No attachments available.
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 firm-fixed-price sole source purchase order to BioIVT, LLC for metabolism-qualified cryopreserved human hepatocytes. This acquisition, identified under solicitation number CDER-2026-132690, is categorized under NAICS code 325414 for Biological Product (except Diagnostic) Manufacturing and PSC 6505 for Drugs and Biologicals. The government has designated this requirement with no set-aside, applying code NONE. BioIVT is identified as the only source capable of providing donor lots with the specific viability thresholds and metabolic activity specifications required to maintain the continuity of an ongoing FDA research study.
The scope of work requires the delivery of 24 vials of cryopreserved human hepatocytes across four distinct female donor lots, categorized by age groups of 20–35 years and 54–70 years. Each lot must meet a minimum viability threshold of 85 percent post-thaw. Additional deliverables include specific cell culture media, antibiotic reagents, and technical documentation such as Certificates of Analysis and protocol packages for thawing and culturing. All materials must be delivered within the United States using a domestic cryogenic shipping container for temperature-controlled transit within seven days of the award.
This notice is issued under simplified acquisition procedures for commercial products and services. While the FDA intends to proceed with a sole source award, firms may submit capability statements to Craig Wright or Shavone Jeter for review. The deadline for responses is May 29, 2026, at 5:00 pm ET. The government will utilize these responses to determine if a competitive procurement is possible, though the final decision remains within the sole discretion of the agency.
Generated by Lumen AI
Scoped analysis and attachments—go beyond the summary when you need detail from the solicitation package.