Lonza � Cryopreserved Primary Human Hepatocytes (spheroid-qualified)

ry human hepatocytes from the manufacturer, Lonza, 8830 Biggs Ford Road, Walkersville, Maryland 21793-0127. The spheroid-qualified cryopreserved primary human hepatocytes are required to support Complement-ARIE research conducted by the National Center for Advancing Translational Sciences (NCATS) and NIEHS through the Mechanistic Toxicology Branch (MTB) within the Division of Translational Toxicology (DTT). The cells will be used to develop and evaluate human three-dimensional microphysiological systems for modeling toxicity-induced human liver injury and progression toward fibrotic damage. The requirement includes 60 vials of spheroid-qualified cryopreserved primary human hepatocytes from both male and female donors to support exploratory studies, optimization of culture conditions, and evaluation of potential sex-based differences in liver injury responses. Extensive market research was conducted to identify potential sources capable of meeting the Government�s scientific and technical requirements. Multiple potential vendors were considered and contacted; however, no other vendors were identified as capable of providing the required combination of spheroid-qualified cryopreserved primary human hepatocytes, male and female donor preparations, and appropriately characterized and re-qualified cell lots suitable for the Government�s established three-dimensional liver microtissue research approach. Lonza has specifically characterized and qualified the requested donor preparations for spheroid formation and has re-qualified eligible cell lots beyond their predetermined shelf life. These re-qualified lots provide the Government with the required cells at substantially reduced pricing while maintaining their suitability for the intended research. Due to the specialized nature of the Complement-ARIE research and the Government�s requirement for the specific combination of spheroid-qualified primary human hepatocytes, donor diversity, re-qualified cell lots, and compatibility with the established experimental approach, the Government intends to procure these supplies on a sole-source basis from Lonza. Lonza manufactures the required human hepatocyte preparations and, based on the market research conducted, is the only source identified that can satisfy the Government�s requirements. The Government has determined that these requirements are necessary to maintain consistency and comparability with the established research methodology, support reproducibility of experimental results, and avoid changes to the established cell source and experimental approach. The contractor shall provide 60 vials of spheroid-qualified cryopreserved primary human hepatocytes from male and female donors, as identified in the Government�s requirement. The cells shall be provided in liquid nitrogen storage and delivered to NIEHS in Rall Building 101, laboratories E144-146, located at 111 T.W. Alexander Drive, Research Triangle Park, North Carolina 27709. Acceptance will be demonstrated by successful delivery and successful formation of spheroids within the NIEHS laboratory. There is no travel for this purchase. This RFQ is being posted to the Governmentwide Point of Entry (GPE) in accordance with RFO FAR 5.201. This acquisition will be conducted in accordance with RFO FAR Part 12 � Acquisition of Commercial Products and Commercial Services, using the simplified procedures at RFO FAR 12.201-1. Required delivery date: September 25, 2026 Delivery Location: NIEHS, Rall Building 101, Laboratories E144-146, 111 T.W. Alexander Drive, Research Triangle Park, NC 27709 The applicable NAICS code is 325414 � Biological Product (except Diagnostic) Manufacturing. The applicable PSC is 6640 � Laboratory Equipment and Supplies. Please see the attached requirements document titled �75N98026Q01231 � Requirements Document� for additional information. 2.0 UNIQUE QUALIFICATIONS OF THE CONTRACTOR The proposed contractor, Lonza, is the manufacturer of the required spheroid-qualified cryopreserved primary human hepatocytes for the Complement-ARIE research conducted by NCATS and NIEHS. The required supplies involve 60 vials of cryopreserved primary human hepatocytes from both male and female donors that have been specifically qualified for spheroid formation and are intended to support human three-dimensional microphysiological systems for evaluating toxicity-induced liver injury and progression toward fibrotic damage. The Lonza human hepatocytes are specialized research materials that are required to support the Government�s established experimental approach for developing and evaluating three-dimensional liver microtissues. Lonza has specifically characterized and qualified the requested donor preparations for spheroid formation and has re-qualified eligible cell lots beyond their predetermined shelf life. Extensive market research was conducted, including discussions with multiple potential vendors, to identify sources capable of meeting the Government�s requirements. No other vendors were identified as capable of providing the complete combination of spheroid-qualified human hepatocytes, male and female donor preparations, re-qualified cell lots, and associated technical characterization required for the research. Use of an alternate source could require modifications to the established experimental approach and culture conditions and could affect the comparability and reproducibility of results across the research program. Accordingly, Lonza is the only identified responsible source capable of providing the complete combination of human hepatocyte preparations required to meet the Government�s scientific and technical requirements while maintaining the established experimental approach. BASIS FOR AWARD The Government intends to issue a firm-fixed-price purchase order to Lonza. However, all timely quotations received will be considered. To be considered for award, a quotation must demonstrate that the products offered satisfy all the Government's scientific and technical requirements identified in this RFQ and the attached requirements document. Award will be made to the responsible organization whose quotation satisfies the Government's requirements and whose price is determined fair and reasonable. RESPONSE INSTRUCTIONS This is a Request for Quotation (RFQ) for commercial products issued in accordance with the simplified procedures of RFO FAR Part 12. The Government intends to award a purchase order on a sole-source basis to Lonza based on the Government's determination that Lonza is the only source identified as capable of satisfying the Government's requirements. However, all responsible sources may submit a quotation that demonstrates their ability to satisfy the complete requirements identified in this RFQ and the attached requirements document. All timely quotations will be considered by the Government. The response and any other information furnished must be in writing and must contain material in sufficient detail to allow the Office of Acquisition and Logistics Management (OALM) to determine whether the respondent can fulfill the requirement. Quotations shall identify the products being offered, manufacturer and part numbers, quantities, unit and total prices, delivery schedule, donor characteristics, cell lot information, spheroid qualification and characterization information, re-qualification stat