Office of Clinical Pharmacology / Division of Applied Regulatory Science (DARS) – Critical DARS Laboratory Supplies

The government is purchasing up‑to‑72 vials of cryopreserved human hepatocytes from female donors, with specific age‑group and functional qualifications for metabolism and/or transporter studies. Offerors must submit PDF protocols for thawing, plating and culturing the hepatocytes (including media composition and sources) to the FDA contact before shipping any vials. The notice requires the supplier to choose a qualification pathway—either metabolism‑qualified (CYP enzymes) or transporter‑qualified (OATP/other transporters)—and to provide cells from either six donors (single qualification) or twelve donors (combined qualifications) as described. No additional location, set‑aside, or performance period constraints are noted.

Notice ID

f2263abf750a489983a26a48b50ad839

Solicitation Number

FDA-CDER-25-130555

NAICS Code

541714

Classification Code

AJ12