Resilience and risk analysis of fault-tolerant process control design in continuous pharmaceutical manufacturing

Su, Qing; Moreno, Mariana; Ganesh, Sudarshan; Reklaitis, Gintaras V.; Nagy, Zoltán K.

doi:10.1016/j.jlp.2018.07.015

Cited by 14 publications

(1 citation statement)

References 23 publications

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“…In a similar fashion, PSE researchers are also looking to quantify parameter uncertainty and its impact on product and process performance [74,75]. From an operational standpoint, many groups are developing using digital twins for the design of optimal operating setups, optimisation profiles [76][77][78][79], and smart controllers [80][81][82] that can operate bypassing measurement unavailability.…”

Section: Assisting Digitalisation In Pharmaceutical Industry Via Procmentioning

confidence: 99%

Emerging Challenges and Opportunities in Pharmaceutical Manufacturing and Distribution

et al. 2021

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The rise of personalised and highly complex drug product profiles necessitates significant advancements in pharmaceutical manufacturing and distribution. Efforts to develop more agile, responsive, and reproducible manufacturing processes are being combined with the application of digital tools for seamless communication between process units, plants, and distribution nodes. In this paper, we discuss how novel therapeutics of high-specificity and sensitive nature are reshaping well-established paradigms in the pharmaceutical industry. We present an overview of recent research directions in pharmaceutical manufacturing and supply chain design and operations. We discuss topical challenges and opportunities related to small molecules and biologics, dividing the latter into patient- and non-specific. Lastly, we present the role of process systems engineering in generating decision-making tools to assist manufacturing and distribution strategies in the pharmaceutical sector and ultimately embrace the benefits of digitalised operations.

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