Cell Therapy Analytical Development
Extensive experience and infrastructure to support analytical development for cell therapy
Analytical Development for Cell Therapy
Unmatched Expertise and State-of-the-Art Facilities
At KBI Biopharma, we are at the forefront of the rapidly-evolving field of cell therapy, providing a wide range of cutting-edge services to support the development and commercialization of next-generation cell-based treatments.
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
- Safety testing to include endotoxin, mycoplasma, and bioburden
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