- Country: USA
- Summary: Office of Clinical Pharmacology / Division of Applied Regulatory Science (DARS) - Critical DARS Laboratory Supplies
- UST Ref No: 125931952
- Deadline: 12 Sep 2025
- Financier: Self Financed
- Purchaser Ownership: Government
- Tender Value: Refer Document
- Notice Type: Tender
- Document Ref. No.: FDA-CDER-25-130555
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- Description:
- 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. - Documents:
Attachment-2-HHS-Class-Deviation.pdf
Attachment-1-FAR-Class-Deviation.pdf
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CLICK HERE TO LOGINOffice of Clinical Pharmacology / Division of Applied Regulatory Science (DARS) - Critical DARS Laboratory Supplies - USA Tender
The HEALTH AND HUMAN SERVICES, DEPARTMENT OF | FOOD AND DRUG ADMINISTRATION, a Government sector organization in USA, has announced a new tender for Office of Clinical Pharmacology / Division of Applied Regulatory Science (DARS) - Critical DARS Laboratory Supplies. This tender is published on USARFP under UST Ref No: 125931952 and is categorized as a Tender. Interested and eligible suppliers are invited to participate by reviewing the tender documents and submitting their bids before the deadline on 2025-09-12.
The estimated tender value is Refer Document, and full details, including technical specifications and submission requirements, are provided in the official tender documents. Ensure all submissions meet the criteria outlined to be considered for evaluation.
