Wu Gang, Yu Chuanfei, Wang Wenbo, Wang Lan
Key Laboratory of the Ministry of Health for Research on Quality and Standardization of Biotech Products, National Institutes for Food and Drug Control, Dongcheng District, Beijing, P. R. China.
Electrophoresis. 2018 Aug;39(16):2091-2098. doi: 10.1002/elps.201800118.
CE is central to the analysis, process development and approval of therapeutic monoclonal antibodies (mAbs). Recently, imaged capillary isoelectric focusing (icIEF) has emerged as a powerful technique for quantitative protein charge heterogeneity monitoring and characterization, particularly for mAbs. However, icIEF has yet to be validated for therapeutically relevant mAbs adhering to the ICH guideline (International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use). Here, for the first time, icIEF technology was validated by 10 laboratories across 8 independent companies using a therapeutic mAb. The parameters of this method validation strictly follow the guideline of the ICH. This guideline includes specificity, precision, accuracy, linearity, range, LOQ and robustness. These results represent a significant step forward in standardizing the use of icIEF methods for the clinical approval of therapeutic mAbs.
毛细管电泳（CE）对于治疗性单克隆抗体（mAb）的分析、工艺开发和批准至关重要。最近，成像毛细管等电聚焦（icIEF）已成为一种强大的技术，用于定量蛋白质电荷异质性监测和表征，特别是对于单克隆抗体。然而，icIEF尚未针对符合国际人用药品注册技术协调会（ICH）指南的治疗相关单克隆抗体进行验证。在此，首次由8家独立公司的10个实验室使用一种治疗性单克隆抗体对icIEF技术进行了验证。该方法验证的参数严格遵循ICH指南。该指南包括特异性、精密度、准确度、线性、范围、定量限和稳健性。这些结果代表了在标准化icIEF方法用于治疗性单克隆抗体临床批准方面向前迈出的重要一步。
