Department of Molecular and Cell Biology, University of Cape Town, Rondebosch, South Africa. ed.rybicki@ uct.ac.za
Plant Biotechnol J. 2010 Jun;8(5):620-37. doi: 10.1111/j.1467-7652.2010.00507.x. Epub 2010 Mar 11.
The concept of using plants to produce high-value pharmaceuticals such as vaccines is 20 years old this year and is only now on the brink of realisation as an established technology. The original reliance on transgenic plants has largely given way to transient expression; proofs of concept for human and animal vaccines and of efficacy for animal vaccines have been established; several plant-produced vaccines have been through Phase I clinical trials in humans and more are scheduled; regulatory requirements are more clear than ever, and more facilities exist for manufacture of clinic-grade materials. The original concept of cheap edible vaccines has given way to a realisation that formulated products are required, which may well be injectable. The technology has proven its worth as a means of cheap, easily scalable production of materials: it now needs to find its niche in competition with established technologies. The realised achievements in the field as well as promising new developments will be reviewed, such as rapid-response vaccines for emerging viruses with pandemic potential and bioterror agents.
利用植物生产高价值药物（如疫苗）的概念今年已经有 20 年的历史了，目前作为一种成熟的技术，它即将实现。最初依赖转基因植物的方法在很大程度上已经让位于瞬时表达；已经建立了人类和动物疫苗的概念验证以及动物疫苗的功效；已经有几种植物生产的疫苗在人体中进行了 I 期临床试验，更多的正在计划中；监管要求比以往任何时候都更加明确，并且有更多的设施用于制造临床级别的材料。最初的廉价可食用疫苗的概念已经让位于这样一种认识，即需要制定产品标准，而这些产品很可能是可注射的。该技术已经证明了其作为一种廉价、易于扩展的材料生产手段的价值：现在它需要在与成熟技术的竞争中找到自己的位置。本文将回顾该领域的已实现成就以及有前景的新进展，例如具有大流行潜力的新兴病毒和生物恐怖制剂的快速反应疫苗。
