FDA Announces Availability of COVID-19 Guidance – Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Proteins Targeting SARS-CoV-2 Infectivity

FDA | CDER | Small Business and Industry Assistance INDUSTRY NEWS . FDA Announces Availability of COVID-19 Guidance – Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Proteins Targeting SARS-CoV-2 Infectivity   Today, the U.S. Food and Drug Administration is announcing the availability of a guidance entitled, "COVID-19: Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Proteins Targeting SARS-CoV-2 Infectivity." FDA is issuing this guidance to assist sponsors in the development of monoclonal antibodies (mAbs) and other therapeutic proteins for use as COVID-19 therapeutics and to provide more detailed recommendations to drug developers with the goal of facilitating more complete submissions. The guidance describes how potency assay methods required for release and stability testing can be shown to assess comprehensively known or potential mechanism(s) of action of the product. The testing methods should also be sufficiently sensitive to demonstrate lot-to-lot consistency. In addition to release and stability methods, additional methods that demonstrate the biological function(s) of the product may be needed for characterization and comparability studies. This guidance applies only to mAbs and other therapeutic proteins designed to bind to viral receptors on host cells, inhibit viral entry, and/or elicit Fc-mediated effector function. This guidance does not apply to vaccines, hyperimmune globulins, gene therapies, cell therapies,  convalescent plasma and other non-therapeutic medical products.     The Small Business and Industry Assistance program in the Center for Drug Evaluation and Research (CDER SBIA) provides guidance, education and updates for regulated industry. Register for Upcoming Training Watch Learning Library Recordings on YouTube Subscribe to CDER SBIA Email Updates Follow on LinkedIn Follow on Twitter   This is an automated message delivery system. Replying to this message will not reach the CDER SBIA staff. If you have comments or questions, contact us at CDERSBIA@fda.hhs.gov or 1-866-405-5367 or (301) 796-6707.   SUBSCRIBER SERVICES: Manage Subscriptions  |  Unsubscribe All  |  Help

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