Investigation of common issues in cross-reactivity test of monoclonal antibody drugs

Cross-reactivity test of monoclonal antibody is an important part in preclinical safety evaluation of drugs.It supports the toxicity monitoring in the clinical application of drugs by screening assay for off-target binding.With the change and development of monoclonal antibody drugs from murine monoclonal antibody to humanized monoclonal antibody,some issues have arisen in cross-reactivity test of monoclonal antibody drugs,including specimens,tissues,experimental design,concentration of antibody and analysis of results and so on.In this paper,we discuss those problems based on the experience and practical work in monoclonal antibody cross-reactivity test in recent years,hoping to promote and facilitate our technology in preclinical safety evaluation of drugs.