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统一和多功能多重平台,用于加快方法开发和治疗的综合性表征

Alexandre Goyon¹, Shirley Wang¹, Kate Hofmann¹

¹Synthetic Molecule Pharmaceutical Sciences, Genentech, 1 DNA Way, South San Francisco, California 94080, United States.

Analytical chemistry

|August 17, 2024

概括

一个新的多重平台通过自动化尺寸排除色谱 (SEC),RPLC-RPLC和HILIC-CAD来加速类药物表征. 这使得能够同时确定多个质量属性,以改善药物开发.

科学领域:

分析化学分析化学
制药科学制药科学

背景情况:

类药物开发需要敏捷和全面的分析方法来快速表征.
目前的方法可能耗时,可能不同时涵盖所有关键质量属性.

研究的目的:

开发一个统一的,多功能多重平台,用于加快方法开发和同时确定多个质量属性的常规测定.
评估平台在各种治疗性构造上的性能,包括宏环和二硫化物受约束.

主要方法:

集成自动化尺寸排除色谱 (SEC),反相液体色谱-反相液体色谱 (RPLC-RPLC) 和水友交互液体色谱-充电气溶检测 (HILIC-CAD).
系统地研究移动相对杂质配置的作用,使用不同的SEC列.
使用RPLC-RPLC进行全面的杂质分析,具有多种列和移动相.
开发HILIC-CAD方法用于三酸 (TFA) 的量化.

主要成果:

一个原型的MaxPeak Premier SEC柱能够分离杂质 (>2.0%面积),性能优于标准的BEH二醇柱.
RPLC-RPLC促进了加快方法开发和在12个条件中进行全面的杂质分析.
成功开发了一种HILIC-CAD方法,用于产品中的TFA量化.

结论:

开发的多重平台显著加快了对类药物候选物的分析方法开发.
该平台可以同时,常规确定多个质量属性,提高表征效率.
这种方法通过提供强大的杂质分析和量化来支持复杂疗法的开发.

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