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Challenges and opportunities in biopharmaceutical manufacturing control

•A perspective is provided on the control of biopharmaceutical manufacturing.•Microscale and modular plug-and-play unit operations are technologies of interest.•The uncertain nonlinear systems involve mixed continuous-discrete operations.•Process data analytics and adaptive and hybrid control strate...

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Bibliographic Details
Published in:Computers & chemical engineering 2018-02, Vol.110, p.106-114
Main Authors: Hong, Moo Sun, Severson, Kristen A., Jiang, Mo, Lu, Amos E., Love, J. Christopher, Braatz, Richard D.
Format: Article
Language:English
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Summary:•A perspective is provided on the control of biopharmaceutical manufacturing.•Microscale and modular plug-and-play unit operations are technologies of interest.•The uncertain nonlinear systems involve mixed continuous-discrete operations.•Process data analytics and adaptive and hybrid control strategies are discussed.•Novel protein separation methods are discussed that may significantly reduce costs. 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.
ISSN:0098-1354
1873-4375
DOI:10.1016/j.compchemeng.2017.12.007