Strategies to Enhance Stability of Cryopreservation Processes for Cell-Based Products

The projected expansion of the global market for cell manufacturing, which contributes to regenerative medicine and cell therapies, warrants the designing and development of scalable cryopreservation processes for cell-based products (CBPs) for use in both standard and personalized therapies. However, the change in scale causes variations in process parameters, which affects the stability of the CBP quality. Therefore, the cryopreservation process for CBPs needs to be designed based on the concept of cell manufacturability and consideration of both engineering and biological aspects. In this review, we discussed strategies to enhance the quality stability of CBPs during cryopreservation, focusing primarily on four key processes: dispensing, freezing, storage, and thawing. Additionally, we discussed the application of simulation technologies because they aid in constructing digital twins for the designing and development of the cryopreservation process and facilitate efficiency with limited time and resources.