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The Emergency Response Capacity of Plant-Based Biopharmaceutical Manufacturing-What It Is and What It Could Be
Frontiers in Plant Science ( IF 4.1 ) Pub Date : 2020-09-24 , DOI: 10.3389/fpls.2020.594019
Daniel Tusé , Somen Nandi , Karen A. McDonald , Johannes Felix Buyel

Several epidemic and pandemic diseases have emerged over the last 20 years with increasing reach and severity. The current COVID-19 pandemic has affected most of the world’s population, causing millions of infections, hundreds of thousands of deaths, and economic disruption on a vast scale. The increasing number of casualties underlines an urgent need for the rapid delivery of therapeutics, prophylactics such as vaccines, and diagnostic reagents. Here, we review the potential of molecular farming in plants from a manufacturing perspective, focusing on the speed, capacity, safety, and potential costs of transient expression systems. We highlight current limitations in terms of the regulatory framework, as well as future opportunities to establish plant molecular farming as a global, de-centralized emergency response platform for the rapid production of biopharmaceuticals. The implications of public health emergencies on process design and costs, regulatory approval, and production speed and scale compared to conventional manufacturing platforms based on mammalian cell culture are discussed as a forward-looking strategy for future pandemic responses.



中文翻译:

基于植物的生物制药生产的应急能力是什么以及可能是什么

在过去的20年中,随着传播范围和严重程度的增加,出现了几种流行病和大流行病。当前的COVID-19大流行已经影响了世界上大多数人口,造成了数百万的感染,数十万的死亡以及大规模的经济破坏。伤亡人数的增加突显了迫切需要快速交付治疗剂,预防剂(如疫苗)和诊断试剂。在这里,我们从制造的角度回顾植物中分子农业的潜力,重点是瞬时表达系统的速度,容量,安全性和潜在成本。我们着重指出目前在监管框架方面的局限性,以及在未来将植物分子种植技术建立为全球性,分散的紧急响应平台,可快速生产生物药品。与基于哺乳动物细胞培养的传统制造平台相比,突发公共卫生事件对过程设计和成本,法规批准以及生产速度和规模的影响,是对未来大流行应对的前瞻性策略。

更新日期:2020-10-20
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