Another conference.
BSP 99 - Biological Safety & Production
April 19-23, 1999 · The World Trade Center · Boston, MA
ibcusa.com
Day One - Viral Clearance
8:20 Chairperson's Opening Remarks
Barbara Potts, Ph.D., Director of Retrovirology, Tektagen, Inc.
Session I: Novel Methods
8:30 Iodine Sepharose Treatment of Immunoglobulins for Inactivation
of Virus
Shirley Miekka, Ph.D., Manager of Viral Inactivation Research, American Red Cross
9:05 Microwave Heat Inactivation of Virus: Experiences from GMP -
Manufacture of Biopharmaceutical Proteins at Large Technical
Scale
Joachim K. Walter, Ph.D., Boehringer Ingelheim, Germany
9:40 Inactivation of Non-Enveloped Viruses by UVC
Bernard Horowitz, Ph.D., Executive Vice President and Chief
Scientific Officer, V.I. Technologies, (VITEX)
10:15 Networking Refreshment Break
10:50 Update on Pentose's Viral Inactivation (Inactine) Method
Clark Edson, Ph.D., Head, Molecular Virology, Pentose
Pharmaceuticals, Inc.
11:25 Ethyleneimines, General Virus Inactivants
Fred Brown, Ph.D., F.R.S., Visiting Scientist, Plum Island Animal Disease Center, Agricultural Research Service, USDA
12:00 Networking Luncheon and Address
From Lab to Launch - The Advanced Technology Program and the
Biotechnology Industry
Rosemarie Hunziker, Ph.D., Program Manager, Advanced Technology Program, National Institutes of Standards & Technology
1:35 Enhancing Virological Safety in Biopharmaceutical Production
through Membrane Filtration
Hazel Aranha-Creado, Ph.D., Senior Staff Scientist, Pall
Corporation
2:10 Virus Removal Filtration Studies Using PLANOVA Filters
Hiroo Nakano, Ph.D., General Manager of Science & Technology, PLANOVA Division, Asahi Chemical Industry America, Inc.
2:45 Networking Refreshment Break
Session II: Virus Removal/Inactivation Validations
3:15 Adventitious Virus Assays
Judith Sernatinger, Viral Security Manager, Bioassay Development, Biogen
3:50 Validation of Virus Removal and Inactivation During Production of Hemoglobins
Timothy Estep, Ph.D., Vice President, Research & Development, Baxter Healthcare Corporation
4:25 Viral Issues Associated with Transgenic Production of
Biopharmaceuticals
Carol Ziomek, Ph.D., Vice President, Development, Genzyme
Transgenics Corporation
5:00 Open Floor Q&A
5:30 Close of Day One
Day Two
8:20 Chairperson's Opening Remarks
Carol Ziomek, Ph.D., Vice President, Development, Genzyme
Transgenics Corporation
8:30 Virus Inactivation in Serum for Use in Cell Culture
Greg Hanson, Ph.D., Regulatory Affairs Manager, Hyclone
Laboratories, Inc.
9:05 Molecular Detection Technology in Virus Clearance Validation for Biological License Application
Shengjiang Liu, Ph.D., Scientist, Virology R & D, Cell Culture Fermentation, Genentech, Inc.
9:40 PCR-Based Viral Screens for Plasma Pools
Lorraine Peddada, Ph.D., Senior Principal Scientist, Alpha
Therapeutics
10:15 Networking Refreshment Break and Exhibit Viewing
10:50 Detection and Removal of Retroviruses
Barbara Potts, Ph.D.
11:25 Free Time - Exhibit Hall Open
Session III: Regulatory Developments and Concerns
12:50 Virus Validation - Pointers for a Successful Virus Evaluation Study
Gail Sofer, Director, Regulatory Services, BioReliance
1:25 Validation of Biological Assays
David Lansky, Ph.D., Senior Statistician, G.D. Searle
2:00 FDA Regulatory Considerations
Carol Marcus-Sekura, Ph.D., Executive Vice President,
Biotechnology Assessment Services, Inc.
