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在ADC分析的新前沿:染色学,电泳和质谱学的进步

Alain Beck¹, Valentina D'Atri², Olivier Verhoev^3,4

¹Institut de Recherche Pierre Fabre, CIPF, Toulouse, France.

The AAPS journal

|December 10, 2025

概括

先进的分析方法,包括液体色谱 (LC),毛细管电泳 (CE) 和质谱 (MS),对于表征抗体-药物合物 (ADC) 至关重要. 这些技术确保了下一代临床使用的ADC的质量和安全性.

科学领域:

生物结合化学生物结合化学
分析化学分析化学
制药科学制药科学

背景情况:

抗体-药物联合体 (ADCs) 代表了针对性癌症治疗的进步,可选择性地向瘤输送细胞毒性有效载荷.
与早期版本相比,开发新型ADC代目的是提高治疗疗效,减少患者的副作用.
强大的分析方法对于在ADC开发和制造过程中评估关键质量属性 (CQA) 是必不可少的.

研究的目的:

提供对ADC表征的尖端分析方法的全面审查.
专注于最近 (过去五年) 对ADC应用的LC,CE和MS技术的进展.
突出这些方法在理解ADC结构和生物转化中的作用.

主要方法:

液态染色学 (LC) 用于ADC种群的分离和分析.
毛细电泳 (CE) 用于ADC的高分辨率分离和表征.
质谱 (MS) 用于ADC变体和生物转化产品的详细结构阐明和识别.

主要成果:

在识别和量化由生物结合产生的多样化的ADC种群中,LC,CE和MS是至关重要的.
这些方法为ADC结构提供了深入的见解,并提供了体外和体外生物转化证据.
该审查强调为全面的ADC表征量身定制的分析策略.

结论:

像LC,CE和MS这样的先进分析技术对于强大的ADC表征是不可或缺的.
这些方法支持早期可开发性评估,并促进下一代ADC进入市场.
通过验证的分析方法确保结构完整性对于临床环境中的患者安全至关重要.

关键词:

在ADCs中,CQA的表征.生物转化产品的ADCs生物转化产品抗体-durg 结合体的特征表征.毛细管电泳可以通过毛细管电泳进行.液体色谱学液体色谱学液体色谱学质谱测量质量谱测量

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