Lonza – Cryopreserved Primary Human Hepatocytes (spheroid-qualified)

O que a entidade adjudicante procura

1.0 DESCRIPTION This is a Combined Synopsis/Solicitation for commercial products 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. This notice serves as the solicitation. Quotations are being requested, and a separate written solicitation will not be issued. The Department of Health and Human Services (HHS), National Institutes of Health (NIH), National Institute of Environmental Health Sciences (NIEHS), intends to procure, on a sole source basis, spheroid-qualified cryopreserved primary 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…

Idioma deste anúncio: English. O título e a descrição são apresentados tal como a entidade adjudicante os publicou.