Metabolism Qualified Cryopreserved Human Hepatocytes
Overview
Buyer
Place of Performance
NAICS
PSC
Set Aside
Original Source
Timeline
Qualification Details
Fit reasons
- NAICS alignment with historical contract wins in similar service areas.
- Scope strongly matches core technical capabilities and delivery model.
Risks
- Past performance thresholds may require one additional teaming partner.
- Potential clarification needed on staffing minimums before bid/no-bid.
Next steps
Validate eligibility requirements, assign capture owner, and schedule partner outreach to confirm teaming strategy before submission planning.
Quick Summary
The U.S. Food and Drug Administration (FDA) is conducting a Sources Sought to identify qualified small businesses capable of providing Metabolism Qualified Cryopreserved Human Hepatocytes and associated materials. This market research aims to determine the appropriate acquisition method, including potential set-asides, for supporting critical regulatory science research at the FDA's Division of Applied Regulatory Science (DARS). Responses are due May 8, 2026.
Scope of Work
The FDA requires metabolism-qualified cryopreserved human hepatocytes from four distinct female donors (one aged 20-35, three aged 54-70), totaling 24 vials. These cells must meet specific quality standards, including minimum 5 million viable hepatocytes per vial, ≥85% post-thaw viability, and metabolism qualification for key CYP enzymes (CYP1A2, CYP2B6, CYP2C9, CYP2C19, CYP2D6, CYP3A4). They must also be plateable in multi-well plates and functional for 4-5 days post-plating.
The supplier will also provide:
- Associated materials: Thawing media, incubation/culture media, and antibiotic mix (if applicable).
- Protocol documentation: Thawing, plating, and culturing procedures, including media composition and sourcing, in PDF format prior to shipment.
- Donor and Cell Documentation: Certificate of Analysis, donor information (age, sex, race/ethnicity, cause of death, substance use, liver conditions), metabolism activity data, and biosafety information for each donor lot.
Contract & Timeline
- Type: Sources Sought / Market Research
- NAICS: 325414 (Biological Product (except Diagnostic) Manufacturing)
- PSC: 6505 (Drugs and Biologicals)
- Set-Aside: None specified (seeking small business information to determine potential set-aside)
- Response Due: May 8, 2026, 9:00 PM ET
- Published: May 4, 2026
- Period of Performance: Six (6) months from date of award.
- Delivery: Within 7 days of award, Monday-Friday (9:00 AM – 3:00 PM), to FDA Silver Spring, MD.
Response Requirements
Interested parties should submit a Capability Statement (maximum 10 pages) detailing their ability to meet the specified requirements. Responses must also include the company's business size status (e.g., small business, 8(a), HUBZone) and SAM.gov Unique Entity Identifier (UEI) number.
Additional Notes
This is a Sources Sought notice for information gathering only and is not a solicitation. The Government is not obligated to award a contract or pay for information provided. Questions will not be entertained.