The Cold Truth: Cryopreservation Of Final Product In Cell Therapy Manufacturing

In hospital and small academic settings where early phase cell therapy development often takes place, it is quite feasible to manufacture a product, carry it down the hall, and infuse it into a patient. It makes both economic and logistical sense to do so. However, once a cell therapy advances to a late-stage clinical or commercial product with potentially thousands of doses a year to be shipped to hospitals all over the world, logistics become a top priority. This is where final product cryopreservation comes in.

Due to the inherently short shelf life of patient specific cell therapies, the process is prone to significant timing risks. Shipping and final delivery to the patient can be delayed by traffic, weather conditions, insufficient resources to support rapid turnaround lot release, and the availability of the patient, any of which could cause product expiry. Once a developer has gone through the intensive time and expense of manufacturing a cell therapy, failing that product at the very end of the process because it has expired before it can be administered could be catastrophic. Such a scenario is devastating to the patient, of course, but additionally, the cost of every failed product ends up being built into the cost of goods for successful products. The cost of a failed product in the administration phase is the most expensive point in the manufacturing process for a failure to occur. That is a very clear rationale for any cell therapy manufacturer to consider cryopreservation of final product.

In this article, review the benefits of cryopreservation of final product and the risks and challenges.