Issue 30, 2020

Interlaboratory method validation of imaged capillary isoelectric focusing methodology for analysis of recombinant human erythropoietin

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.

Graphical abstract: Interlaboratory method validation of imaged capillary isoelectric focusing methodology for analysis of recombinant human erythropoietin

Supplementary files

Article information

Article type
Paper
Submitted
22 Apr 2020
Accepted
01 Jul 2020
First published
07 Jul 2020

Anal. Methods, 2020,12, 3836-3843

Interlaboratory method validation of imaged capillary isoelectric focusing methodology for analysis of recombinant human erythropoietin

X. Li, X. Shi, X. Qin, L. Yu, Y. Zhou and C. Rao, Anal. Methods, 2020, 12, 3836 DOI: 10.1039/D0AY00823K

To request permission to reproduce material from this article, please go to the Copyright Clearance Center request page.

If you are an author contributing to an RSC publication, you do not need to request permission provided correct acknowledgement is given.

If you are the author of this article, you do not need to request permission to reproduce figures and diagrams provided correct acknowledgement is given. If you want to reproduce the whole article in a third-party publication (excluding your thesis/dissertation for which permission is not required) please go to the Copyright Clearance Center request page.

Read more about how to correctly acknowledge RSC content.

Social activity

Spotlight

Advertisements