Advances in native high-performance liquid chromatography and intact mass spectrometry for the characterization of biopharmaceutical products

Abstract

The characterization of biotherapeutics represents a major analytical challenge. This review discusses the current state-of-the-art in analytical technologies to profile biopharma products under native conditions, i.e., the protein 3D conformation is maintained during liquid chromatographic analysis. Native liquid-chromatographic modes that are discussed include aqueous size-exclusion chromatography, hydrophobic interaction chromatography, and ion-exchange chromatography. Infusion conditions and the possibilities and limitations to hyphenate native liquid chromatography to mass spectrometry are discussed. Furthermore, the applicability of native liquid-chromatography methods and intact mass-spectrometry analysis for the characterization of monoclonal antibodies and antibody-drug conjugates is discussed.

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Authors/Creators:	Tassi, M De Vos, J Chatterjee, S Sobott, F https://orcid.org/0000-0001-9029-1865 Bones, J Eeltink, S
Copyright, Publisher and Additional Information:	(c) 2017 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim. This is the peer reviewed version of the following article: 'Tassi, M., De Vos, J., Chatterjee, S et al. Advances in native high-performance liquid chromatography and intact mass spectrometry for the characterization of biopharmaceutical products. Journal of Separation Science, 41 (1). pp. 125-144.' Published in final form at https://doi.org/10.1002/jssc.201700988. This article may be used for non-commercial purposes in accordance with the Wiley Terms and Conditions for Self-Archiving.
Keywords:	protein therapeutics, bioprocessing, native chromatography methods, intact and native mass spectrometry, ADC, mAb.
Dates:	Accepted: 29 September 2017 Published (online): 9 October 2017 Published: January 2018
Institution:	The University of Leeds
Academic Units:	The University of Leeds > Faculty of Biological Sciences (Leeds) > School of Molecular and Cellular Biology (Leeds)
Depositing User:	Symplectic Publications
Date Deposited:	01 Nov 2017 13:14
Last Modified:	09 Oct 2018 00:39
Status:	Published
Publisher:	Wiley
Identification Number:	https://doi.org/10.1002/jssc.201700988
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Advances in native high-performance liquid chromatography and intact mass spectrometry for the characterization of biopharmaceutical products

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