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首页> 外文期刊>CHROMATOGRAPHY >Validation of Capillary Zone Electrophoretic Method for Evaluating Monoclonal Antibodies and Antibody-Drug Conjugates
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Validation of Capillary Zone Electrophoretic Method for Evaluating Monoclonal Antibodies and Antibody-Drug Conjugates

机译：毛细管区带电泳方法评估单克隆抗体和抗体-药物结合物的验证

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摘要

Based on capillary zone electrophoresis (CZE), we validated a method of confirming the identity and purity of the separated charge variants of monoclonal antibodies (mAbs) and antibody-drug conjugates (ADCs). The validation includes the evaluation of the specificity, linearity, quantitation limit, precision (repeatability and intermediate precision), accuracy, range, and robustness. The method is applicable to the majority of mAbs and ADCs (with pI from 7 to 9 and a drug to antibody ratio up to 8), requiring no modification to the method conditions. The proposed CZE method showed reproducible separation profiles, while cation exchange chromatography (CEX) showed low reproducibility and deficient separation profiles due to an undesirable interaction between the separation column and the low molecular weight drugs combined in the ADCs. Since CZE is able to minimize this undesirable interaction during the separation, it proved to be a useful separation methodology for evaluating charge variants of ADCs. The validation of CZE for assessing ADCs was successfully demonstrated for the first time, and show that CZE is suitable for the separation method for detecting the charge heterogeneity of ADCs.
机译：基于毛细管区带电泳（CZE），我们验证了一种确认单克隆抗体（mAbs）和抗体-药物偶联物（ADCs）分离电荷变异体的身份和纯度的方法。验证包括对特异性，线性，定量限，精度（重复性和中间精度），准确性，范围和鲁棒性的评估。该方法适用于大多数mAb和ADC（pI为7至9，药物与抗体之比最高为8），而无需修改方法条件。提出的CZE方法显示出可再现的分离曲线，而阳离子交换色谱（CEX）显示出低再现性和不足的分离曲线，这归因于分离柱和ADC中结合的低分子量药物之间的不良相互作用。由于CZE能够最小化分离过程中的这种不良相互作用，因此事实证明，CZE是评估ADC电荷变量的有用分离方法。首次成功地证明了用于评估ADC的CZE验证，并且表明CZE适合用于检测ADC电荷异质性的分离方法。

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