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European Biopharmaceutical Review

Stay Cool

Cryopreservation is the primary method for long-term storage and the preferred modality for transportation of cell doses. It provides a number of biological and logistical advantages which include, but are not limited to; flexibility in patient scheduling, clinical operating hours and laboratory testing. Most common protocols currently include the use of serum/ protein-containing extracellular-like media supplemented with dimethyl sulfoxide (DMSO) at various concentrations, passive freezing to -80°C at -1°C/min, and then transfer to liquid nitrogen vapour storage (LN2).

This method is used to preserve cell therapeutic products after manufacturing, until thawing and administration. It is critical that evidence-based best practices (BP) are used throughout to ensure the highest post-thaw functionality of the cells. The quality of procedures used in each of these steps has a direct impact on the return-to-function of the cellular products post-thaw, whereas sub-optimal practices can subject them to stresses that negatively impact their biological function.

Cryoprotectants

For commercialised cellular products, the use of serum and other components directly derived from animals is discouraged from manufacturing and processing to mitigate source variability and minimise the risk of xenopathic disease transmission to patients (1). Consequently, well-defined Good Manufacturing Practice (GMP) media for cell culture and cryopreservation are preferred, and there is increasing demand in the developing field of cellular therapies.

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John Fink is Marketing Manager for Cryogenic Solutions at Brooks Life Science Systems. At Brooks, he has carried out novel thermal excursions research regarding sample warming rates, variables and their effects on post-thaw cell viability and recovery. John holds an MBA from Queen’s University, Canada, a Mechanical Engineering Diploma from Mohawk College, Canada, and an Associate of Health Science from Dean College, US.

As the Head of Global Operations for BioStorage Technologies, a Brooks Life Science Systems Company, Katheryn Shea is responsible for all operational aspects of the business across Asia, Europe and the US. She also provides technical leadership for specimen management, processing, storage and distribution activities and is instrumental in the development of business alliances and collaborations. Katheryn received her BS in Biology from St Mary’s College in Maryland, US, and is a well-published author on biological sample management best practices and regulations.
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