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Preparation of Mouse Pituitary Immunogen for the Induction of Experimental Autoimmune Hypophysitis
Published on: December 17, 2010
Report on the AAPS Immunogenicity Guidance Forum
Heather Myler1, Boris Gorovits2, Kelli Phillips3
1Immunochemistry Department, PPD Laboratories, 2244 Dabney Road, Richmond, Virginia, 23230-3323, USA. Heather.Myler@ppdi.com.
Abstract:
In September 2018, the American Association of Pharmaceutical Scientists (AAPS) conducted an Annual Guidance Forum on the considerations related to immunogenicity testing for therapeutic protein products. In addition to a broad representation by the pharmaceutical industry, the event included strong representation by leading scientists from the US Food and Drug Administration (FDA). The agency and industry perspectives and updates to the guidance were presented. Specific topics that were discussed included the strategies of anti-drug antibody (ADA) assay cut-point assessments, the selection of ADA-positive controls (PCs), and the evaluation of PC performance. Assessment strategies and relevance of ADA assay attributes were also discussed, including assay drug tolerance and ADA assay sensitivity. The following is a summary of the discussion.
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