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.
