The biological activity of biopharmaceutical compounds (such as peptides, monoclonal antibodies, growth factors, and cytokines) has a direct bearing on their potency, which is a critical quality attribute and a representation of efficacy. For biopharma companies, measuring a cell’s bioactivity is important when: • Screening compounds to develop the lead candidate; • Validating potency when applying for regulatory approval; • Confirming that the biological characteristics of the productremain consistent throughout the development cycle andfrom lot-to-lot, or site-to-site; • Controlling for a compound’s quality prior to productrelease (either for a clinical trial or commercialization); • Testing for stability; and • Demonstrating biosimilarity between a biosimilar and theoriginator compound. 2795

White Paper: CMC Measuring Biological Activity Of Biopharmaceuticals With …