Nucleated cell content, because it is easily measured and applied across laboratories, is a common measure for dosage. However, this parameter does not directly reflect functionality of the cellular components. Traditional clonogenic assays such as the colony-forming unit assay (CFU) indicate cellular potency but are subjective, and to date, not well standardized. Diverse sample types used to represent cellular therapy products at various phases of manufacture further complicate testing and application of results. During this session, presenters will examine the less tangible features of potency testing that may positively influence standardization. Participants will also approach potency as it relates to release testing and how manufacturers can promote regulator and consumer confidence in their products.