Interlaboratory method validation of imaged capillary isoelectric focusing methodology for analysis of recombinant human erythropoietin.,Analytical Methods

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Interlaboratory method validation of imaged capillary isoelectric focusing methodology for analysis of recombinant human erythropoietin.
Analytical Methods ( IF 2.7 ) Pub Date : 2020-07-07 , DOI: 10.1039/d0ay00823k
Xiang Li ₁ , Xingchang Shi , Xi Qin , Lei Yu , Yong Zhou , Chunming Rao

Affiliation

Recombinant human erythropoietin (rhEPO) is one of the most important biopharmaceuticals worldwide, with global sales expected to reach US$11.9 billion in 2020. The charge heterogeneity of rhEPO must be monitored throughout the entire production process. Imaged capillary isoelectric focusing (icIEF) is a promising method for monitoring rhEPO charge heterogeneity, but it must be validated according to the ICH guideline (International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use). Here, a multi-laboratory joint method validation of the icIEF method for rhEPO analysis was performed according to the ICH Harmonized Tripartite Guideline on Analysis Procedure. This guideline includes specificity, precision, accuracy, linearity, range, LOQ and robustness, whereby precision is defined by the repeatability, intermediate precision and reproducibility.

中文翻译：

成像毛细管等电聚焦方法的实验室间方法验证，用于分析重组人促红细胞生成素。

重组人类促红细胞生成素（rhEPO）是全球最重要的生物制药之一，预计2020年全球销售额将达到119亿美元。rhEPO的电荷异质性必须在整个生产过程中进行监控。成像毛细管等电聚焦（icIEF）是监测rhEPO电荷异质性的一种有前途的方法，但必须根据ICH指南（国际人用药品技术要求协调委员会）进行验证。在这里，根据ICH Harmonized Tripartite Guideline on Analysis Procedure，对用于rhEPO分析的icIEF方法进行了多实验室联合方法验证。该指南包括特异性，精度，准确性，线性，范围，LOQ和鲁棒性，其中精度由可重复性定义，

更新日期：2020-08-06

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