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.