2:35 Networking Refreshment Break and Exhibit Viewing
3:05 Explanation of How this Regulatory Body Works and Interacts
with the FDA
Sally Seaver, Ph.D., UC Pharmacopia Standards and Monographs
in Cell & Gene Therapy Committee
3:40 Regulatory Perspective - Realistic Expectations for Virus
Removal or Inactivation
Hannelore Wilkommen, Ph.D., Head, Section of Viral Safety,
Paul-Ehrlich-Institut
4:30 Open Floor Q&A
5:00 Close of Day Two
5:00 Networking Cocktail Reception and Exhibit Viewing
Day Three - Prions
Keynote Address
8:30
Prions: Principle, Biology and New Assays
Jiri Safar, Ph.D., Prusiner's Laboratory, University of California, San Francisco
9:30 Evaluation of TSE Clearance and Correlation of Partitioning of PrPSC/RES and TSE Infectivity as a Result of Plasma and Biotechnology Manufacturing Processes
Steve R. Petteway, Jr., Ph.D., Research Director, Pathogen Safety, Bayer Corporation
10:10 Titer, Distribution, and Transfusability of Blood-Borne TSE
Infectivity in Animal Models
Robert Rohwer, Ph.D., Director, Molecular Neurovirology Unit, Veterans Affairs Medical Center
10:40 Networking Refreshment Break and Exhibit Viewing
11:10 Minimizing the Risk of Transmission of TSEs by Biologicals - A European Regulatory Perspective
Philip Minor, Ph.D., Head, Division of Virology, National Institute for Biological Standards and Control
11:50 Strategies for the Validation of Processes for the
Removal/Inactivation of TSEs
Andrew Bailey, Director, Process Validation, Q-One Biotech, Ltd., Glasgow
12:30 Networking Luncheon Buffet
2:00 U.S. Regulatory Perspective for Prion Issues
David Asher, Ph.D., Laboratory Chief, Center for Biological Evaluation & Research,Food and Drug Administration (Invited)
2:40 The Effectiveness of Prion Inactivation Methods
David M. Taylor, Ph.D., FIBMS, FIScT, Principal Research Scientist, Neuropathogenesis Unit, Institute for Animal Health
3:20 Networking Refreshment Break and Exhibit Viewing
3:50 Evaluation of the Risk of BSE in Pharmaceutical Products
Fredric G. Bader, Ph.D., Vice President, Worldwide Operations, Centecor, Inc.
4:30 Preclinical Detection of Sheep Infected with Scrapie by
Immunostaining of the Nictitating Membrane Associated
Lymphoid Tissue
Donald P. Knowles, Jr., Ph.D., Research Leader, Animal Disease Research Unit, Agricultural Research Service, U.S. Department of Agriculture
5:10 Chairperson's Closing Remarks
5:20 Close of Day Three
5:20 Networking Cocktail Reception
Sponsored by:
Day Four - Plasma Protein Production
8:30 Opening Remarks
John Curling, John Curling Consulting, AB, Sweden
Session I: Industry Overview
Session Chair: Bernard Horowitz, Ph.D., Executive Vice President & Chief Scientific Officer, V.I. Technologies, (VITEX)
8:45 Plasma Products: The Challenge to Change
Roman Drews, Ph.D., Scientist, Plasma Derivatives Department, Holland Laboratory,American Red Cross
9:15 The WorldWide Plasma Fractions Market: Analysis and Trends
Patrick Robert, President, Marketing Research Bureau, Inc.
9:45 U.S. Industry: Trends and New Products
Wayne G. Johnson, CEO, Canadian Plasma Products
10:15 Human Plasma as a Source Material
David Hammond, Ph.D., Director of Plasma Proteins, V.I.
Technologies, (VITEX)
10:45 Networking Refreshment Break and Exhibit Viewing
11:15 Recent Developments in Plasma Fractionation Separation
John Chickosky, Senior Vice President of Sales, Carr Separations, Inc.
