Cryopreservation is a critical processing step within therapeutic cell manufacturing. As manufacturing processes are scaled-up to achieve commercially-relevant lot sizes, there are several factors to take into account in order to successfully achieve a consistent, highly viable and biologically functional cellular product. Product viability and functionality are dependent upon several downstream processing steps including the formulation steps, the filling, the freezing, the transfer to storage, and the thaw. As manufacturing processes are scaled-up, it is critical to anticipate the process bottlenecks at each step, and to develop a final solution that is capable of maintaining product integrity with the timing needed for high volume production.Source of funding: None declared.Conflict of interest: None declared.