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.
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
- CYP1A2
- CYP2B6
- CYP2C8
- CYP2C9
- CYP2C19
- CYP2D6
- CYP2E1
- CYP3A
- FMO
- ECOD
- 7-HCG
- 7-HCS
- Others by request
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.
For Research Use Only. Not for use in diagnostic procedures.