Computational tools for predicting and controlling the glycosylation of biopharmaceuticals

Glycosylation is a critical quality attribute of biopharmaceuticals because it is a major source of structural variability that influences the in vivo safety and therapeutic efficacy of these products. Manufacturing process conditions are known to influence the monosaccharide composition and relative abundance of the complex carbohydrates bound to therapeutic proteins. Multiple computational tools have been developed to describe these process/product quality relationships in order to control and optimise the glycosylation of biopharmaceuticals. This review will provide a summary highlighting the strengths and weaknesses of each modelling strategy in their application towards cellular glycoengineering or bioprocess design and control. To conclude, potential unified glycosylation modelling approaches for biopharmaceutical quality assurance are proposed