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Archived Webinar Conducted Dec 10, 2009
Protein Aggregation and Immunogenicity
Harald Kropshofer, Ph.D., F. Hoffmann La Roche, Basel, Switzerland
Vision & Mission
The Protein Aggregation and Biological Consequences 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:
- establish a core group of interested investigators
- define the questions that need to be answered to understand protein aggregation (techniques, factors causing aggregation)
- define the questions that need to be answered to understand the potential impact of protein aggregation on immunogenicity and e.g. pharmacokinetics, activity, etc.
- promote research and cross-functional collaborations in this area
- promote discussions and education
The membership of this group will contain experts in formulation, analytics, regulatory and clinical and preclinical safety and immunology.
Newsletters
Literature Collection Portal
Welcome to our literature collection portal. Our goal is to provide you with a structured reference of published information to foster focused scientific discussions in the community around the topics of protein aggregation/particles and observations of unwanted reactions, especially immunogenicity. This is a strictly voluntary effort for which we kindly ask for your knowledgeable contributions.
How It Works
To give us your input, we kindly ask to follow these steps.
- Download the Excel spreadsheet template. Please note: the spreadsheet uses macros.
- Populate the template with citations of your choice and select classifications you feel are appropriate.
- Submit the filled-out template via email by clicking here.
What We Will Do
- Roll-up your contributed citations into an overall collection spreadsheet.
- Regularly publish the updated overall spreadsheet on the focus group webpage and make it available for download.
Workshop on Protein Aggregation Meeting Presentations
July 20-22, 2010, Breckenridge, Colorado
Presented by the University of Colorado Center for Pharmaceutical Biotechnology, the AAPS Focus Group on Protein Aggregation and Biological Consequences, and the U.S. Food and Drug Administration.
JOIN THE PROTEIN AGGREGATION AND BIOLOGICAL CONSEQUENCES FOCUS GROUP
To join the Protein Aggregation and Biological Consequences Focus Group, click here.
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