Monoclonal Antibody Potency Assay Guidance

FDA has published a draft guidance, Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Proteins Targeting Viral Pathogens, giving sponsors recommendations to assist in the development of monoclonal antibodies and other therapeutic proteins that directly target viral proteins or host cell proteins mediating pathogenic mechanisms of infection. The document says a critical quality control measure for such products is the development and implementation of a potency assay adequate to ensure that each lot is produced consistently with the potency necessary to achieve clinical efficacy and that such potency is maintained over the product’s shelf life.

The guidance is said to provide detailed recommendations to drug developers to help to ensure that they provide adequate information to assess potency at each stage of a product’s life cycle.