Session II: Alternative Expression Systems for Plasma Proteins
Session Chair: William Velander, Pharmaceutical Engineering Institute, Department of Chemical Engineering, Virginia Tech
11:45 Alternative Recombinant Sources of Plasma Proteins
William Velander
12:15 Tissue Specific Gene Targeting
Lothar Hennighausen, Ph.D., Chief, Laboratory of Genetics and Physiology, National Institutes of Health
12:45 Networking Luncheon and Exhibit Viewing
2:00 Choices of Expression Systems for Plasma Proteins
Berthold Boedeker, Bayer Corporation, Germany
2:30 Progress in the Expression of Plasma Proteins in Plants
Carole L. Cramer, Ph.D., Chief Scientific Officer, Crop Tech
Development Corp.; Professor, Fralin Biotechnology Center, Virginia Tech
Session III: "Human Serum" Albumin
Session Chair: Prabir Bhattacharya, Ph.D., Alpha Therapeutic
Corporation
3:00 From Cohn to Chromatography: Developing Processes for HSA
Wayne Adcock, Ph.D., Albumin Production Manager, CSL Bioplasma, Ltd., Australia
3:30 Networking Refreshment Break and Exhibit Viewing
4:00 Characteristics of Albumin Expressed in Yeast (S. cerevisae)
James Ballance, Ph.D., Director of Research and Development, Delta Biotechnology, Ltd.
4:30 Recovery of Albumin Expressed in Yeast (P. pastoris)
L.A.M. van der Wielen, Professor, Kluyver Institute for
Biotechnology, The Netherlands
5:00 Progress Towards Expression of Albumin in Transgenic Cows
Scott P. Fulton, Director, Development, Genzyme Transgenics Corp.
5:30 Close of Day Four
Day Five
Session IV: Immunoglobulins
Session Chair: Fred Rothstein, Ph.D., President, BioSeparations Consultants
8:00 Enhancing the Safety of IVIG - The Impact of Process Change on the Safety Profile of IVIG
Don Baker, Ph.D., Vice President, Technology Assessment, Baxter Healthcare Corporation
8:30 The Safety of Processes for IVIG Manufacturing
Jean-Jacques Morgenthaler, Ph.D., Senior Vice-President, Red Cross Foundation Central Laboratory, Blood Transfusion Service, SRC,
Switzerland
Session V: Coagulation Factors
Session Chair: Michael H. Coan, Ph.D., Manager, Protein Chemistry and Virology, Bayer Corporation
9:00 The Future of Plasma-Derived, High Purity Factor VIII and IX
Fred Feldman, Ph.D., Vice President, Preclinical Research &
Development and Biotechnology Evaluation, Centeon, LLC
9:30 Production of Recombinant Coagulation Factors VIII and IX
Representative from Genetics Institute
10:00 Networking Refreshment Break
10:30 Recombinant Factor VII: Process Design and Product Purity
Inger Mollerup, M.S., Manager, Novo Nordisk A/S, Denmark
11:00 The Use of Monoclonal Antibodies in the Purification of
Coagulation Factors
Po Shing Wah, Ph.D., Director, Technical Services, Baxter
Healthcare Corporation
Session VI: No Longer "Trace Proteins of Plasma"
Session Chair: John Curling
11:30 Clinical Development of Sheep Transgenic alpha-1 anti-trypsin
Paul Rohricht, US Business Development, PPL Therapeutics
12:00 Development of Yeast, Recombinant alpha-1 anti-trypsin
Ian Bathurst, Ph.D., Vice President of Manufacturing and Process Development, AlphaOne Pharmaceuticals, Inc.
12:30 Free Time
2:00 Purification of Alpha-1 Proteinase Inhibitor from Plasma
James E. Wydick, III, Senior Project Manager, Biological Products, Bayer Corporation
2:30 Clinical Development of Recombinant Human Anti-thrombin III
Suzanne Groet, Vice President, Business Development, Genzyme
Transgenics
3:00 Networking Refreshment Break
Session VII: Production Challenges
Session Chair: Vipin Garg, Ph.D., Vice President, Operations, Apex
Bioscience, Inc.
3:15 Challenges in the Production of Haemoglobin
Todd Talarico, Ph.D., Manager of Product Development, Apex
Bioscience, Inc.
3:45 Removal of Blood-Borne Viruses from an Immunoglobulin
Production Process by Nanofiltration
Daniel Revie, Process Development Manager, Immunotherapy Division, NABI
4:15 Close of BSP 99
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