Multi-attribute method performance profile for quality control of monoclonal antibody therapeutics

Zhiqi Hao,Benjamin Moore, Chengfeng Ren,Monica Sadek,Frank Macchi, Lindsay Yang, Jack Harris, Laura Yee, Emily Liu, Vanessa Tran,Milady Ninonuevo,Yan Chen,Christopher Yu

Journal of Pharmaceutical and Biomedical Analysis（2021）

引用 21|浏览16

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摘要

•Analytical Target Profile for MAM application in monoclonal antibody therapeutics manufacturing.•An optimized MAM workflow.•The validation of its desired performance for robust quantitation.•The establishment of a comprehensive system suitability control.

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关键词

Multi-attribute method (MAM),Quality control (QC),Method validation,System suitability testing,Precision,Monoclonal antibody

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