Kirk Dwayne D, Webb Steven R
The Biodesign Institute and School of Life Sciences, Arizona State University, Tempe, 85287, USA.
Immunol Cell Biol. 2005 Jun;83(3):248-56. doi: 10.1111/j.1440-1711.2005.01340.x.
Significant potential advantages are associated with the production of vaccines in transgenic plants; however, no commercial product has emerged. An analysis of the strengths, weaknesses, opportunities and threats for plant-made vaccine technology is provided. The use of this technology for human vaccines will require significant investment and developmental efforts that cannot be supported entirely by the academic sector and is not currently supported financially by industry. A focus on downstream aspects to define potential products, conduct of additional basic clinical testing, and the incorporation of multidisciplinary strategic planning would accelerate the potential for commercialization in this field. Estimates of production cost per dose and volume of production are highly variable for a model vaccine produced in transgenic tomato, and can be influenced by the optimization of many factors. Commercialization of plant-made vaccine technology is likely to be led by the agricultural biotechnology sector rather than the pharmaceutical sector due to the disruptive nature of the technology and the complex intellectual property landscape. The next major milestones will be conduct of a phase II human clinical trial and demonstration of protection in humans. The achievement of these milestones would be accelerated by further basic investigation into mucosal immunity, the codevelopment of oral adjuvants, and the integration of quality control standards and good manufacturing practices for the production of preclinical and clinical batch materials.
转基因植物生产疫苗具有显著的潜在优势；然而，尚未出现商业产品。本文对植物源疫苗技术的优势、劣势、机遇和威胁进行了分析。将该技术用于人类疫苗需要大量投资和研发工作，而这无法完全由学术部门承担，目前也没有得到行业的资金支持。关注下游环节以确定潜在产品、开展更多基础临床试验以及纳入多学科战略规划，将加速该领域的商业化潜力。对于转基因番茄生产的一种模型疫苗，每剂生产成本和产量估计差异很大，且会受到许多因素优化的影响。由于该技术的颠覆性性质和复杂的知识产权格局，植物源疫苗技术的商业化可能由农业生物技术领域而非制药领域引领。下一个主要里程碑将是开展II期人体临床试验并证明对人类的保护作用。对黏膜免疫进行进一步基础研究、共同开发口服佐剂以及整合临床前和临床批次材料生产的质量控制标准及良好生产规范，将加速这些里程碑的实现。
