Critical reagents issues & solutions for anti-drug antibody assays.

Anti-Drug Antibody assays (ADA) are developed and constructed with biological and chemical reagents. Capture and detector reagents as well as ADA standard are considered critical for the performance's characteristics of a bridging assay. Current literature well describes theoretical considerations to manage critical reagents (CR) life cycle management. Nevertheless, those recommendations must be completed by a pragmatic approach which have to be exemplified. This article intends to present and describe two study cases of bioanalytical challenge coming from the practical experience of dealing with ADA CR and offers a concrete explanation of how to solve issues. An appropriate management of ADA CR goes through availability anticipation, characterization and by a scientific understanding process of assay and reagents inconsistency.