BioAssay
The NCLi bioassay services team works with our customer to meet the quality and regulatory expectations for product characterization of cell based therapeutics.
- Product identity, purity, and potency
- Immunoassays: ELISA, Flow Cytometry
- Cell proliferation and differentiation
- Cell survival/cytotoxicity
- Product stability
- Other biological functions and parameters
- GCTP : Good Gene, Cellular, and Tissue-based Products Manufacturing Practice
- GMP : Good Manufacturing Practice
- CDMO : Contract Development and Manufacturing Organization