Cell-Based Bioassays For Potency Testing: From Assay Design To GMP Readiness

Cell‑based bioassays have become essential for demonstrating the potency and functional relevance of today’s most advanced therapies. This resource provides a clear, practical overview of how developers can navigate the full journey from early assay concept to GMP‑ready execution. It explains the foundational elements behind successful bioassay design—defining the right biological question, selecting a meaningful cell model, identifying measurable endpoints, and pairing them with reliable analytical readouts.

The guide also highlights the scientific and operational challenges that make CBBAs uniquely complex, from cellular variability and autologous therapy constraints to capturing multifactorial mechanisms of action. Readers gain perspective on how to strengthen assay robustness with modern QC tools and how to approach regulatory expectations, particularly as potency requirements continue to evolve. For teams working in biologics, cell therapies, or gene therapies, this preview offers a concise roadmap toward more dependable, regulator‑ready bioassays.