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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 conducted using simplified acquisition procedures for commercial products and services. The agency determined that BioIVT is the only source capable of providing the specific donor characteristics, viability thresholds, and metabolic activity specifications required to maintain the continuity of an ongoing FDA research study. This requirement is classified under NAICS code 325414, Biological Product (except Diagnostic) Manufacturing, and PSC 6505, Drugs and Biologicals. No set-aside was used for this procurement.
The scope of work includes the delivery of 24 vials of cryopreserved human hepatocytes across four distinct female donor lots, categorized by specific age ranges and a minimum post-thaw viability of 85%. Additional deliverables include cell culture media, antibiotic reagents, domestic cryogenic shipping, and technical documentation such as certificates of analysis and protocols. Delivery is required within seven days of award at a performance location in the United States.
Responses to this special notice are due by 5:00 pm ET on May 29, 2026, and must be submitted to the designated point of contact, Shavone Jeter, or secondary contact Craig Wright. While this notice is not a request for competitive quotes, firms may submit capability statements to demonstrate their ability to meet the requirements. The government maintains sole discretion in determining whether to compete the requirement based on any responses received. There are currently zero attachments associated with this notice.
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