Office of Clinical Pharmacology / Division of Applied Regulatory Science (DARS) – Critical DARS Laboratory Supplies
Closed Solicitation Posted
- Solicitation number
- FDA-CDER-25-130555
- Agency
-
FDA Office of Acquisition and Grant Services
Food and Drug Administration, Department of Health and Human Services
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 541714 Research and Development in Biotechnology (except Nanobiotechnology)
- PSC
- AJ12 General Science And Technology R&D Services; General Science And Technology; Applied Research
- Place of performance
- Silver Spring, Maryland 20993, United States
- Points of contact
Notice details come from SAM.gov. Updated .
About this opportunity
The Food and Drug Administration's Center for Drug Evaluation and Research is seeking cryopreserved human hepatocytes for a research project examining the effect of female sex hormones on in vitro drug metabolism and transport. The Division of Applied Regulatory Science requires hepatocytes from six female donors across two age groups (20-35 years and 50-70 years), with specific qualifications for metabolism enzymes (CYP1A2, CYP2B6, CYP2C9, CYP2C19, CYP2D6, CYP3A4) and transporters (OATP1B1, OATP1B3). Each vial must contain a minimum of 5 million viable hepatocytes that can be plated in 12-well plates and remain functional for 4-5 days post-plating. The procurement will be evaluated using Lowest Priced Technically Acceptable (LPTA) criteria, meaning the technically compliant proposal with the lowest price will be selected. Proposals are due by 3:00 p.m. Eastern Time on September 12, 2025, with protocols required to be submitted to the project officer Donna Volpe prior to shipping.
This solicitation does not utilize any set-aside designations and is open to all qualified contractors. No incumbent contractors are identified in the documentation. The contract will procure up to 72 total vials of cryopreserved human hepatocytes, with 36 vials being transporter-certified and 36 vials being metabolism-certified from 6 or 12 different female donors depending on qualification specifications. The contract will be structured as a firm fixed-price purchase order with a one-year performance period. Performance will take place at the FDA facility in Silver Spring, Maryland, with delivery required to that location. The solicitation falls under NAICS code 541714 for Research and Development in Biotechnology services.
Notice text
The Division of Applied Regulatory Science (DARS) OCP/OTS/CDER is conducting a research project to examine the effect of female sex hormones on in vitro drug metabolism and transport. As part of this process, DARS needs to acquire cryopreserved human hepatocytes from multiple female donors of different age groups to conduct this research.
For successful metabolism and transporter function to occur the following quality characteristics are essential for the study:
- Single female donor lots
- Three donors aged 20-35 years and three donors aged 50-70 years
- A minimum of 5 × 106 (5 million) viable hepatocytes per vial
- Must be platable in 12-well plates and remain functional for 4-5 days post-plating
- Metabolism- and/or transporter-qualified
- Metabolism qualifications: CYP1A2, CYP2B6, CYP2C9, CYP2C19, CYP2D6, CYP3A4
- Transporter qualifications: OATP1B1, OATP1B3 (OAT2 and OCT1 if available)
The supplier is to provide protocol(s) for the thawing, plating and culturing the hepatocytes. This is to include the media composition and source for all these stages for the hepatocytes. The protocol(s) are to be sent to Donna Volpe (donna.volpe@fda.hhs.gov) as .pdf files prior to shipping the hepatocyte vials.
The supplier will provide up to a total of 72 vials of cryopreserved human hepatocytes from 6 or 12 different female donors, depending on how the hepatocytes are qualified/certified for metabolism and transporter activity.
Files
| File | Type | Posted |
|---|---|---|
| Attachment 2 - HHS Class Deviation.pdf | ||
| Attachment 1 FAR Class Deviation.pdf | ||
| RFQ - FDA-CDER-25-130555.pdf |
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