免疫捕获-液相色谱/质谱法抗药物抗体分析现状

Lin-Zhi Chen
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引用次数: 5

摘要

在药物开发过程中,密切监测抗药物抗体(ADA)的免疫原性评估。配体结合法是目前应用最广泛的ADA检测平台。最近,免疫捕获- lc /MS被开发用于ADA分析,包括同型和半定量。本文综述了免疫捕获- lc /MS ADA分析的相关文献,重点介绍了方法、应用和监管方面的研究。并提出了当前的思考和展望。
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Current Status of Anti-Drug Antibody Analysis Using Immunocapture-Liquid Chromatography/Mass Spectrometry
During drug development, anti-drug antibodies (ADA) is closely monitored for immunogenicity assessment. Ligand binding assay is currently the most widely used platform for ADA detection. Very recently, immunocapture-LC/MS was developed for ADA analysis including isotyping and semi-quantitation. This mini-review summarizes literatures pertaining to immunocapture-LC/MS ADA analysis with focus on methodology, applications and regulatory aspects. Current thinking and considerations as well as outlook are also presented.
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