Lonza – Cryopreserved Primary Human Hepatocytes (spheroid-qualified)

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 microtissu