Autologous T-cell therapies no longer are limited to small, single-site trials. National and international demand is growing, bringing with it the demand for rapid scaling of manufacturing. But there is little margin for error, because any variables in an end-product could result in a potentially hazardous change to a therapy’s potency.

Cryopreservation is a critical tool for quality control and transport of cells. Liquid nitrogen (LN₂)–based controlled-rate freezers have long been used to freeze clinical-grade T cells. Cells are frozen in either cryogenic vials or bags, using LN₂ to cool them at –1 °C/min to a desired temperature. Cryopreserved cells then can be transported
or stored long term. Unfortunately, use of liquid nitrogen creates a safety risk of oxygen depletion in the room where it is used. Therefore, appropriate infrastructure and safety
systems must be installed within a cleanroom environment. This can be expensive and cumbersome.

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