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通过核酶P1消化结合LCMS分析确定酸寡核酸的立体化学可比性

Zifan Li¹, Fei Tong¹, Li Xiao¹

¹Pharmaceutical Operations & Technology, Biogen, 225 Binney Street, Cambridge, MA 02142, USA. zifan.li@biogen.com.

|September 27, 2023

概括

制造治疗性酸寡核酸需要立体化学一致性. 一个使用核酶P1消化和LCMS分析的新协议可以检测单酸链接中的立体化学变化,确保药物的质量.

科学领域:

化学制造业化学制造业制造业
分析化学分析化学
生物制药学分析

背景情况:

确保治疗性酸寡核酸的制造一致性至关重要.
目前用于评估这些疗法中的立体化学的分析方法有限.

研究的目的:

开发一种用于检测酸酸链接中的立体化学变化的新方案.
建立一种方法,以确保生产的一致性,在核酸治疗药物.

主要方法:

使用核酶P1消化寡核酸.
随后的液态染色学质谱学 (LCMS) 分析得到的碎片.
检测单一酸链接中的立体化学变化.

主要成果:

一个新的协议被成功开发和报告.
该方法可以检测单个酸酸链接中的立体化学变化.
该协议是有效的评估立体化学可比性.

结论:

开发的方法对于建立立体化学可比性非常有价值.
该协议确保了寡核酸治疗药物的制造一致性.
这些发现支持对基于寡核酸的药物的质量控制.

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