工业规模的生物加工是大部分药品生产的基础,营养食品,食物,和现代世界的饮料加工业。这些过程的盈利能力越来越多地利用了规模经济和范围经济,这些经济严重依赖于产品产量,滴度,和生产力。大多数过程使用经典控制方法进行控制,并且代表了生物加工行业中使用的90%以上的工业控制。然而,随着生产工艺的进步,特别是在生物制药和营养食品行业,监测和控制生物过程,如转基因生物的发酵,和下游处理变得越来越复杂,传统和一些现代控制系统技术的不足之处变得越来越明显。因此,随着研究复杂性的增加,非线性,以及过程中的数字化,迫切需要更有效的先进过程控制,和更容易的过程强化和产品产量(无论是质量和数量)可以实现。在这次审查中,工业方面的过程和自动化以及各种商业控制策略进行了广泛的讨论,以深入了解工业发展的未来前景以及可能的过程控制和自动化新策略,特别关注生物制药行业。
■在线版本包含10.1007/s43393-021-00048-6提供的补充材料。
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.
UNASSIGNED: The online version contains supplementary material available at 10.1007/s43393-021-00048-6.