Emerging Challenges and Opportunities in Pharmaceutical Manufacturing and Distribution
Emerging Challenges and Opportunities in Pharmaceutical Manufacturing and Distribution
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DOI：
10.3390/pr9030457
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发表时间：
2021-03-01
期刊：
影响因子：
3.5
通讯作者：
Papathanasiou, Maria M.
中科院分区：
文献类型：
--
作者：
Sarkis, Miriam;Bernardi, Andrea;Papathanasiou, Maria M.
个性化和高度复杂的药品配置文件的兴起需要在药品制造和分销方面取得重大进展。正在努力开发更灵活、更灵敏、更可重复的制造工艺，并将数字工具的应用与工艺单元、工厂和分销节点之间的无缝通信结合起来。在这篇文章中，我们讨论了高特异性和敏感性的新疗法如何重塑制药业中公认的范例。我们概述了最近在药品制造、供应链设计和运营方面的研究方向。我们讨论了与小分子和生物制品相关的局部挑战和机会，将后者分为患者和非特异性。最后，我们介绍了过程系统工程在生成决策工具方面的作用，以帮助制药部门的制造和分销战略，并最终接受数字化运营的好处。
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.