Monoclonal antibodies (mAbs) are the highest-selling class of biopharmaceuticals due to their capabilities in treating severe illnesses. Thus, strategies to optimise their manufacture have been at the centre of recent academic and industrial research. Mechanistic and statistical modelling approaches are considered useful tools in that quest, not only because they can be employed for online process monitoring but also due to their abilities to offer useful insight into how the underlying micro and macro-scale phenomena of upstream bioprocesses impact the yield and quality of biopharmaceuticals. This manuscript provides an overview of the mechanistic and statistical models of upstream mAb bioprocesses that have been published over the past five years and discusses their advantages and drawbacks. We conclude with an outline of synergistic, hybrid modelling strategies, which are emerging as key tools in the era of Biopharma 4.0.

单克隆抗体 (mAb) 是最畅销的一类生物药物，因为它们具有治疗严重疾病的能力。因此，优化其制造的策略已成为近期学术和工业研究的中心。机械和统计建模方法被认为是该任务中的有用工具，不仅因为它们可用于在线过程监控，而且还因为它们能够提供有用的洞察力，了解上游生物过程的潜在微观和宏观尺度现象如何影响产量和生物制药的质量。这份手稿概述了过去五年中发表的上游 mAb 生物过程的机械和统计模型，并讨论了它们的优点和缺点。我们以协同作用的概述结束，