Report on the AAPS Immunogenicity Guidance Forum.

Authors:
Heather Myler
Heather Myler
Bristol-Myers Squibb
Boris Gorovits
Boris Gorovits
Collegeville
United States
Kelli Phillips
Kelli Phillips
Sensory Neuroscience Research Center
Morgantown | United States
Viswanath Devanarayan
Viswanath Devanarayan
Clinical Immunology
United States
Adrienne Clements-Egan
Adrienne Clements-Egan
Biologics Clinical Pharmacology
United States
George R Gunn
George R Gunn
Department of Microbiology and the University of Pennsylvania Cancer Center
United States
Susan Kirshner
Susan Kirshner
University of Colorado Health Sciences Center
United States

AAPS J 2019 Apr 16;21(4):55. Epub 2019 Apr 16.

Pharmaceutical Consultant, North Potomac, Maryland, 20878, USA.

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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Source
http://link.springer.com/10.1208/s12248-019-0328-8
Publisher Site
http://dx.doi.org/10.1208/s12248-019-0328-8DOI Listing
April 2019
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