Quantitative comparison of the N-glycosylation of therapeutic glycoproteins using the Glycosimilarity Index. A tutorial
2020
Szekrenyes, Akos | Szigeti, Marton | Dvorakova, Veronika | Jarvas, Gabor | Guttman, András
Glycosylation is considered as one of the crucial critical quality attributes of therapeutic glycoproteins and for their biosimilar counterparts. Carbohydrate moieties of such biopharmaceuticals should be closely monitored during all stages of development and manufacturing and studied accordingly during comparability or similarity exercises. In therapeutic glycoprotein production, the batch-to-batch alteration in glycosylation represents an excellent indicator of process robustness. Due to the complexity of the obtained glycoanalytical profile it is challenging to determine and describe the level of similarity between the N-glycosylation characteristics of two glycoprotein production lots or between the reference batch and its biosimilar versions. In this tutorial, we provide a step-by-step approach to calculate a numerical similarity value of N-glycosylation, referred to as Glycosimilarity Index that can be efficiently used to assess the conformity degree of any new N-glycosylation profile to a given target profile.
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