Analytical considerations for cellular therapy manufacturing

The commercialization of cell-based products presents unique challenges. An evolving regulatory landscape, rapid advances in manufacturing technologies, products with complex mechanisms of action (MOA) and inherent variability in starting cellular material are just a few examples of these challenges. The availability of relevant analytical tools is important in manufacturing and process development, where they are used to control the product and to enable process changes. When considering process changes, cellular therapy manufacturers seek to apply sound engineering principles, develop good process understanding and use meaningful analytical methods for product characterization. The diversity and complex nature of cell therapy products requires an increasingly broad set of analytical tools to assist in this endeavor. Scientists engaged in assay development are challenged to select the most appropriate methods and adapt these assays to a quality environment. Cell and patient variability, multiple MOAs, lack of reference materials and complex analytical methods and instruments underlie some of the technical difficulties. This article discusses the testing strategies used by cell therapy manufacturers throughout the product development lifecycle as well as solutions to commercial challenges such as method validation, automation and potency assay development.