Potency analysis of cellular therapies: the role of molecular assays

Abstract All cellular therapy products must be demonstrated to be safe, pure, potent, stable, and effective for human use. Potency is a measure of the critical biological properties of a product, and measuring the potency of cellular therapies is very challenging. The potency of most cellular therapies is dependent on multiple functions, some of which may not be known. Biological variability in the starting material and variability in complex manufacturing processes also increase the difficulty in measuring cell therapy potency. Despite these difficulties, measuring potency is one of the most important aspects of assessing cellular therapy products. All products should meet established minimal levels or ranges of potency. and potency levels should be consistent across manufacturing lots. Potency measures are also used to ensure that product effectiveness is maintained as manufacturing methods are scaled up and out.