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系统氨基酸分析:治疗性蛋白质消光系数测定的进展

Systematically amino acid analysis: Advancements in extinction coefficient determination for therapeutic proteins.

作者信息

Xu Ya, Shao Zhenzhen, Zhang Lei, Cao Yanjing, Liu Zhuoyu, Zhang Zhongli

机构信息

Analytical Science Development, Henlius Biologics Co., Ltd, 5155 Guangfulin Road, Shanghai, 201616, China.

Analytical Science Development, Henlius Biologics Co., Ltd, 5155 Guangfulin Road, Shanghai, 201616, China.

出版信息

Anal Biochem. 2024 Jul;690:115508. doi: 10.1016/j.ab.2024.115508. Epub 2024 Mar 15.

DOI:10.1016/j.ab.2024.115508
PMID:38494101
Abstract

Biologicals developers often face challenges in accurately determining the extinction coefficient (EC) measurement. We have successfully improved the precision and robustness of the widely recognized amino acid analysis method for EC determination, through a stepwise optimization process. Extensive analyses based on 114 observations, covering eight proteins over three years were performed, with a maximum relative standard deviation of 1.5% among multiple analysts, and a maximum deviation of 2.8% from the theoretical EC across the eight given proteins examined.

摘要

生物制品研发人员在准确测定消光系数(EC)时常常面临挑战。我们通过逐步优化过程,成功提高了广泛认可的用于EC测定的氨基酸分析方法的精度和稳健性。基于114次观测进行了广泛分析,涵盖三年中的八种蛋白质,多位分析人员之间的最大相对标准偏差为1.5%,在所检测的八种给定蛋白质中,与理论EC的最大偏差为2.8%。

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Systematically amino acid analysis: Advancements in extinction coefficient determination for therapeutic proteins.系统氨基酸分析:治疗性蛋白质消光系数测定的进展
Anal Biochem. 2024 Jul;690:115508. doi: 10.1016/j.ab.2024.115508. Epub 2024 Mar 15.
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