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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

DOI https://doi.org/10.2147/BS.S68103

Checked for plagiarism Yes

Review by Single-blind

Peer reviewers approved by Dr Lucy Goodman

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

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