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Notice of Intent to Award a Sole Source Commercial Simplified Acquisition Procedures (SAP) Purchase Order for Metabolism-Qualified Cryopreserved Human Hepatocytes
Contact and place of performance
Craig Wright
USA
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....
View moreDeliverables
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.
Responses
Responses to this notice should be sent to Shavone Jeter at [email protected] no later than 5:00 pm (ET) on May 29, 2026. This notice is not a request for competitive quotes. Any other firms desiring consideration must fully identify their interest and capability of meeting the requirements by submitting a capability statement. Any response shall undergo review to determine if it can meet the requirements. A determination by the Government not to compete this proposed requirement based upon a response to this notice is solely within the discretion of the Government.
The Food and Drug Administration (FDA) intends to award a sole-source, firm-fixed-price purchase order to BioIVT, LLC for metabolism-qualified cryopreserved human hepatocytes. This acquisition, identified under solicitation number CDER-2026-132690, is being conducted via simplified acquisition procedures for commercial products. The requirement is classified under NAICS 325414 Biological Product (except Diagnostic) Manufacturing and PSC 6505 Drugs and Biologicals. There is no set-aside designated for this procurement. BioIVT is cited as the only source capable of providing donor-specific materials and metabolic activity specifications required to maintain the continuity of an ongoing FDA research study following a previous sources-sought notice that yielded no responses.
The scope of work involves the delivery of 24 vials of cryopreserved human hepatocytes across four distinct female donor lots, categorized by specific age ranges and post-thaw viability thresholds of at least 85 percent. The order includes single-donor lots for one female aged 20–35 and three females aged 54–70, alongside necessary cell culture media, antibiotic reagents, and domestic cryogenic shipping. The contractor is required to provide technical documentation including certificates of analysis for each lot and complete protocols for thawing, plating, and culturing.
Performance will take place in the United States, with all deliverables due within seven days of the contract award. Although the FDA does not intend to compete this requirement, firms may submit capability statements for review by May 29, 2026, at 5:00 pm ET. Responses and inquiries regarding this notice are directed to Craig Wright and Shavone Jeter. There are currently zero attachments associated with this special notice.
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