Italian National Agency for New Technologies, UTBIORAD, CR Casaccia, Rome, Italy.
Expert Rev Vaccines. 2010 Aug;9(8):877-92. doi: 10.1586/erv.10.91.
The use of contained plant systems for the production of biopharmaceuticals represents a powerful alternative to current methods, combining the benefits of whole-plant systems and cell cultures. In vitro contained production systems include plant cell suspensions, hairy root cultures, novel plants grown in contained conditions and microalgae. These systems show intrinsic advantages, such as control over growth conditions, production in compliance with good manufacturing practice and avoidance of political resistance to the release of genetically modified field crops. At present, one of the two plant-produced vaccine-related products that have gone all the way through production and regulatory hurdles derives from tobacco cell suspensions, and the second is a human therapeutic enzyme, which is expected to reach commercial development soon and derives from carrot suspension cells. In the future, several other products from contained systems are expected to reach the clinical trial stage.
采用密闭式植物系统生产生物制药是当前方法的有力替代方案,它结合了全植物系统和细胞培养的优势。体外密闭式生产系统包括植物细胞悬浮液、发根培养物、在密闭条件下生长的新型植物和微藻。这些系统具有内在优势,例如可以控制生长条件,符合良好生产规范进行生产,避免因释放基因改造田间作物而产生政治阻力。目前,已经通过生产和监管障碍的两种与植物生产疫苗相关的产品之一源自烟草细胞悬浮液,另一种是人类治疗性酶,预计很快将进入商业开发阶段,源自胡萝卜悬浮细胞。未来,预计还有其他几种来自密闭系统的产品将进入临床试验阶段。