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    The sweet spot for biologics: recent advances in characterization of biotherapeutic glycoproteins


    O'Flaherty, Roisin and Trbojevic-Akmacic, Irena and Greville, Gordon and 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
    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: https://doi.org/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
    URI:

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