Cryopreservation for Long-term Storage in Cell-based Therapies
Being able to extend storage is considered extremely important for delivering successful cell-based therapies. Not only does cryopreservation extend shelf life, but it also helps with scaling up to increase volume.
Bongiorno suggests using cryopreservation to "pause" cell culture. Using peripheral blood mononuclear cells (PBMCs) as an example, scientists can use cryopreservation at each stage of preparation — after obtaining the blood sample, in isolating the cell type, and even following reprogramming to iPS prior to expansion.
The benefits of cryopreservation in the stem cell workflow can help mitigate some of the common problems encountered in developing cell-based therapies, namely characterization and scaling up. Cryopreservation can provide timelines with flexibility in these areas.
Scheduling flexibility is helpful, especially for clinical processing. Being able to start and stop the process not only decreases waste but also optimizes use of specialized facilities. Being able to pause cell production to fit in with the availability of a manufacturing suite, for example, is a huge benefit.
Testing flexibility means that processes can be optimized and validated before they are launched into full-scale manufacturing. Applications often require testing ahead of time. Being able to verify the quality of cell lines you are considering before committing to expansion not only saves precious resources but also allows scientists to build up a bank of qualified cell lines suitable for treatment.
Scaling Up and Expansion is essential to building sufficient volume for cell-based therapies, but it's tricky to make sure everything is ready all at once. For example, during research and development it might not be possible to predict exactly how many cells are required. In these cases, cryopreservation allows stocks to be saved for later amplification, scaling up from stock as required. Timeline flexibility also helps with supply chain challenges; with cryopreservation, you can freeze stocks and then get everything else set up and ready to go ahead of time before committing the cells.
Cryopreservation technology is evolving. Research is refining processes to support cell viability in various applications, including tissue transplantation, cell-based regenerative medicine, and organoids for drug screening. Keeping up-to-date with research and technology innovations is essential in stem cell therapies. Although there is still work to be done, Bongiorno notes that in the future, researchers may be able to cryopreserve cells following differentiation.