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  Protein Aggregation and Immunogenicity Focus Group

Vision & Mission
The Protein Aggregation and Immunogenicity Focus Group was formed to study protein aggregation and immunogenicity. Ideally and very globally, we are striving for an understanding of the qualitative and quantitative aspects of aggregation of therapeutic protein products, to discuss and develop techniques to study aggregation and factors that cause aggregation and to discuss potential impact of aggregation including immunogenicity and for example kinetics, (bio) activity.

The goals are to:

  1. establish a core group of interested investigators
  2. define the questions that need to be answered to understand protein aggregation (techniques, factors causing aggregation)
  3. define the questions that need to be answered to understand the potential impact of protein aggregation on immunogenicity and e.g. pharmacokinetics, activity, etc.
  4. promote research and cross-functional collaborations in this area
  5. promote discussions and education

The membership of this group will contain experts in formulation, analytics, regulatory and clinical and preclinical safety and immunology.


Workshop on Protein Aggregation Meeting Presentations
September 26-27, 2006, Breckenridge, Colorado
Presented by the University of Colorado Center for Pharmaceutical Biotechnology, the AAPS Protein Aggregation and Immunogenicity Focus Group, and the U.S. Food and Drug Administration

JOIN THE PROTEIN AGGREGATION AND IMMUNOGENICITY FOCUS GROUP

To join the Protein Aggregation and Immunogenicity Focus Group, click here.

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  Leadership

Chair
Satish K. Singh, Ph.D.
Pfizer, Inc.
Chesterfield, MO United States



Chair-Elect
Hanns-Christian Mahler, Ph.D.
F.Hoffmann-La Roche Ltd.
Basel, Switzerland



Past Chair
Mary Cromwell
Genentech, Inc.
South San Francisco, CA




Click here to fill out a focus group membership form.

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2009 World Stem Cell Summit
9/21/2009

Current Trends in Stability—Challenges with Today's New Products
9/24/2009

AAPS Workshop on Challenges and Opportunities in Establishing Scientific and Regulatory Standards for Assuring Therapeutic Equivalence of Modified Release Products
10/1/2009

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