Potency Assays for Engineered Cell Therapies – Challenges and Opportunities

Engineered cellular therapy products are among the more complex of immunotherapeutic modalities because they are living drugs. Cell-based potency assays are essential to demonstrate that drug product activity is linked to biological critical quality attributes. However, key challenges continue to include an incomplete understanding of CQAs, lack of universal controls, limited lot sizes for use in development, and identifying and mitigating sources of variability in cell-based potency assays. Fortunately, early use of phase-appropriate, risk-based approaches to method development, qualification/validation, and analytical control strategies from clinical stages through to commercialization can ease regulatory burdens.