One of the major challenges of delivering a patient-specific cell therapy is that fresh cells for modification are usually only viable for about one to three days from the time of collection. Considering the transit time that it takes for cells to reach the therapy manufacturing facility, this can be a severe limiting factor for the viability of the whole manufacturing process. Additionally, the final product cells also have a limited period of viability.
This is why many cell therapy developers are focusing so much effort on the cryopreservation of cells in their shipping processes. By freezing the cellular starting material and the final product cells, therapy manufacturers can greatly extend the viability of the cells—increasing the geographic reach of their cell therapy products.
However, one common question that cell therapy developers have is “does cryopreservation affect the quality of my cell therapy product?” The short answer is “yes.”
The real question is “how does cryopreservation affects therapeutic cells in a patient-specific process?”
The Big Concern with Preserved Cells
Freezing therapeutic cells can substantially alter their characteristics—and in non-obvious ways. For example, therapeutic cells can appear healthy after they are thawed, but may not expand as well as cells that were never frozen. This can cause the final product to not work as expected or to produce a smaller than expected dose.
The risk of damage to preserved cells can vary depending on the process and specific type of cell being frozen. For example, as noted in a report featured in Science Direct, it was shown
“that cryopreservation does not affect the long-term expression of TRAIL and that cryopreserved TRAIL-expressing MSCs exhibit similar levels of homing and, importantly, retain their potency in triggering cancer cell death.”
These mesenchymal stromal cells (MSCs) were largely unaffected by the cryopreservation method used in the study.
However, in another study featured on PLOS, it was noted that
“short-term storage of placental MSCs at subnormothermic condition ensured the preservation of cell number, viability and cultural properties with 48 hours whereas further increase of the storage period at this temperature led to significant loss of both cell number and viability.”
Is Cryopreservation Worth the Effort?
Cryopreservation can be enormously beneficial to a cell therapy manufacturing process for a number of reasons—making it well worth the effort to at least test its use in almost any patient-specific cell therapy product. For nonspecific, off-the-shelf cell therapies, cryopreservation is an obvious choice because of the sheer number of doses being prepared for future use.
The big benefit of cryopreservation of cell therapies is that it allows you to decouple the actual manufacture/delivery of the cell therapy from the initial collection. Normally, manufacturing facilities would have to sit idle whenever demand is low—consuming resources without providing a benefit. By using cryopreservation, it’s possible to move some of the peak demand manufacturing into the periods of time where demand is lighter. This helps offset the risk of wasting resources on idle manufacturing facilities and allows for more patients to be treated because there’s a wider window of opportunity for collecting and manufacturing cell therapies.
This, in turn, helps patient-specific cell therapies reduce their cost of goods (COGs)—helping to improve the commercial viability of the therapy product.
Cell therapy developers can further improve their COGs by partnering with third-party manufacturing partners that use reliable and well-established cryopreservation techniques in their cGMP-compliant manufacturing infrastructure and systems. These third-party partners help to further reduce the risk of idle manufacturing capacity costs and may have partnerships with carrier fleets to maximize distribution speed and efficiency for cell therapy products.
Is cryopreservation the right choice for your own cell therapy product? For more information please read our whitepaper, “The Cold Truth: Cryopreservation of Final Product in Cell Therapy Manufacturing!” Or, contact us directly!
