Perspectives on the flexibility analysis for continuous pharmaceutical manufacturing processes

Yang, Wenhui; Qian, Wuxi; Yuan, Zhihong; Chen, Bingzhen

doi:10.1016/j.cjche.2021.12.005

Cited by 12 publications

(2 citation statements)

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“…Moreover, a good amount of work has been done in design space analysis for pharmaceutical processes using sampling-based techniques as well as equation-oriented optimization frameworks. [17][18][19] A common feature of the mentioned works is the analysis of continuous manufacturing, or a comparison between batch and continuous processing modes, reflecting the increased interest in transitioning to flow chemistry in pharmaceutical manufacturing from both academia and the industry.…”

Section: Introductionmentioning

confidence: 99%

“…Detailed dynamic modeling and nonsmooth representation of hybrid pharmaceutical processes have been studied by Patrascu et al 16 including DS and DP unit operations, where production scale was used as criterion for process optimization. Moreover, a good amount of work has been done in design space analysis for pharmaceutical processes using sampling‐based techniques as well as equation‐oriented optimization frameworks 17–19 . A common feature of the mentioned works is the analysis of continuous manufacturing, or a comparison between batch and continuous processing modes, reflecting the increased interest in transitioning to flow chemistry in pharmaceutical manufacturing from both academia and the industry.…”

Section: Introductionmentioning

confidence: 99%

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Techno‐economic analysis of dynamic, end‐to‐end optimal pharmaceutical campaign manufacturing using PharmaPy

et al. 2023

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Increased interest in the pharmaceutical industry to transition from batch to continuouos manufacturing motivates the use of digital frameworks that allow systematic comparison of candidate process configurations. This article evaluates the technical and economic feasibility of different end‐to‐end optimal process configurations, namely, batch, hybrid and continuous, for small‐scale manufacturing of an active pharmaceutical ingredient. Production campaigns were analyzed for those configurations containing continuous equipment, where significant start‐up effects are expected given the relatively short campaign times considered. Hybrid operating mode was found to be the most attractive process configuration at intermediate and large annual production targets, which stems from combining continuous reactors and semi‐batch vaporization equipment. Continuous operation was found to be more costly, due to long stabilization times of continuous crystallization, and thermodynamic limitations of flash vaporization. Our work reveals the benefits of systematic digital evaluation of process configurations that operate under feasible conditions and compliant product quality attributes.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%