FDA has issued the draft guidance “Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Proteins Targeting Viral Pathogens." This guidance provides drug manufacturers with recommendations for developing and implementing potency assays to ensure each lot of monoclonal antibodies (mAbs) or other therapeutic proteins is produced consistently with the potency necessary to achieve efficacy and that potency is maintained over the shelf life of the product.
In January 2021, FDA published a guidance specific to potency considerations for mAbs and therapeutic proteins targeting SARS-CoV-2 (the virus causing COVID-19). This draft guidance expands the scope of the January 2021 guidance to include all mAbs and other therapeutic proteins targeting viruses, not just mAbs targeting SARS-CoV-2.
Subscribe to our e-Newsletters
Stay up to date with the latest news, articles, and events. Plus, get special offers
from American Pharmaceutical Review – all delivered right to your inbox!
Sign up now!