Mass spectrometry-based multi-attribute method in protein therapeutics product quality monitoring and quality control

作者：Feng Qiu Yang, Jennifer Y. Zhang, Alexander Buettner, Eva Vosika, Monica Sadek, Zhiqi Hao, Dietmar Reusch, Maximiliane Koenig, Wayman Chan, Anja Bathke, Hilary Pallat, Victor F. Lundin, Jochen Felix Kepert, Patrick Bulau, Galahad Deperalta, Christopher Yu, Richard Beardsley, Tura C. Camilli, Reed J. Harris, John T. Stults · 发表于：mAbs · 年份：2023 · DOI：10.1080/19420862.2023.2197668 · 被引用次数：56 · 研究领域：Protein purification and stability、Biosimilars and Bioanalytical Methods、Monoclonal and Polyclonal Antibodies Research

The multi-attribute method (MAM), a liquid chromatography-mass spectrometry (LC-MS)-based peptide mapping method, has gained increased interest and applications in the biopharmaceutical industry. MAM can, in one method, provide targeted quantitation of multiple site-specific product quality attributes, as well as new peak detection. In this review, we focus on the scientific and regulatory considerations of using MAM in product quality attribute monitoring and quality control (QC) of therapeutic proteins. We highlight MAM implementation challenges and solutions with several case studies, and provide our perspective on the opportunities to use MS in QC for applications other than standard peptide mapping-based MAM.