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生物制药行业中的生物反应器控制系统:批判性视角

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

作者信息

Mitra Sagnik, Murthy Ganti S

机构信息

Department of Biosciences and Biomedical Engineering, Indian Institute of Technology Indore, Indore, 453552 India.

出版信息

Syst Microbiol Biomanuf. 2022;2(1):91-112. doi: 10.1007/s43393-021-00048-6. Epub 2021 Aug 5.

Abstract

UNLABELLED

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.

摘要

未标注

工业规模的生物加工支撑着现代世界制药、营养保健品、食品和饮料加工行业的大部分生产。这些工艺的盈利能力越来越依赖于规模经济和范围经济,而这又严重依赖于产品产量、滴度和生产率。大多数工艺采用经典控制方法进行控制,占生物加工行业工业控制的90%以上。然而,随着生产工艺的进步,特别是在生物制药和营养保健品行业,对生物工艺(如转基因生物发酵)的监测和控制以及下游加工变得越来越复杂,经典控制系统技术和一些现代控制系统技术的不足也日益明显。因此,随着过程研究复杂性、非线性和数字化程度的不断提高,迫切需要更有效的先进过程控制,以实现更简便的过程强化和更高的产品产量(包括质量和数量)。在本综述中,对工艺和自动化的工业方面以及各种商业控制策略进行了广泛讨论,以深入了解工业发展的未来前景以及过程控制和自动化的可能新策略,特别关注生物制药行业。

补充信息

在线版本包含可在10.1007/s43393-021-00048-6获取的补充材料。

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