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)
    Comparison between poor and optimal human hepatocyte plated morphology
    Comparison between poor and optimal human hepatocyte plated morphology

    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.

    The relationship of seeding density to induction response

    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.

    仅供科研使用，不可用于诊断目的。

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