Can HypoThermosol® or CryoStor® be used in clinical applications?Published: March 11, 2019
Our biopreservation media, CryoStor® and HypoThermosol®, are utilized by a number of cell therapy groups (currently approximately 250+ regenerative medicine applications). We have a number of clinical customers that also use the solutions as excipients without wash for patient application of their cell therapies. The media solutions are not classified as drugs or devices, and therefore do not carry specific therapeutic regulatory approvals. Within their classification as ancillary materials in a customer process (or excipient if utilized in this manner by a customer), they are reviewed within the context of the customer process. Each group certainly needs to appropriately qualify the ancillary or excipient usage within their specific cell product application, but we can provide you with some clinical supporting information for your review. For clinical applications, there are several models being utilized by customers relevant to CryoStor® and HypoThermosol®:
- Thaw of cell product at bedside, and then infuse. The solution is the vehicle solution for the cell therapy product with no dilution.
- Thaw of cell product in the lab or bedside, and then diluted with isotonic solution. There is no wash step so cells are not lost, and biopreservation media is diluted before administration.
- Thaw of cell product in the lab, and then diluted (or washed and resuspended) in HypoThermosol® – this is more of a model when one does not want the bedside thaw but needs to ship/hold the product for a significant number of hours where the cell product loses stability.
- HypoThermosol® for non-frozen stability of source material (apheresis, bone marrow, tissue biopsy) and/or final cell/tissue product at 2-8°C.
- CryoStor® for frozen stability of source material (apheresis, bone marrow, tissue biopsy). BioLife Solutions has also consolidated information regarding the wide breadth of customer clinical applications.
Within the Evidence Page on our website, there is a list of customer clinical applications using CryoStor® and HypoThermosol®, including if utilized as an excipient. Please visit us at http://www.biolifesolutions.com/evidence/ and click the “BioPreservation Media Products in Customer Clinical Trials” tab for the most current list.