Cell-Based Assay
The potential of biomarkers to facilitate the development of effective and safe drugs has been well recognized as an integral part of all phases of drug development. As molecular and cell biology science advances, cell-based technologies have become a critical part of biomarker discovery, development and target validation.
At QPS, our scientific team has a wide range of molecular and cell biology experiences, working with both the established cell lines and primary cultures to meet sponsor’s study needs. Since 2002, QPS has supported more than 40 cell-based studies for numerous sponsors. Our expertise ranges from cell banking, cell proliferation assays, on-site cell stimulation followed by cytokine induction analysis and various target specific functional assays. Although cell-based assays do not have current standardized industry guidance, we have developed and validated cell-based assays in GLP environment to assess neutralizing antibody activity in human serum samples in support of the clinical investigation of anti-drug antibodies (ADA) on drug efficacy and safety.
QPS experienced cell-based assays include:
- Endotoxin Stimulation (Cytokine Production)
- Compound Toxicity on Monocytes (Cytokine Induction)
- Uptake Study (33P) Using Primary Cells
- Toxin Neutralizing Assay (Cell Proliferation)
- Neutralizing Antibody (NAb) Assay (Cell Viability)
- Custom Functional Assay
Our cell culture facility is well equipped with BSL2 biosafety hoods, CO2 incubators, automated cell counter, microscopes with cameras and imaging capability, as well as liquid nitrogen tanks for cell banking.