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

Analytical Methods : Advancing Methods and Applications
Xiang LiChunming Rao

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.

References

Nov 1, 1985·Proceedings of the National Academy of Sciences of the United States of America·F K LinZ Stabinsky
May 1, 1984·Proceedings of the National Academy of Sciences of the United States of America·S Lee-Huang
Jul 15, 1994·Journal of Chromatography. B, Biomedical Applications·J Wu, J Pawliszyn
Jan 24, 2006·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Matthew E HardeeMark W Dewhirst
Jul 11, 2006·Advanced Drug Delivery Reviews·Steven Kozlowski, Patrick Swann
Jan 9, 2007·Alimentary Pharmacology & Therapeutics·S Kulnigg, C Gasche
Sep 11, 2008·Journal of Pharmaceutical Sciences·Sungae S ParkBruce A Kerwin
Aug 9, 2016·Analytica Chimica Acta·Sille Štěpánová, Václav Kašička
May 5, 2017·The Analyst·Mohamed DawodRobert T Kennedy

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