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Glycosylation of Therapeutic Proteins: A Critical Quality Attribute

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Mass Spectrometry of Glycoproteins

Part of the book series: Methods in Molecular Biology ((MIMB,volume 2271))

Abstract

Glycosylation is a common posttranslational modification of therapeutic proteins. The glycosylation pattern is dependent on many parameters such as the host cell line or the culture conditions. N- and O-linked glycans usually play a great role on the stability, safety, and efficacy of the drug. For this reason, glycosylation is considered as a critical quality attribute of therapeutic glycoproteins, and a thorough characterization should be performed, as well as a systematic control for each batch produced. This chapter gives a short presentation of the structure of glycans commonly found on recombinant therapeutic proteins, and their role on the properties of the drug, in terms of stability, pharmacokinetics, safety, and efficacy. Lastly, the use of mass spectrometry for the analysis of glycoproteins is briefly described.

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  1. Quality Assistance sa, Technoparc de Thudinie 2, Donstiennes, Belgium

    Arnaud Delobel

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  1. Arnaud Delobel
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Correspondence to Arnaud Delobel .

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  1. Quality Assistance S.A., Donstiennes, Belgium

    Arnaud Delobel

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Delobel, A. (2021). Glycosylation of Therapeutic Proteins: A Critical Quality Attribute. In: Delobel, A. (eds) Mass Spectrometry of Glycoproteins. Methods in Molecular Biology, vol 2271. Humana, New York, NY. https://doi.org/10.1007/978-1-0716-1241-5_1

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  • DOI: https://doi.org/10.1007/978-1-0716-1241-5_1

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  • Publisher Name: Humana, New York, NY

  • Print ISBN: 978-1-0716-1240-8

  • Online ISBN: 978-1-0716-1241-5

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