WHO/BS/2022.2430: Proposed 1st WHO International Reference Panel for Infliximab anti-drug antibodies

Overview

A panel of two human monoclonal antibodies against human infliximab with defined characteristics (varied isotypes, different binding characteristics but both neutralising) were formulated, lyophilized and assessed for their suitability as reference standard(s) in infliximab antibody assays in an international study. The multi-centre collaborative study involved seventeen different laboratories using different assay platforms and a diverse range of infliximab anti-drug antibody (ADA) binding and neutralisation assays. The study which included testing of several anti-infliximab monoclonal antibody preparations and serum samples clearly indicated the utility and suitability of the lyophilized antibody preparations, A coded 19/234 and B coded 19/232 as a WHO international reference panel for infliximab ADA assays.