The National Institutes of Health Clinical Center intends to award a sole-source firm-fixed-price purchase order to BioLife Solutions for CryoStor® CS10, 100 mL bags, with a quantity of 80 bags required for cell therapy manufacturing. The product is used by the Center for Cellular Engineering to cryopreserve FDA-regulated cell therapy products for NIH clinical trials and has been validated for use in their manufacturing processes. CryoStor® CS10 is the only commercial cryoprotectant with an FDA Master File, and substituting another product would require costly revalidation and cause delays. Performance will occur at the NIH Clinical Center in Bethesda, Maryland. Responsible sources may submit capability statements for consideration, though the decision not to compete remains solely with the Government.