Metabolism Qualified Cryopreserved Human Hepatocytes

The Food and Drug Administration (FDA) is seeking information from qualified small business sources for the provision of metabolism-qualified cryopreserved human hepatocytes and associated materials. The objective is to support mission-critical regulatory science research. The supplier is required to provide protocol(s) for the thawing, plating, and culturing of hepatocytes, including media composition and source. The contractor shall provide 24 total vials of cryopreserved human hepatocytes from 4 different female donors, along with associated materials such as thawing media, incubation/culture media, and antibiotic mix. • The hepatocytes must meet specific donor requirements, including age, HIV and Hepatitis B/C status, and CMV and EBV test results. • The cells must meet cell quality requirements, including viability, metabolism qualification, and plateability. • The contractor must provide documentation, including a Certificate of Analysis, donor information, metabolism activity data, and biosafety information. • The contractor must provide protocol documentation, including thawing procedures, plating procedures, culture conditions, and media composition and sourcing. • The shipment must maintain product integrity using dry ice or liquid nitrogen, and delivery must occur within 7 days of award.