# Office of Clinical Pharmacology / Division of Applied Regulatory Science (DARS) – Critical DARS Laboratory Supplies

Canonical: https://abierto.us/opportunities/fdacder25130555

- Solicitation number: FDA-CDER-25-130555
- Notice type: Solicitation
- Status: Closed. Deadline was September 12, 2025 at 2:00 PM EDT
- Department: Department of Health and Human Services
- Agency: Food and Drug Administration
- Contracting office: FDA Office of Acq Grant SVCS (75F401)
- NAICS: 541714 Research and Development in Biotechnology (except Nanobiotechnology)
- Product or service code: AJ12 General Science And Technology R&D Services; General Science And Technology; Applied Research
- Place of performance: Silver Spring, Maryland
- County: Montgomery County (FIPS 24031). https://abierto.us/counties/montgomery-county-md-24031
- City: Silver Spring. https://abierto.us/cities/silver-spring-md-2472450
- First posted: September 8, 2025
- Last posted: September 8, 2025
- SAM.gov: https://sam.gov/workspace/contract/opp/f2263abf750a489983a26a48b50ad839/view

## Description

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.

## Publications

- September 8, 2025: Solicitation, due September 12, 2025 at 2:00 PM EDT. Notice f2263abf750a489983a26a48b50ad839. https://sam.gov/workspace/contract/opp/f2263abf750a489983a26a48b50ad839/view

## Points of contact

- Rodney D. Aytch, rodney.aytch@fda.hhs.gov, 2404027515

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Source: SAM.gov Contract Opportunities bulk extract. Confirm deadlines on SAM.gov before responding. Cite https://abierto.us/opportunities/fdacder25130555.