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
- Safety testing to include endotoxin, mycoplasma, and bioburden
6
ISO7 cGMP Manufacturing Suites
Proven
Logistics & Warehousing Operations
Extensive
Flow Cytometry & Analytical Infrastructure
