Automated mass spectrometry multi-attribute method analyses for process development and characterization of mAbs

Yvonne Ehwang Song, Hervé Dubois,Martin Hoffmann, Stephen D Eri,Yann Fromentin, Jan Wiesner,Anja Pfenninger,Séverine Clavier, Annette Pieper, Laurent Duhau, Udo Roth

Journal of Chromatography B（2021）

引用 32|浏览2

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摘要

•A Multi-Attribute Method (MAM) platform has been implemented in 3 Sanofi sites.•Platform with automated sample preparation, LCMS based MAM analysis and automatic data treatment.•Automated sample preparation and LCMS instrument inter-sites comparability done.•Application of the MAM to support bio development: cell line, cell culture and downstream process.

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关键词

Multi-attribute method,LC-MS,MAM,Automation,Process development,Critical quality attributes

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