Notice of Intent to Award a Sole Source Commercial Tender - 141720923

Procurement Summary

Country: USA

Summary: Notice of Intent to Award a Sole Source Commercial Simplified Acquisition Procedures Sap Purchase Order for Metabolismqualified Cryopreserved Human Hepatocytes

Deadline: 29 May 2026

Posting Date: 21 May 2026

Other Information

Notice Type: Tender

TOT Ref.No.: 141720923

Document Ref. No.: CDER-2026-132690

Competition: ICB

Financier: Self Financed

Purchaser Ownership: Public

Tender Value: Refer Document

Purchaser's Detail

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Tender Details

The Food and Drug Administration (FDA) intends to award a Sole Source firm-fixed-price commercial Purchase Order (PO) to BioIVT, LLC (BioIVT), 1450 South Rolling Road, Baltimore, MD, 21227, for the Purchase of Metabolism-Qualified Cryopreserved Human Hepatocytes in accordance with the authority under FAR RFO Part 6.103-1, Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements.
BioIVT is the only known source capable of providing metabolism-qualified cryopreserved human hepatocytes meeting the required donor characteristics, viability thresholds, and metabolic activity specifications necessary to support continuity of the FDA research study. A Sources Sought notice was previously posted on SAM.gov and no capability statements or responses were received from interested vendors.
This acquisition is being conducted using simplified acquisition procedures in accordance with FAR RFO Part 12 for the acquisition of commercial products and commercial services.
The North American Industry Classification System (NAICS) code for the proposed acquisition is 325414; Biological Product (except Diagnostic) Manufacturing, with a small business standard size of 1, 250 employees.
Deliverables
The contractor shall provide up to 4 distinct female donor lots totaling 24 vials of cryopreserved human hepatocytes. Delivery must occur within 7 days of award.
Cryopreserved Human Hepatocytes - Donor Lot 1: Single-donor female metabolism-qualified cryoplatable human hepatocytes (Age 20-35 years), minimum viable cells/vials with 85% post-thaw viability — 6 Vials
Cryopreserved Human Hepatocytes - Donor Lot 2: Single-donor female metabolism-qualified cryoplatable human hepatocytes (Age 54-70 years), minimum 5 million viable cells/vials with 85% post-thaw viability — 6 Vials
Cryopreserved Human Hepatocytes - Donor Lot 3: Single-donor female metabolism-qualified cryoplatable human hepatocytes (Age 54-70 years), minimum 5 million vi...
Notice ID: cder-2026-132690

Department/Ind. Agency: health and human services, department of

Sub-tier: food and drug administration

Office: fda office of acq grant svcs

Product Service Code: 6505 - drugs and biologicals

NAICS Code: 325414 - Biological Product (except Diagnostic) Manufacturing

Inactive Dates: jun 13, 2026

Inactive Policy: 15 days after response date

Documents

 Tender Notice