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Reference Standards for Therapeutic Proteins:
Their Relevance, Development, Qualification
and Replacement
Scientific / Organizing Committee
Tony Mire-Sluis, Amgen Inc.
Barry Cherney, FDA
Tony Lubiniecki, JNJ
Day 1 - Tuesday, September 20, 2011
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7:30am
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Registration
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8:00am
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Introduction to the meeting and IABS
Tony Mire-Sluis, Amgen Inc. IABS Introduction
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Session 1 - Understanding the attributes required for reference standards (primary, working etc.) and the purpose of their use.
Chairpersons: Tony Lubiniecki, JNJ; Ned Mozier, Pfizer
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8:15am
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The selection and utility of potency standards for biotechnology products.
Evangelos Bakopanos, Health Canada Slides
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8:45am
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The role of physicochemical standards in the control of biotechnology products.
(what to use for system suitability versus actual measurements, comparison standards
such as ID etc.)
Barry Cherney, FDA Slides
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9:15am
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The role of NIST standards and an update on the desirable properties and development
of protein particle standards.
Dean Ripple, NIST Slides
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9:45am
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Break
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10:15am
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Selection and use of standards for immunogenicity assays.
Gopi Shankar, Centocor Slides
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10:45am
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Roundtable discussion
Evangelos Bakopanos, Health Canada; Barry Cherney, FDA; Mike Tarlov, NIST;
Gopi Shankar, Centocor, Chana Fuchs, DMA, FDA
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12:00pm
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Lunch
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Session 2 - Selection, qualification and stability programs for reference standards.
Chairpersons: Joe Kutza, Medimmune; Bob Mattaliano, Genzyme
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1:00pm
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Qualifying potency standards and assurance of prevention of potency drift over time.
Helena Madden, Biogen Idec Slides
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1:30pm
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The qualification and control of reference standards for biochemical / biophysical assays.
David Lee, Abbott Slides
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2:00pm
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Developing a program to create, qualify and keep stable host cell protein assays.
Marty Vanderlaan, Genentech Slides
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2:30pm
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Break
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3:00pm
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Reference standards for vaccines
Rajesh Gupta, CBER, FDA Slides
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3:30pm
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Roundtable discussion
Helena Madden, Biogen Idec; David Lee, Abbott; Marty Vanderlaan, Genentech;
Rajesh Gupta, CBER/FDA; Bill Egan, Pharmanet
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Day 2 - Wednesday, September 21, 2011
Session 3 - Replacement of reference standards.
Chairpersons – Bill Egan, Pharmanet; Barbara Rellahan, DMA, FDA
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8:30am
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Challenges with the replacement of potency standards?
Noel Rieder, Amgen Slides
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9:00am
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When and how to replace physicochemical standards.
Carla Lankford, FDA Slides
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9:30am
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Role of the ISICR standards program in the control of biotechnology products
Michael Tovey, ISICR Slides
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10:00am
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Break
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10:30am
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Roundtable discussion
Noel Rieder, Amgen; Carla Lankford, FDA; Michael Tovey, ISICR; Ned Mozier, Pfizer
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12:00pm
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Lunch
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Session 4 - The role of public standards in the development and control of
biotechnology medicinal protein products.
Chairperson – Mike Tarlov, NIST
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1:00pm
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WHO International Standards.
Colin Longstaff, NIBSC Slides
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1:25pm
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The development and use of pharmacopoeia monographs and reference standards.
Guy Rautmann, EDQM Slides
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1:50pm
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Latest developments in pharmacopoeia monographs and harmonization.
Tina Morris, USP Slides
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2:15pm
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Roundtable discussion
Colin Longstaff, NIBSC; Guy Rautmann, EDQM; Tina Morris, USP; Kathy Zoon, NIAID
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3:00pm
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Summary of meeting
Tony Mire-Sluis, Amgen Inc. Slides
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4:00pm
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End of meeting
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To the members of IABS