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开发和验证一种超灵敏的UPLC-MS/MS方法,用于定量Cynomolgus子血中的单甲基奥里斯丁E:用于药理动力学研究的应用

Bing Zhang¹, Lei Zhang¹, Yanfeng Liu¹

¹DMPK Department, Lab Testing Division, WuXi AppTec Co., Ltd, Nantong, Jiangsu, China.

|March 9, 2026

概括

一种新的生物分析方法准确地量化了子血中的单甲基奥里斯塔丁E (MMAE). 这种敏感的测定支持抗体-药物合物 (ADC) 药理学研究.

科学领域:

药理学药理学是指药理学的学科.
分析化学分析化学
生物技术是生物技术.

背景情况:

抗体-药物合物 (ADC) 是一种先进的癌症治疗药物.
单甲基奥里斯塔丁E (MMAE) 是一个常见的ADC有效载荷.
精确量化血中MMAE对于ADC的发展至关重要.

研究的目的:

开发和验证一种敏感的生物分析方法来量化MMAE.
为了支持非人类灵长类动物中ADC的药理动力学研究.

主要方法:

液体-液体提取 (LLE) 用于MMAE隔离.
液体染色学-并联质谱学 (LC-MS/MS) 用于量化.
根据监管生物分析指南进行验证.

主要成果:

该方法表现出极好的线性 (r ≥0.99) 从5到3000 pg/mL.
实现了高精度 (CV ≤15%) 和准确度 (83.98-112.75%).
方法验证符合严格的监管要求.

结论:

在Cynomolgus子血中建立了一种新的,验证的MMAE生物分析方法.
这种方法提供了高灵敏度,精度和效率.
验证的试验对于体内ADC的药理动力学概况和暴露-反应分析至关重要.

关键词:

抗体与药物的结合物.这是LC-MS/MS.生物分析是一种生物分析.方法验证方法的验证方法.单甲基奥里斯塔丁E 单甲基奥里斯塔丁E 药物动力学药物动力学

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