Ma Julian K-C, Chikwamba Rachel, Sparrow Penny, Fischer Rainer, Mahoney Richard, Twyman Richard M
Department of Cellular and Molecular Medicine, St. George's Hospital Medical School, Cranmer Terrace, London, UK SW17 0RE.
Trends Plant Sci. 2005 Dec;10(12):580-5. doi: 10.1016/j.tplants.2005.10.009. Epub 2005 Nov 14.
Plant-derived pharmaceuticals are poised to become the next major commercial development in biotechnology. The advantages they offer in terms of production scale and economy, product safety, ease of storage and distribution cannot be matched by any current commercial system; they also provide the most promising opportunity to supply low-cost drugs and vaccines to the developing world. However, despite the promised benefits, the commercialization of plant-derived pharmaceutical products is overshadowed by the uncertain regulatory terrain, particularly with regard to the adaptation of good manufacturing practice regulations to field-grown plants. The success of such products also depends on careful negotiation of the intellectual property landscape, particularly the achievement of freedom-to-operate licenses for use in developing countries.
植物源药物有望成为生物技术领域的下一个重大商业发展方向。它们在生产规模和经济性、产品安全性、易于储存和分发方面所具有的优势是目前任何商业系统都无法比拟的；它们还为向发展中世界供应低成本药物和疫苗提供了最具前景的机会。然而，尽管有这些预期的好处，但植物源药品的商业化却因监管环境的不确定性而蒙上阴影，尤其是在将良好生产规范法规应用于田间种植植物方面。这类产品的成功还取决于对知识产权格局的谨慎协商，特别是在获得用于发展中国家的实施许可方面。
