Storage and Delivery of Stem Cells for Cellular Therapies

One of the biggest challenges for the commercialization of stem cell therapies (SCTs) is securing the therapeutic potential of the cells. This requires cellular preservation to be managed throughout the process to ensure a quality and efficacious product is delivered to the patient. This chapter explores the cell preservation challenges that may be encountered when manufacturing SCTs at a commercial scale, including the formation of cell banks, interprocessing pooling, final product preservation, distribution, and point-of-care processing. The need for comprehensive biological and process knowledge and control, in order to produce a consistent therapy, is examined. Possible approaches to address these challenges such as implementation of technology, methods of risk management, and advanced process development planning are discussed, while acknowledging potential restrictions including regulatory guidance and clinical limitations.