FDA Issues Guidance on Potency for mAbs and Therapeutic Proteins

FDA issued guidance on March 2, 2023 to provide recommendations to sponsors that help in the creation of monoclonal antibodies (mAbs) and other therapeutic proteins that target viral proteins or host cell proteins that interfere with pathogenic mechanisms of infection. A critical quality control measure for these products is the implementation of a potency assay(s) adequate to make sure that each lot is produced consistently with the potency necessary to reach clinical efficacy and that the potency is maintained over the shelf life of the product.

The new guidance provides detailed recommendations to drug developers with a target of helping to ensure that drug developers provide adequate information to assess potency at each stage of a product’s life cycle. Further, it describes approaches that sponsors should use to develop potency assay methods for release and stability that assess comprehensively known or potential mechanism(s) of action of the product. It also describes methods that sponsors should use to ensure the potency of mAbs and other therapeutic proteins intended to prevent or treat a viral infection.