Optimized Fill And Finish To Limit DMSO's Negative Impact On T Cells

By Trevor Smith, Terumo Blood and Cell Technologies

Cryopreservation is an integral component of most cell therapy manufacturing paradigms – for any cell therapy requiring transport, employing a freeze/thaw process that ensures cell viability upon administration is a crucial operation. The cryoprotectant dimethyl sulfoxide (DMSO) has for decades served as the preferred means of regulating ice formation during the freezing process, owing to its demonstrated ability to interrupt the formation of ice crystals. Despite its documented toxicological profile and its potential negative impacts on efficacy, DMSO remains the primary cryoprotectant for these modalities.

There is growing recognition within the industry that prolonged exposure to DMSO can serve to hamper pre-freeze and post-thaw incubation times, creating the potential for manufacturing bottlenecks and product loss. Yet the superior vitrification afforded to a freezing process by DMSO, as well as its lack of competing alternatives in the market, is likely to result in its continued use for years to come. In order to improve the existing cryopreservation paradigm, operators must consider fill/finish and cryopreservation techniques that streamline processing steps and minimize cells’ exposure to DMSO.

T-cell therapies are some of the most pursued in the field, given their potential to treat intractable diseases such as cancer. As a consequence, this cell type has experienced more research into its interactions with DMSO than some others, resulting in new insights into the potential negative impacts of the cryoprotectant on these cells.