Cross-reactivity testing

Cross-reactivity studies are used to determine whether an antibody for medicinal or diagnostic use displays any 'unintentional' binding (other than to the target antigen) in a range of human tissues.

The testing is a regulatory requirement for the pre-clinical characterization of therapeutic and diagnostic antibodies. Cross-reactivity studies with human tissues or cells, where applicable, should always be conducted prior to Phase 1 clinical studies.