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.

Advanced Therapy Medicinal Products (ATMPs) 是一类新型的生物疗法，它利用开创性的临床干预措施来预防和治疗危及生命的疾病。同时，基于病毒载体和基于 RNA 的平台引入了新一代疫苗制造工艺。他们的临床成功导致需求空前增加，预计到 2026 年，ATMP 的市场规模将达到 96 亿美元。 本文讨论了数学模型如何作为工具来辅助开发、制造和决策制定。这些新产品类别的分布。突出显示了过程空间、技术经济和供应链建模方面的最新贡献。最后，