Resource: COVID-19: Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Proteins Targeting SARS-CoV-2 Infectivity
Source: U.S. Food and Drug Administration
Synopsis: The FDA issued a temporary guidance entitled, “COVID-19: Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Proteins Targeting SARS-CoV-2 Infectivity.” This guidance describes methods that applicants should use to ensure the potency of monoclonal antibodies and other therapeutic proteins proposed for use as anti-infective agents for COVID-19. The FDA issued this guidance to help development of monoclonal antibodies and other therapeutic proteins for use as COVID-19 therapeutics."
Comment: Monoclonal antibodies have certainly found their place in the treatment of hospitalized patients with COVID-19. The aforementioned guidelines will promote greater efficacy of monoclonal antibodies. With a recent reporting of new strains of COVID-19, this will provide a greater armamentarium of monoclonal antibodies to treat various strains of COVID-19.
