Critical Reagents Issues & Solutions For Anti-Drug Antibody Assays
BIOANALYSIS(2021)
摘要
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.
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关键词
ADA, anti-drug antibody assays, critical reagents, life cycle management, performance characteristics
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