上游医药供应链中连续生产反应器技术的多标准评估

Parminder Kaur Aulakh, E. Settanni, J. Srai
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摘要

COVID-19大流行凸显了与基本活性药物成分(api)生产相关的上游药品供应链(PSC)的脆弱性。制定卫生对策的必要性为支持先进制造技术提供了新的动力,例如通过连续制造(CM)进行过程强化。最近的先进制造发展表明,采用CM比传统批量技术具有潜在优势。然而,在评估的早期阶段,详细的定量信息是有限的,并且基于多个相互冲突的标准选择特定的反应堆技术是具有挑战性的。为了解决这些早期制造技术选择的挑战,本文采用了层次分析法,整合了多个管理和工程标准。分析的重点是上游PSC制造中的反应器技术。研究结果表明,微反应器技术在所有方面都优于其他选择。然而,PSC管理方面的考虑在特定治疗领域引入了细微差别,例如抗病毒药物,其中复杂化学和单元操作灵活性之间的紧张关系可能有利于批量生产。对于镇痛药,在解决库存减少问题的同时,需要利用现有的生产基地,这有利于结合批次和CM元素的技术。研究丰富了先前基于体积-品种考虑的概念框架,为PSC中替代CM反应器技术的多方面评估提供了经验工作流。
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Multi-Criteria Assessment of Continuous Manufacturing Reactor Technologies in Upstream Pharmaceutical Supply Chains
The COVID-19 pandemic highlighted vulnerabilities in upstream pharmaceutical supply chains (PSC) associated with the manufacture of essential active pharmaceutical ingredients (APIs). The need to develop health countermeasures provided new impetus to supporting advanced manufacturing technologies such as process intensification through continuous manufacturing (CM). Recent advanced manufacturing developments suggest potential advantages in adopting CM over traditional batch technologies. However, at an early stage of evaluation detailed quantitative information is limited, and selecting specific reactor technologies based on multiple, conflicting criteria is challenging. To address these early-stage manufacturing technology selection challenges, this paper applies an Analytical Hierarchy Process approach, integrating multiple managerial and engineering criteria. The analysis focuses on reactor technologies in upstream PSC manufacturing. Findings suggest that microreactor technologies outperform alternatives all things considered. However, PSC managerial considerations introduce nuances in specific therapeutic areas e.g., antivirals where a tension between complex chemistry and the need for flexibility in unit operations may favour batch manufacturing. For analgesics the need to exploit the existing manufacturing base whilst addressing inventory reduction favour technologies that incorporate elements of batch and CM. Research enriches previous conceptual frameworks predicated on volume-variety considerations, providing an empirical workflow for the multi-faceted evaluation of alternative CM reactor technologies in PSC.
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