Potency testing

Potency assays are used to measure the biological activity and effectiveness of a drug product, particularly biologic drugs like vaccines, monoclonal antibodies, and gene therapies. The primary goal of a potency assay is to ensure that the drug performs its intended function at the required level of activity. These tests can be used for product evaluation as early stages of drug development (screening) or submitted to regulatory authorities as part of Chemistry, Manufacturing and Controls (CMC).

As mentioned, potency assays are crucial since they are used to confirm that the biologic product can achieve the desired therapeutic effect. For this reason, regulatory agencies such as the FDA (Food and Drug Administration) and EMA (European Medicines Agency) require potency assays as part of the approval process for biologics. These tests demonstrate that the product is consistently effective and safe.