期刊
COMPUTERS & CHEMICAL ENGINEERING
卷 110, 期 -, 页码 106-114出版社
PERGAMON-ELSEVIER SCIENCE LTD
DOI: 10.1016/j.compchemeng.2017.12.007
关键词
Biopharmaceuticals; Biomanufacturing; Biopharmaceutical manufacturing; Continuous manufacturing; Protein crystallization; Process data analytics
资金
- Defense Advanced Research Projects Agency (DARPA)
- U.S. Army Medical Research and Material Command (MRMC)
- Army Research Office (ARO) [N66001-13-C-4025]
This article provides a perspective on control and operations for biopharmaceutical manufacturing. Challenges and opportunities are described for (1) microscale technologies for high-speed continuous processing, (2) plug-and-play modular unit operations with integrated monitoring and control systems, (3) dynamic modeling of unit operations and entire biopharmaceutical manufacturing plants to support process development and plant-wide control, and (4) model-based control technologies for optimizing startup, changeover, and shutdown. A challenge is the ability to simultaneously address the uncertainties, nonlinearities, time delays, non-minimum phase behavior, constraints, spatial distributions, and mixed continuous-discrete operations that arise in biopharmaceutical operations. The design of adaptive and hybrid control strategies is discussed. Process data analytics and grey-box modeling methods are needed to deal with the heterogeneity and tensorial dimensionality of biopharmaceutical data. Novel bioseparations as discussed as a potential cost-effective unit operation, with a discussion of challenges for the widespread application of crystallization to therapeutic proteins. (c) 2017 Elsevier Ltd. All rights reserved.
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