Cell therapy is an emerging therapy with great therapeutic potential because, unlike small molecules, cells are a dynamic product. They can migrate, proliferate, differentiate, and respond to their environment both in vitro and in vivo. Cell therapy also presents challenges as well, many of which can impact manufacturing of the final product. These include a limited shelf life (from cell viability), limited availability of the starting material for process, product and test method development, small lot size, and limited sample volumes for postprocess testing, patient variability and cell heterogeneity.
