CGTs use complex biologicals, both in the manufacturing and in the final drug product, which makes them inherently variable. PotencyThis is a measurement that can be used to correlate the final drug product to clinical effect or therapeutic benefits. Developers can reduce the risk of delays and align product quality testing with regulatory expectations by identifying critical quality attributes (CQAs) for a product’s safety, efficacy and quality. Regulators want to know that a previous iteration of the drug product is comparable to the current iteration. Temperature stability is key, and regulators want assurance that the vials are not deteriorating and contaminating the drug product.