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基于高级质谱的生物制药产品构象完整性分析方法。

Advanced mass spectrometry-based methods for the analysis of conformational integrity of biopharmaceutical products.

机构信息

Department of Chemistry, University of Massachusetts-Amherst, Amherst, MA 01003, USA.

出版信息

Curr Pharm Biotechnol. 2011 Oct;12(10):1517-29. doi: 10.2174/138920111798357311.

Abstract

Mass spectrometry has already become an indispensable tool in the analytical armamentarium of the biopharmaceutical industry, although its current uses are limited to characterization of covalent structure of recombinant protein drugs. However, the scope of applications of mass spectrometry-based methods is beginning to expand to include characterization of the higher order structure and dynamics of biopharmaceutical products, a development which is catalyzed by the recent progress in mass spectrometry-based methods to study higher order protein structure. The two particularly promising methods that are likely to have the most significant and lasting impact in many areas of biopharmaceutical analysis, direct ESI MS and hydrogen/deuterium exchange, are focus of this article.

摘要

质谱已经成为生物制药行业分析工具中不可或缺的一部分,尽管其当前用途仅限于重组蛋白药物的共价结构的表征。然而,基于质谱的方法的应用范围开始扩大,包括生物制药产品的高级结构和动力学的表征,这一发展是由基于质谱的方法在研究高级蛋白质结构方面的最新进展所推动的。这两种特别有前途的方法,即直接 ESI-MS 和氢/氘交换,很可能在生物制药分析的许多领域产生最显著和持久的影响,是本文的重点。

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