Bioreactor control systems in the biopharmaceutical industry: a critical perspective.

Sagnik Mitra, Ganti S Murthy
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Abstract

Industrial-scale bioprocessing underpins much of the production of pharmaceuticals, nutraceuticals, food, and beverage processing industries of the modern world. The profitability of these processes increasingly leverages the economies of scale and scope that are critically dependent on the product yields, titers, and productivity. Most of the processes are controlled using classical control approaches and represent over 90% of the industrial controls used in bioprocessing industries. However, with the advances in the production processes, especially in the biopharmaceutical and nutraceutical industries, monitoring and control of bioprocesses such as fermentations with GMO organisms, and downstream processing has become increasingly complex and the inadequacies of the classical and some of the modern control systems techniques is becoming apparent. Therefore, with increasing research complexity, nonlinearity, and digitization in process, there has been a critical need for advanced process control that is more effective, and easier process intensification and product yield (both by quality and quantity) can be achieved. In this review, industrial aspects of a process and automation along with various commercial control strategies have been extensively discussed to give an insight into the future prospects of industrial development and possible new strategies for process control and automation with a special focus on the biopharmaceutical industry.

Supplementary information: The online version contains supplementary material available at 10.1007/s43393-021-00048-6.

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生物制药工业中的生物反应器控制系统:一个重要的视角。
工业规模的生物加工是现代制药、营养保健品、食品和饮料加工业生产的基础。这些工艺的盈利能力越来越多地依赖于产品产量、滴定度和生产率的规模经济和范围经济。大多数工艺都采用传统控制方法进行控制,占生物加工行业所用工业控制方法的 90% 以上。然而,随着生产工艺的发展,特别是生物制药和营养保健品行业的发展,对转基因生物发酵和下游加工等生物工艺的监测和控制变得越来越复杂,传统和一些现代控制系统技术的不足之处也变得越来越明显。因此,随着研究复杂性、非线性和过程数字化的增加,迫切需要更有效、更容易实现过程强化和产品产量(质量和数量)的先进过程控制。本综述广泛讨论了流程和自动化的工业方面以及各种商业控制策略,以便深入了解工业发展的未来前景以及流程控制和自动化的可能新策略,并特别关注生物制药行业:在线版本包含补充材料,可在 10.1007/s43393-021-00048-6 上查阅。
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