Potency Assay Development - Creating Potential Together

Custom Potency Assay Development Ensuring Reliable Lot-to-Lot Consistency

Demonstrating the potency of a biopharmaceutical is critical to drug development and, ultimately drug marketability. Dependable chemistry, manufacturing and control (CMC) underpins the whole drug development process, avoiding costly delays through careful manufacturing, regulatory and clinical strategy. It is necessary to achieve a well-designed and developed potency assay as it is the only analytical technique that can demonstrate the biological mechanism of action (MOA) and the link to clinical efficacy.