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Technology Challenges and Risk Analysis of Immunogenicity Assessment on Biologics*
Monday, November 12
2:00 pm – 4:30 pm
Symposium
ACPE #073-999-07-531-L04
All protein therapeutics (or biotherapeutics) are potentially immunogenic. Immunogenicity assessment of biotherapeutics has been gaining increasing attention as numbers of recombinant proteins are showing great therapeutic benefit. There are great challenges on immunogenicity assessment of biotherapeuticcs due to the nature of immune response and limitation and/or understanding of technologies, such as 1) lack of representative reference standard and appropriate positive control samples; 2) high level of endogenous drug interference; 3) unpredictable nature of immune response among individual; 4) limitation of analytical methods; and 5) inappropriate interpretation of the testing results. This symposium brings together some of the scientists who have been working on immunogenicity assessment of biotherapeutics to review the current and new technologies and their advantages and disadvantages on immunogenicity testing, to present real-life challenges in developing and implementing immunogenicity assays, and to share their successful approaches/strategies on immunogenicity assessment in support of biotherapeutic development.
Moderators
Patrick M. Liu, Ph.D.
Tanox, Inc.
Steve Swanson, Ph.D.
Amgen, Inc.
Emerging Technologies for Immunogenicity Assessment
Steve Swanson, Ph.D.
Amgen, Inc.
Speech Title to be Announced
Patricia Siguenza, Ph.D.
Genentech, Inc.
Drug Interference in Immunogenicity Assays: Issues, Approaches to Resolve and Other Considerations
Deborah Finco-Kent, Ph.D.
Pfizer, Inc.
*Session tentatively scheduled to be recorded
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