Immuno-safety

It is now widely accepted that the risk of immune-related adverse events in the clinic is something that should be assessed and de-risked during the drug development phase. Indeed, the FDA has issued updated draft guidance on Nonclinical Safety Evaluation of the Immunotoxic Potential of Drugs and Biologics (Feb 2020). It is increasingly recognized that evaluating the potential effects of drug candidates or biologics on the immune system earlier in the drug discovery process can enable the best candidate selection and reduce the risk of late-stage attrition.

Our Cytokine Release Assay can be used to profile candidates for effects on the immune system. Results can be compared with reference agents known to cause cytokine release syndrome (CRS) characterized by a broad in¬flammatory response and adverse reactions. The results obtained in the CRA assay can depend on several factors associated with the experimental design including incubation time, method of test substance exposure and the human whole blood samples selected. Our experts can help you select the best CRA assay design for your project and proposed mechanism of action. We provide easy-to-read and interpret results tables and our immunologists can guide you through what this means for your program.