An accelerated approach to sensitive ADA assays

Monitoring of immune responses caused by biotherapeutic drug treatment is a regulatory requirement during preclinical development through to clinical trials. Optimization and validation of assays for anti-drug antibodies (ADA) is challenging, particularly when the drug itself is a human monoclonal antibody, due to the excess of human antibodies in serum and the relatively low immune response. Highly specific and sensitive detection antibodies are needed for robust pharmacokinetic (PK) and anti-drug antibody (ADA) assays. In this application note, Bio-Rad highlights a faster route to more sensitive assays for the monitoring of drug antibodies.