Capillary electrophoresis sodium dodecyl sulfate (CE-SDS) is an analytical method to assess the purity of proteins, commonly applied to monoclonal antibodies (mAbs) in the biopharmaceutical industry. To address the need to standardize the CE-SDS method in the pharmaceutical industry and to enhance the confidence in method transfer between laboratories operating different commercial capillary electrophoresis (CE) instrument platforms, an interlaboratory CE-SDS method validation was organized involving 13 laboratories in 13 companies on four different types of commercial capillary electrophoresis instruments. In the validation, a commercial mAb therapeutic was used as the sample. The validation process followed the analytical guidelines set by the ICH guidelines (International Conference for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use). The method's precision, accuracy, linearity and range, and limit of quantitation (LOQ) were validated in the study. Variations of all the parameters validated in the study passed the pre-set criteria defined at the beginning of the study. The definition was based on previously published works and the intended application purpose of the CE-SDS method for mAbs. The study proved that the CE-SDS method fits its intended application purpose as a size impurity assay and size heterogeneity characterization assay for mAb therapeutic products. This study is the first time a CE-SDS method is validated by multiple laboratories using different commercial CE instrument platforms and on a commercial mAb therapeutic. Its results will enhance the confidence of the biopharmaceutical industry to develop CE-SDS methods and transfer CE-SDS methods between different laboratories.

中文翻译：

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用于分析 mAb 的毛细管电泳十二烷基硫酸钠 (CE-SDS) 方法的实验室间方法验证

毛细管电泳十二烷基硫酸钠 (CE-SDS) 是一种评估蛋白质纯度的分析方法，通常应用于生物制药行业的单克隆抗体 (mAb)。为满足制药行业对 CE-SDS 方法标准化的需求，并增强操作不同商业毛细管电泳 (CE) 仪器平台的实验室之间方法转移的信心，组织了一次跨实验室 CE-SDS 方法验证，涉及 13 个实验室的 13 个实验室公司提供四种不同类型的商用毛细管电泳仪器。在验证中，使用商业 mAb 治疗剂作为样品。验证过程遵循 ICH 指南（人用药品技术要求国际协调会议）制定的分析指南。该方法的精密度、准确度、线性和范围以及定量限 (LOQ) 在研究中得到验证。研究中验证的所有参数的变化都通过了研究开始时定义的预设标准。该定义基于先前发表的作品和用于 mAb 的 CE-SDS 方法的预期应用目的。该研究证明，CE-SDS 方法适合其作为 mAb 治疗产品的大小杂质测定和大小异质性表征测定的预期应用目的。这项研究是 CE-SDS 方法首次由多个实验室使用不同的商业 CE 仪器平台和商业 mAb 治疗剂进行验证。其结果将增强生物制药行业开发 CE-SDS 方法并在不同实验室之间转移 CE-SDS 方法的信心。