The first WHO reference panel for Infliximab anti-drug antibodies: a step towards harmonizing therapeutic drug monitoring.

ABSTRACT: Immunogenicity testing for anti-drug antibodies (ADA) is mandatory for regulatory approval of a biotherapeutic and can, in some instances, continue post-licensure. Typical examples are TNF inhibitors where biotherapeutic and ADA levels are relevant in clinical decision-making for optimal patient therapy. However, challenges with non-comparability of results due to plethora of bioanalytical techniques and the lack of standardization has hindered ADA monitoring in clinical practice. Two human anti-infliximab monoclonal antibodies (A, B) with defined characteristics were therefore lyophilized and assessed for suitability as a reference panel for ADA assays in an international study. Binding assays included the simple ELISA and common electrochemiluminescence (ECL) to the rare antigen binding

SUBMITTER: Wadhwa M 

PROVIDER: S-EPMC11965635 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature