O'Flaherty, Roisin, Trbojevic-Akmacic, Irena, Greville, Gordon, Rudd, Pauline M. and Lauc, Gordan (2018) The sweet spot for biologics: recent advances in characterization of biotherapeutic glycoproteins. Expert Review of Proteomics, 15 (1). pp. 13-29. ISSN 1478-9450
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Abstract
Introduction: Glycosylation is recognized as a Critical Quality Attribute for therapeutic glycoproteins
such as monoclonal antibodies, fusion proteins and therapeutic replacement enzymes. Hence, efficient
and quantitative glycan analysis techniques have been increasingly important for their discovery,
development and quality control. The aim of this review is to highlight relevant and recent advances
in analytical technologies for characterization of biotherapeutic glycoproteins.
Areas covered: The review gives an overview of the glycosylation trends of biotherapeutics approved
in 2016 and 2017 by FDA. It describes current and novel analytical technologies for characterization of
therapeutic glycoproteins and is explored in the context of released glycan, glycopeptide or intact
glycoprotein analysis. Ultra performance liquid chromatography, mass spectrometry and capillary
electrophoresis technologies are explored in this context.
Expert commentary: There is a need for the biopharmaceutical industry to incorporate novel state of
the art analytical technologies into existing and new therapeutic glycoprotein workflows for safer and
more efficient biotherapeutics and for the improvement of future biotherapeutic design. Additionally, at
present, there is no ‘gold-standard’ approach to address all the regulatory requirements and as such
this will involve the use of orthogonal glycoanalytical technologies with a view to gain diagnostic
information about the therapeutic glycoprotein.
Item Type: | Article |
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Keywords: | Capillary electrophoresis; critical quality attribute; electrospray ionization-mass spectrometry; fusion protein; glycopeptide; glycoprotein; immunoglobulin; monoclonal antibody; ultra performance liquid chromatography; ms/ms; |
Academic Unit: | Faculty of Science and Engineering > Chemistry |
Item ID: | 15036 |
Identification Number: | 10.1080/14789450.2018.1404907 |
Depositing User: | Roisin O'Flaherty |
Date Deposited: | 16 Nov 2021 16:42 |
Journal or Publication Title: | Expert Review of Proteomics |
Publisher: | Taylor and Francis |
Refereed: | Yes |
Related URLs: | |
URI: | https://mu.eprints-hosting.org/id/eprint/15036 |
Use Licence: | This item is available under a Creative Commons Attribution Non Commercial Share Alike Licence (CC BY-NC-SA). Details of this licence are available here |
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