Notice of Intent to Award a Sole Source Commercial Simplified Acquisition Procedures (SAP) Purchase Order for 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 Food and Drug Administration (FDA) has issued a Notice of Intent (NOI) to award a Sole Source firm-fixed-price commercial Purchase Order to BioIVT, LLC for Metabolism-Qualified Cryopreserved Human Hepatocytes. This acquisition is justified under FAR 6.103-1, citing BioIVT as the only known source capable of meeting the specific requirements for an FDA research study. Responses from other interested firms are due by May 29, 2026.
Scope of Work
The requirement is for up to four distinct female donor lots, totaling 24 vials, of metabolism-qualified cryopreserved human hepatocytes with specific age ranges (20-35 years and 54-70 years), minimum viable cells/vials, and >85% post-thaw viability. Key deliverables include:
- 24 vials of cryopreserved human hepatocytes across 4 donor lots.
- Cell Culture Media (INVITROGRO HI and CP Medium).
- TORPEDO Antibiotic Mix.
- Domestic cryogenic shipping container.
- Technical documentation, including Certificates of Analysis (COAs) and comprehensive protocols. Delivery must occur within 7 days of award.
Contract & Timeline
- Type: Sole Source, Firm-Fixed-Price Commercial Purchase Order (Simplified Acquisition Procedures)
- Intended Awardee: BioIVT, LLC
- Justification: Only known source meeting required donor characteristics, viability, and metabolic activity for FDA research continuity. A previous Sources Sought notice received no responses.
- NAICS: 325414 (Biological Product (except Diagnostic) Manufacturing)
- Response Due: May 29, 2026, 5:00 PM ET
- Published: May 20, 2026
Action Items
This notice is not a request for competitive quotes. Firms believing they can meet the requirements must fully identify their interest and capability by submitting a capability statement for review. The government's determination not to compete this requirement based on a response is solely at its discretion.