How does a researcher properly design and sequence new assays to match the changes in product and regulatory oversight throughout the entire life cycle from preclinical to clinical? It directly contrasts the efficacy and sensitivity of different assay types throughout the different phases and recommends best practice in sequencing. In the presentation The Evolving Approach to Immunogenicity Assay Development and Validation, Don Zhong, Senior Scientist, Clinical Immunology of Amgen will discuss these challenges that are ever-present challenge for the bioanalytical researcher.Featured Session: The Evolving Approach to Immunogenicity Assay Development and Validation
Featured Speaker: Don Zhong, Senior Scientist, Clinical Immunology, AMGEN
About the session: During the development of trebananib (AMG 386), we have adopted an evolving approach to immunogenicity assessment of the molecule. While a bridging assay was validated to support the early phase clinical studies, a Biacore¬ assay was found to be more suitable for late stage clinical trials, capable of confirming detection of antibodies having diverse affinity, epitopes and isotypes in the presence of higher levels of circulating drug. The Biacore¬ assay allows us to better assess the potential impact of immunogenicity on pharmacokinetics, pharmacodynamics and safety of the molecule.
Immunogenicity for Biotherapeutics will take place March 18-20, 2013 in Baltimore Maryland. For more information on this session and the entire event, download the agenda. If you'd like to join us in Baltimore register today and mention code XP1838BLOG to save 15% off the standard rate!
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