Decision support tools for next-generation vaccines and advanced therapy medicinal products: present and future
Decision support tools for next-generation vaccines and advanced therapy medicinal products: present and future
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DOI：
10.1016/j.coche.2021.100689
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发表时间：
2021-05-27
影响因子：
6.6
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.
先进治疗药品（ATMP）是一类新型的生物疗法，利用突破性的临床干预措施来预防和治疗危及生命的疾病。同时，基于病毒载体和RNA的平台引入了新一代疫苗生产工艺。他们的临床成功导致了对ATMP需求的前所未有的增长，预计到2026年市场规模将达到96亿美元。本文讨论了如何数学模型可以作为工具，以协助决策的开发，制造和分销这些新产品类。强调了最近在工艺、技术经济和供应链建模领域的贡献。最后，我们提出并讨论了如何进一步推进过程系统工程，以支持先进疗法和疫苗的商业化。
Advanced Therapy Medicinal Products (ATMPs) are a novel class of biological therapeutics that utilise ground-breaking clinical interventions to prevent and treat life-threatening diseases. At the same time, viral vector-based and RNA-based platforms introduce a new generation of vaccine manufacturing processes. Their clinical success has led to an unprecedented rise in the demand that, for ATMPs, leads to a predicted market size of USD 9.6 billion by 2026. This paper discusses how mathematical models can serve as tools to assist decision making in development, manufacturing and distribution of these new product classes. Recent contributions in the space of process, techno-economic and supply chain modelling are highlighted. Lastly, we present and discuss how Process Systems Engineering can be further advanced to support commercialisation of advanced therapeutics and vaccines.