Perspectives on the flexibility analysis for continuous pharmaceutical manufacturing processes

doi:10.1016/j.cjche.2021.12.005

中国化学工程学报 ›› 2022, Vol. 41 ›› Issue (1): 29-41.DOI: 10.1016/j.cjche.2021.12.005

Perspectives on the flexibility analysis for continuous pharmaceutical manufacturing processes

Wenhui Yang¹, Wuxi Qian², Zhihong Yuan¹, Bingzhen Chen²

1 State Key Laboratory of Chemical Engineering, Department of Chemical Engineering, Tsinghua University, Beijing 100084, China;
2 Department of Chemical Engineering, Tsinghua University, Beijing 100084, China

收稿日期:2021-07-04 修回日期:2021-12-08 出版日期:2022-01-28 发布日期:2022-02-25
通讯作者: Zhihong Yuan,E-mail address:zhihongyuan@mail.tsinghua.edu.cn
基金资助:
The authors gratefully acknowledge the financial support from the Ministry of Science and Technology of China (2018AAA0101602).

Perspectives on the flexibility analysis for continuous pharmaceutical manufacturing processes

Wenhui Yang¹, Wuxi Qian², Zhihong Yuan¹, Bingzhen Chen²

1 State Key Laboratory of Chemical Engineering, Department of Chemical Engineering, Tsinghua University, Beijing 100084, China;
2 Department of Chemical Engineering, Tsinghua University, Beijing 100084, China

Received:2021-07-04 Revised:2021-12-08 Online:2022-01-28 Published:2022-02-25
Contact: Zhihong Yuan,E-mail address:zhihongyuan@mail.tsinghua.edu.cn
Supported by:
The authors gratefully acknowledge the financial support from the Ministry of Science and Technology of China (2018AAA0101602).

摘要/Abstract

摘要： Pharmaceutical continuous manufacturing, especially under the context of COVID-19 pandemic, is regarded as an emerging technology that can guarantee the adequate quality assurance and mitigate process risk while guaranteeing the desirable economic performance. Flexibility analysis is one approach to quantitively assess the capability of chemical process to guarantee feasible operation in face of variations on uncertain parameters. The aim of this paper is to provide the perspectives on the flexibility analysis for continuous pharmaceutical manufacturing processes. State-of-the-art and progress in the flexibility analysis for chemical processes including concept evolution, mathematical model formulations, solution strategies, and applications are systematically overviewed. Recent achievements on the flexibility/feasibility analysis of the downstream dosage form manufacturing process are also touched upon. Further challenges and developments in the field of flexibility analysis for novel continuous manufacturing processes of active pharmaceutical ingredients along with the integrated continuous manufacturing processes are identified.

关键词: Pharmaceuticals, Model, Optimization, Continuous manufacturing, Flexibility, Uncertainty

Abstract: Pharmaceutical continuous manufacturing, especially under the context of COVID-19 pandemic, is regarded as an emerging technology that can guarantee the adequate quality assurance and mitigate process risk while guaranteeing the desirable economic performance. Flexibility analysis is one approach to quantitively assess the capability of chemical process to guarantee feasible operation in face of variations on uncertain parameters. The aim of this paper is to provide the perspectives on the flexibility analysis for continuous pharmaceutical manufacturing processes. State-of-the-art and progress in the flexibility analysis for chemical processes including concept evolution, mathematical model formulations, solution strategies, and applications are systematically overviewed. Recent achievements on the flexibility/feasibility analysis of the downstream dosage form manufacturing process are also touched upon. Further challenges and developments in the field of flexibility analysis for novel continuous manufacturing processes of active pharmaceutical ingredients along with the integrated continuous manufacturing processes are identified.

Key words: Pharmaceuticals, Model, Optimization, Continuous manufacturing, Flexibility, Uncertainty

Wenhui Yang, Wuxi Qian, Zhihong Yuan, Bingzhen Chen. Perspectives on the flexibility analysis for continuous pharmaceutical manufacturing processes[J]. 中国化学工程学报, 2022, 41(1): 29-41.

Wenhui Yang, Wuxi Qian, Zhihong Yuan, Bingzhen Chen. Perspectives on the flexibility analysis for continuous pharmaceutical manufacturing processes[J]. Chinese Journal of Chemical Engineering, 2022, 41(1): 29-41.

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Perspectives on the flexibility analysis for continuous pharmaceutical manufacturing processes

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