Loren Data's SAM Daily™

SAMDAILY.US - ISSUE OF SEPTEMBER 10, 2025 SAM #8689
SOLICITATION NOTICE

A -- Office of Clinical Pharmacology / Division of Applied Regulatory Science (DARS) � Critical DARS Laboratory Supplies

Notice Date

9/8/2025 12:38:01 PM
 

Notice Type

Solicitation
 

NAICS

541714 — Research and Development in Biotechnology (except Nanobiotechnology)
 

Contracting Office

FDA OFFICE OF ACQ GRANT SVCS Beltsville MD 20705 USA
 

ZIP Code

20705
 

Solicitation Number

FDA-CDER-25-130555
 

Response Due

9/12/2025 11:00:00 AM
 

Archive Date

09/15/2025
 

Point of Contact

Rodney D. Aytch, Phone: 2404027515
 

E-Mail Address

rodney.aytch@fda.hhs.gov
(rodney.aytch@fda.hhs.gov)
 

Small Business Set-Aside

NONE No Set aside used
 

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.
 

Web Link

SAM.gov Permalink
(https://sam.gov/opp/f2263abf750a489983a26a48b50ad839/view)
 

Place of Performance

Address: Silver Spring, MD 20993, USA

Zip Code: 20993

Country: USA
 

Record

SN07581445-F 20250910/250908230040 (samdaily.us)
 

Source

SAM.gov Link to This Notice
(may not be valid after Archive Date)

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