Critical Reagents Issues & Solutions for Anti-Drug Antibody Assays.

Background: 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. Methodology: 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. Conclusion: An appropriate management of ADA CR goes through availability anticipation, characterization and by a scientific understanding process of assay and reagents inconsistency.