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U.S. Department Of Health And Human Services·Maryland

Notice of Intent to Award a Sole Source Commercial Simplified Acquisition Procedures (SAP) Purchase Order for Metabolism-Qualified Cryopreserved Human Hepatocytes

Closes 5/29/2026$20k – $100kSole Source
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Description

The Food and Drug Administration (FDA) intends to award a sole source firm-fixed-price commercial purchase order to BioIVT, LLC for the purchase of metabolism-qualified cryopreserved human hepatocytes. The contractor shall provide up to 4 distinct female donor lots totaling 24 vials of cryopreserved human hepatocytes, with specific requirements for each donor lot. The deliverables also include cell culture media, antibiotic reagent, shipping requirements, and technical documentation. * The contractor must provide cryopreserved human hepatocytes with specific donor characteristics, viability thresholds, and metabolic activity specifications. * The contractor must deliver the products within 7 days of award. * The contractor must provide technical documentation, including a certificate of analysis and protocols for thawing, plating, culturing, and media preparation.

Attached files

The solicitation documents live at the source — open the bid source above to download them.

Contact

Craig Wright

[email protected]

Key dates

Opened
5/20/2026
Questions due
5/29/2026
Closes
5/29/2026
Duration
7 days

Last updated

Details

Type
Sole Source
Industry
Healthcare and Medical Services
NAICS
325414
Solicitation №
CDER-2026-132690

Budget estimate

$20,000 – $100,000

The budget for this contract can be estimated based on the products and services required. The contractor must provide up to 24 vials of cryopreserved human hepatocytes, cell culture media, antibiotic reagent, and technical documentation. The cost of these products and services can vary depending on the supplier and the market. However, based on industry standards, the cost of cryopreserved human hepatocytes can range from $500 to $2,000 per vial, depending on the quality and characteristics of the cells. The cost of cell culture media and antibiotic reagent can range from $50 to $500 per unit, depending on the type and quality of the products. The cost of technical documentation and shipping can range from $100 to $1,000, depending on the complexity of the documentation and the shipping requirements. Therefore, the total budget for this contract can be estimated to be in the range of $20,000 to $100,000.

AI estimate from the solicitation

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