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Updated: Dec 14, 2025

Highly Sensitive and Quantitative Detection of Proteins and Their Isoforms by Capillary Isoelectric Focusing Method
Published on: September 19, 2018
Interlaboratory method validation of imaged capillary isoelectric focusing methodology for analysis of recombinant
Xiang Li1, Xingchang Shi, Xi Qin
1Key Laboratory of the Ministry of Health for Research on Quality and Standardization of Biotech Products, National Institutes for Food and Drug Control, No. 2, Tiantan Xili, Dongcheng District, Beijing, 100050, China. lix@nifdc.org.cn shixc@nifdc.org.cn raocm@nifdc.org.cn.
Abstract:
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.
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