The potential of plants as a system for the development and production of human biologics.
The potential of plants as a system for the development and production of human biologics.
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植物作为人类生物制剂开发和生产系统的潜力。
DOI：
10.12688/f1000research.8010.1
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发表时间：
2016-01-01
期刊：
影响因子：
--
通讯作者：
Davis, Keith R
中科院分区：
文献类型：
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作者：
Chen, Qiang;Davis, Keith R
ZMapp在2014-2016年埃博拉疫情期间作为一种潜在的救命药物的成功故事突显了植物制造生物制剂的前景日益光明。目前的植物表达平台提供了超出传统优势的低成本、高可扩展性、增加的安全性和真核蛋白质修饰的特征。已经开发了新型瞬时表达载体，其允许以前所未有的速度生产疫苗和治疗剂，以控制潜在的流行病或生物恐怖主义袭击。植物-宿主工程提供了一种用于生产具有独特且一致的哺乳动物翻译后修饰的蛋白质的方法，从而提供了开发相对于其哺乳动物细胞产生的对应物具有增加的功效的生物制剂的机会。最近的证据表明，植物蛋白可以作为食源性病原体的生物控制剂，进一步证实了植物蛋白生产的潜在效用。然而，解决商业规模生产的技术和监管挑战，获得大型制药公司的认可，以及获得美国食品和药物管理局对几种主要类别生物制剂的批准，是实现这项技术未开发潜力的关键步骤。
The growing promise of plant-made biologics is highlighted by the success story of ZMapp as a potentially life-saving drug during the Ebola outbreak of 2014-2016. Current plant expression platforms offer features beyond the traditional advantages of low cost, high scalability, increased safety, and eukaryotic protein modification. Novel transient expression vectors have been developed that allow the production of vaccines and therapeutics at unprecedented speed to control potential pandemics or bioterrorism attacks. Plant-host engineering provides a method for producing proteins with unique and uniform mammalian post-translational modifications, providing opportunities to develop biologics with increased efficacy relative to their mammalian cell-produced counterparts. Recent demonstrations that plant-made proteins can function as biocontrol agents of foodborne pathogens further exemplify the potential utility of plant-based protein production. However, resolving the technical and regulatory challenges of commercial-scale production, garnering acceptance from large pharmaceutical companies, and obtaining U.S. Food and Drug Administration approval for several major classes of biologics are essential steps to fulfilling the untapped potential of this technology.