FDA Offers Advice on Potency Assays for Therapeutic Protein COVID-19 Treatments

The FDA has issued straight-to-final guidance that provides sponsors of monoclonal antibody and other therapeutic protein COVID-19 treatments with recommendations for potency assays to ensure consistent product quality.

The guidance describes various potency assay methods for sponsors to consider. For example, although binding assays — which measure interactions between two molecules — will generally suffice as potency assays at the Investigational New Drug stage of development, the FDA notes that they only assess a single aspect of product potency.

The agency advises sponsors to also develop methods that more broadly monitor the products’ proposed mechanisms of action. These should be incorporated into drug substance and drug product release testing as well as in stability protocols. Additionally, all potency assays should be described, justified, qualified and validated in order to support a Biologics License Application, the guidance says.

The guidance does not cover vaccines, hyperimmune globulins, gene therapies, cell therapies or convalescent plasma.

Read the final guidance here: www.fdanews.com/01-14-21-COVID19.pdf. — James Miessler