PDF(Pubmed)
Abstract：
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.
摘要：
多属性方法(MAM)，基于液相色谱-质谱（LC-MS）的肽作图方法，在生物制药行业获得了越来越多的兴趣和应用。MAM可以,在一种方法中，提供多个特定地点的产品质量属性的有针对性的定量，以及新的峰值检测。在这次审查中,我们专注于在治疗性蛋白质的产品质量属性监测和质量控制（QC）中使用MAM的科学和监管考虑。我们通过几个案例研究重点介绍了MAM实施挑战和解决方案，并提供了我们对在QC中使用MS的机会的看法，这些应用除了基于标准肽作图的MAM之外。
