Finding biomarkers to predict clinical success by combining knowledge, subjects and data analysis

Summary

CHDR has a fully equipped cell culture laboratory, with flow hoods, CO2 incubators, a magnetic cell sorter, and experienced bioanalytical staff. This offers the possibility to setup up and apply cell-based systems for qualitative and quantitative characterization of innate and adaptive immune responses, and the effect of (pharmacological) interventions herein. CHDR has developed cell-based assays to investigate unintended drug effects (e.g. immune activation due to host cell proteins in biotherapeutics), and intended drug effects. The latter approach is mainly based on the induction of immune responses on primary human cells ex vivo, which can be applied as cell-based pharmacodynamic assay in a clinical pharmacology study. A battery of available tests includes, but is not limited to, TLR2-4-5 challenges, inflammasome challenges, endosomal TLR challenges, and T-cell mediated challenges by neoantigens or recall antigens. Importantly, CHDR is experienced with the development and application of cell-based assays tailored for the mechanism of action of the investigational compound. Such an assay can be developed independently by CHDR, or in close collaboration with the customer’s preclinical scientists