The production of monoclonal antibody (mAb) therapeutics, a rapidly growing multi-billion-dollar enterprise in the biopharmaceutical industry, faces major challenges in achieving desired productivity and product quality consistently. These challenges, traditionally addressed by genetic engineering and media recipe development, are now being addressed with process systems engineering (PSE) techniques. In this perspective paper, we discuss how this alternative approach, comprising three components — process modeling, estimation, and control — is being used to address biomanufacturing challenges. We survey the state of current practice for each component, identify existing gaps, and highlight some advances needed to achieve routine implementation of fully automated systems for optimal bioprocess operations.

单克隆抗体 (mAb) 疗法的生产是生物制药行业中快速增长的价值数十亿美元的企业，在始终如一地实现所需的生产力和产品质量方面面临着重大挑战。这些传统上通过基因工程和培养基配方开发解决的挑战，现在正在通过过程系统工程 (PSE) 技术解决。在这篇观点论文中，我们讨论了这种替代方法如何由三个组成部分 —— 过程建模、估计和控制 —— 正被用于应对生物制造挑战。我们调查了每个组件的当前实践状态，确定了现有的差距，并强调了实现全自动系统的常规实施以优化生物过程操作所需的一些进步。