Cell Therapy Analytical Development

Product Identification, Quality, Purity

  • Cell surface marker expression, viability
  • Comprehensive Flow Cytometric-based Characterization

Product Activity, Potency

  • Cytokine secretion via ELISA or Bead-based multi cytokine detection
  • Number of cells secreting cytokine of interest by ELISPOT
  • In vitro cell activation, cell cycle analysis
  • Cellular proliferation and expansion
  • Luminescence based Cytotoxicity assays
  • Gene expression, genotyping, copy number, microRNA

Product Stability, Safety

  • Stability Bioassay with Product Characterization
  • Sterility testing to include endotoxin, mycoplasma, and bioburden
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