Understanding and mitigating risks associated with cryopreservation practices in cell therapy

Cryopreservation is a critical component of the cell therapy supply chain, directly influencing the quality, consistency, and therapeutic potential of cell-based products. Despite its importance, cryopreservation is often overlooked or pushed to the very end of process development, leading to variability, reduced product yield, and increased risk of batch failure. This article identifies areas of risk, including: cryoprotectant formulation, container selection, control of the freezing and thawing processes, timing, and cell handling protocols. It highlights how improvements in these areas can reduce costs, enhance process efficiency, and improve post-thaw recovery and functionality. Beyond the elements described above (reagents, equipment, containers), the human element is important. There must be an investment in education about the scientific principles of preservation, training on proper protocol execution, and auditing to ensure protocol adherence. These core elements can reduce the risk associated with cryopreservation of a cell therapy product and ensure consistent outcome.

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