Cryopreservation for cell and gene therapies has long been a crucial consideration for drug developers and manufacturers. These modalities require unique formulation approaches in order to preserve their therapeutic properties at every processing step, from isolation, expansion and fill/finish to storage, transport, and administration.
Despite the value of these biologics and the innovations surrounding their therapeutic potential, the cryopreservation techniques that typify these treatment shave remained largely unchanged in several decades. The cryoprotectant dimethylsulfoxide (DMSO) remains the incumbent method for regulating ice formation during the freezing process, in spite of its relative toxicity and documented propensity for inducing irreversible chromosomal and other intracellular damage. These concerns exist alongside growing recognition from the industry that DMSO can also serve to limit pre-freeze and post-thaw incubation times, creating the potential for processing bottlenecks and product loss.