Freeze it and forget it: the value of having a robust formulation and cryopreservation strategy for cell therapy manufacturing
With over 500 cell therapies in clinical development and a further 1000 studies underway, cell therapies are becoming an increasing topic of discussion, particularly when considering bench-to-bedside translation. Given that these therapies are living pharmaceuticals, this has brought about complex post-manufacturing challenges in formulation, final fill and cryopreservation.
To ensure successful commercialization of cell therapies, these post-manufacturing steps must be ironed out. For example, the final cryopreserved products must have an extended shelf life, be conductive to long-term storage and withstand global transportation. Developing a standardized strategy for cryopreservation is challenging due to the diversity of cell types, nature of therapy and the size of the dose. Therefore, it is vital to design processes that overcome the complexity and protect final product integrity.
In this review, learn more about the challenges related to cryopreservation of cell-based therapies, along with formulation and final fill. Additionally, read more about the lessons learned from recent commercial successes and what best practices can ensure product safety.
This content was supplied by Thermo Fisher Scientific.