Adopting new cryopreservation solutions in a GMP setting can be straightforward. New agents are often designed as "plug-and-play" replacements for DMSO, used at identical concentrations, and supported by GMP manufacturing and a Drug Master File to simplify the transition.
The non-toxic nature of new cryopreservation agents allows direct injection post-thaw, removing the need for a wash step required with DMSO. This reduces contamination risk, simplifies workflows, and facilitates easier distribution and administration of cell therapies at the point of care.
The technology behind new cell cryopreservatives also enables short-term (3-5 days), ice-free cold storage of complex structures like organoids and organs. This overcomes a major hurdle in their transportation and use, as they traditionally cannot be frozen or held for long periods.
Unlike DMSO which requires rapid processing within hours, new solutions allow cells to be held for up to 24 hours before freezing without viability loss. This significantly simplifies scheduling and logistics for large-volume cell therapy manufacturing, reducing workflow pressures.
Beyond simple viability metrics, cells cryopreserved in DMSO can exhibit a significant growth lag post-thaw. In one MSC example, this resulted in a four-day delay and a 2.5-fold lower overall cell yield compared to a novel cryopreservative, highlighting a hidden manufacturing inefficiency.