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Establishing and maintaining consistency and reliability of raw materials and the product throughout development stages and in the fi nal commercial process is critical and presents a challenge for complex biological systems due to multiple factors that aff ect their viability and function.The leveraging of clinical data throughout development can occur only if the drug product has similar or comparable qualities throughout development. Thus, comparability for CGT therapy products is a critical aspect of process development and is required to link clinical data throughout progressive phases of product development.Assays measuring product potency are of central importance to all product development and quality control activities. Potency assays serve many functions. They help to identify and control sources of variation in product activity and to test for product comparability across lots, process changes, sites, scale changes, and stability testing.

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