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. South San Francisco, CA USA 15:00 15:15 Closing Comments in Emerald Ballroom Steffen Kiessig, F. Hoffmann - La Roche Ltd., Basel, Switzerland 15