Department of Molecular Biotechnology and Genetics, Faculty of Biology and Environmental Protection, University of Lodz, Banacha 12/16, 90-237 Lodz, Poland.
Int J Mol Sci. 2022 Mar 17;23(6):3236. doi: 10.3390/ijms23063236.
Tremendous advances in crop biotechnology related to the availability of molecular tools and methods developed for transformation and regeneration of specific plant species have been observed. As a consequence, the interest in plant molecular farming aimed at producing the desired therapeutic proteins has significantly increased. Since the middle of the 1980s, recombinant pharmaceuticals have transformed the treatment of many serious diseases and nowadays are used in all branches of medicine. The available systems of the synthesis include wild-type or modified mammalian cells, plants or plant cell cultures, insects, yeast, fungi, or bacteria. Undeniable benefits such as well-characterised breeding conditions, safety, and relatively low costs of production make plants an attractive yet competitive platform for biopharmaceutical production. Some of the vegetable plants that have edible tubers, fruits, leaves, or seeds may be desirable as inexpensive bioreactors because these organs can provide edible vaccines and thus omit the purification step of the final product. Some crucial facts in the development of plant-made pharmaceuticals are presented here in brief. Although crop systems do not require more strictly dedicated optimization of methodologies at any stages of the of biopharmaceutical production process, here we recall the complete framework of such a project, along with theoretical background. Thus, a brief review of the advantages and disadvantages of different systems, the principles for the selection of elements for the expression cassettes, and available methods of plant transformation, through to the protein recovery and purification stage, are all presented here. We also outline the achievements in the production of biopharmaceuticals in economically important crop plants and provide examples of their clinical trials and commercialization.
在作物生物技术方面取得了巨大进展,这些进展与可用于特定植物物种转化和再生的分子工具和方法的可用性有关。因此,人们对植物分子农业的兴趣显著增加,旨在生产所需的治疗性蛋白质。自 20 世纪 80 年代中期以来,重组药物已经改变了许多严重疾病的治疗方法,如今已应用于医学的所有分支。现有的合成系统包括野生型或改良的哺乳动物细胞、植物或植物细胞培养物、昆虫、酵母、真菌或细菌。可育条件良好、安全性高以及生产成本相对较低等不可否认的优势,使得植物成为生物制药生产有吸引力且具有竞争力的平台。一些具有可食用块茎、果实、叶子或种子的蔬菜植物可能是理想的廉价生物反应器,因为这些器官可以提供可食用的疫苗,从而省略最终产品的纯化步骤。这里简要介绍了植物制药开发中的一些关键事实。尽管作物系统在生物制药生产过程的任何阶段都不需要更严格地专门优化方法,但我们在这里回顾了这样一个项目的完整框架,以及理论背景。因此,简要回顾了不同系统的优缺点、用于表达盒元件选择的原则以及植物转化的可用方法,直至蛋白质回收和纯化阶段,所有这些都在这里进行了介绍。我们还概述了在经济上重要的作物植物中生产生物制药的成就,并提供了其临床试验和商业化的例子。