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.

糖基化是生物制药的关键质量属性，因为它是影响体内结构变异的主要来源这些产品的安全性和治疗功效。已知制造工艺条件会影响单糖的组成以及与治疗性蛋白质结合的复合碳水化合物的相对丰度。为了控制和优化生物药物的糖基化，已经开发了多种计算工具来描述这些过程/产品质量关系。这篇综述将提供一个摘要，重点介绍每种建模策略在应用于细胞糖工程或生物过程设计与控制中的优缺点。总之，提出了用于生物药物质量保证的潜在统一糖基化建模方法。