Each lot of human cryopreserved hepatocytes undergoes extensive quality checks including:
- Morphology and cell health assessment
- Metabolic activity testing
- Genotyping analysis
- Review of donor demographics
- Application qualification
Morphology and cell health assessment (Figures 1 and 2)
- Post-thaw viability ≥80% and stability
- Cell shape and membrane integrity
- Nucleus and organelle size and shape
- Cytosolic clarity
- Relative absence of cell debris
- Cell–cell contacts and ≥80% confluency (plateable cells only)
- Reestablishment of bile canalicular networks (plateable cells only)
- Seeding density analysis
Donor demographics
- Gender
- Age
- Race
- BMI
- Serological data
- Medications
- History of smoking, alcohol, and drug abuse
Metabolic activity tests
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Application prequalification
Human cryopreserved hepatocytes are tested and qualified for one or more of the following:
- Suspension metabolism
- Plated metabolism (intrinsic clearance)
- CYP450 induction
- Transporter uptake (suspension and plated)
- Transporter uptake and efflux (plated)
![]() | ![]() | Figure 1. Comparison between poor and optimal human hepatocyte plated morphology. Hepatocytes isolated from separate donor tissues and cultured for several days produced divergent results - poor monolayer integrity was observed in lot A; whereas lot B exhibited optimal monolayer integrity. |
![]() | Figure 2. The relationship of seeding density to induction response. A recommended seeding density is supplied with each lot of GIBCO® human cryopreserved hepatocytes to ensure optimal induction response, as shown here with rifampicin. |
For Research Use Only. Not for use in diagnostic procedures.
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