Interlaboratory method validation of imaged capillary isoelectric focusing methodology for analysis of recombinant human erythropoietin. Issue 30 (17th July 2020)

• Record Type: Journal Article
• Authors: Li, Xiang; Shi, Xingchang; Qin, Xi; Yu, Lei; Zhou, Yong; Rao, Chunming
• Is Part Of: Analytical methods. Volume 12:Issue 30(2020)
• Page Start: 3836
• Page End: 3843
• Publication Date: 2020-07-17
• Subjects: Chemistry, Analytic -- Periodicals; Analytical biochemistry -- Periodicals; Chemical laboratories -- Standards -- Periodicals; 543.1905
• DOI: 10.1039/d0ay00823k
• Languages: English
• ISSNs: 1759-9660

Abstract

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. 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.