Back to Archived Journals » Biosimilars » Volume 6

Tools for the analysis and characterization of therapeutic protein species

Authors Fuh M, Steffen P, Schluter H

Received 30 November 2015

Accepted for publication 16 February 2016

Published 5 May 2016 Volume 2016:6 Pages 17—24


Checked for plagiarism Yes

Review by Single-blind

Peer reviewer comments 2

Editor who approved publication: Professor Shein-Chung Chow

Marceline Manka Fuh, Pascal Steffen, Hartmut Schlüter

Mass Spectrometric Proteomics, Institute for Clinical Chemistry and Laboratory Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany

Abstract: A continuously increasing number of therapeutic proteins are being released into the market, including biosimilars. In contrast to small organic drugs, therapeutic proteins require an extensive analysis of their exact chemical composition because of their complexity and proof of the absence of contaminants, such as host cell proteins and nucleic acids. Especially challenging is the detection of low abundant species of therapeutic proteins because these species are usually very similar to the target therapeutic protein. However, the detection of these species is very important for the safety of patients because a very small change of the exact chemical composition may cause serious side effects. In this review, we give a brief overview about the most important analytical approaches for characterizing therapeutic protein species and their contaminants and focus on the progress in this field during the past 3 years. Top-down mass spectrometry of intact therapeutic proteins in the future may solve many of the current problems in their analysis.

Keywords: therapeutic protein species, biosimilars, liquid chromatography, mass spectrometry, capillary electrophoresis

Creative Commons License This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at and incorporate the Creative Commons Attribution - Non Commercial (unported, v3.0) License. By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms.

Download Article [PDF]  View Full Text [HTML][Machine readable]