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用于生物治疗产品生产的生物反应器控制技术进展。

Advances in bioreactor control for production of biotherapeutic products.

作者信息

Nikita Saxena, Mishra Somesh, Gupta Keshari, Runkana Venkataramana, Gomes James, Rathore Anurag S

机构信息

Department of Chemical Engineering, DBT Centre of Excellence for Biopharmaceutical Technology, Indian Institute of Technology, Hauz Khas, Delhi, India.

TCS Research, Tata Consultancy Services Limited, Pune, India.

出版信息

Biotechnol Bioeng. 2023 May;120(5):1189-1214. doi: 10.1002/bit.28346. Epub 2023 Mar 1.

Abstract

Advanced control strategies are well established in chemical, pharmaceutical, and food processing industries. Over the past decade, the application of these strategies is being explored for control of bioreactors for manufacturing of biotherapeutics. Most of the industrial bioreactor control strategies apply classical control techniques, with the control system designed for the facility at hand. However, with the recent progress in sensors, machinery, and industrial internet of things, and advancements in deeper understanding of the biological processes, coupled with the requirement of flexible production, the need to develop a robust and advanced process control system that can ease process intensification has emerged. This has further fuelled the development of advanced monitoring approaches, modeling techniques, process analytical technologies, and soft sensors. It is seen that proper application of these concepts can significantly improve bioreactor process performance, productivity, and reproducibility. This review is on the recent advancements in bioreactor control and its related aspects along with the associated challenges. This study also offers an insight into the future prospects for development of control strategies that can be designed for industrial-scale production of biotherapeutic products.

摘要

先进的控制策略在化学、制药和食品加工行业已得到广泛应用。在过去十年中,人们一直在探索将这些策略应用于生物反应器的控制,以生产生物治疗药物。大多数工业生物反应器控制策略采用经典控制技术,控制系统是针对手头的设施设计的。然而,随着传感器、机械和工业物联网的最新进展,以及对生物过程更深入理解的进步,再加上灵活生产的需求,开发一种能够简化过程强化的强大而先进的过程控制系统的需求应运而生。这进一步推动了先进监测方法、建模技术、过程分析技术和软传感器的发展。可以看出,这些概念的正确应用可以显著提高生物反应器的过程性能、生产率和可重复性。本综述介绍了生物反应器控制及其相关方面的最新进展以及相关挑战。本研究还深入探讨了可用于生物治疗产品工业规模生产的控制策略的未来发展前景。

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