Cell Measurements for Regenerative Medicine: How thinking about product development can lead to better science through better measurements

Successful production of a biological therapy requires reliable measurements of the desired characteristics of the putative product at every stage, including development, manufacturing and release. Demonstrating that the product is comparable from batch to batch is key to successful manufacturing and regulatory approval, and this requires establishing that measurements are comparable. For these complex therapies a daunting challenging is identifying those measurements that are effective predictors of the potency and safety of the product. We are developing imaging technologies to help further the understanding and characterization of complex cellular systems. Not only are good measurement practices essential in product development and characterization, they are equally important for assuring the value of research results.