Analytical and Bioanalytical Chemistry

, Volume 403, Issue 3, pp 797–805

Multivariate statistics for the differentiation of erythropoietin preparations based on intact glycoforms determined by CE-MS

  • Angelina Taichrib
  • Markus Pioch
  • Christian Neusüß
Original Paper

DOI: 10.1007/s00216-012-5924-8

Cite this article as:
Taichrib, A., Pioch, M. & Neusüß, C. Anal Bioanal Chem (2012) 403: 797. doi:10.1007/s00216-012-5924-8

Abstract

Owing to the increasing number of erythropoietin biosimilars being approved, the comparison of different erythropoietin preparations in the pharmaceutical area is gaining in importance. Erythropoietin has a distinct natural heterogeneity arising from its glycosylation, which shows strong composition variations. This heterogeneity increases the complexity of the analysis of erythropoietin considerably, but may also be used to distinguish different preparations. Here, a method is presented for the differentiation of various erythropoietin preparations by capillary electrophoresis–mass spectrometry and the subsequent application of multivariate statistics. Relative peak areas of selected intact erythropoietin isoforms were used as variables in principal component analysis and hierarchical agglomerative clustering. Both of these strategies were suited for the clear differentiation of all erythropoietin preparations, including marketed products and preproduction preparations, which differ in the manufacturer, the production cell line, and the batch number. By this means, even closely related preparations were distinguished on the basis of the combined information on the antennarity, the sialoform, and the acetylation of the observed isoforms.

Keywords

Capillary electrophoresis–mass spectrometry Biosimilars Erythropoietin Principal component analysis Cluster analysis 

Copyright information

© Springer-Verlag 2012

Authors and Affiliations

  • Angelina Taichrib
    • 1
  • Markus Pioch
    • 1
  • Christian Neusüß
    • 1
  1. 1.Chemistry DepartmentAalen UniversityAalenGermany

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