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