Merlin Matilde, Pezzotti Mario, Avesani Linda
Department of Biotechnology, University of Verona, Strada Le Grazie, 15, 37 134, Verona, Italy.
Br J Clin Pharmacol. 2017 Jan;83(1):71-81. doi: 10.1111/bcp.12949. Epub 2016 May 9.
Molecular farming is the use of plants for the production of high value recombinant proteins. Over the last 25 years, molecular farming has achieved the inexpensive, scalable and safe production of pharmaceutical proteins using a range of strategies. One of the most promising approaches is the use of edible plant organs expressing biopharmaceuticals for direct oral delivery. This approach has proven to be efficacious in several clinical vaccination and tolerance induction trials as well as multiple preclinical studies for disease prevention. The production of oral biopharmaceuticals in edible plant tissues could revolutionize the pharmaceutical industry by reducing the cost of production systems based on fermentation, and also eliminating expensive downstream purification, cold storage and transportation costs. This review considers the unique features that make plants ideal as platforms for the oral delivery of protein-based therapeutics and describes recent developments in the production of plant derived biopharmaceuticals for oral administration.
分子农业是指利用植物生产高价值重组蛋白。在过去25年里，分子农业通过一系列策略实现了药用蛋白的低成本、可扩展且安全的生产。最有前景的方法之一是利用表达生物制药的可食用植物器官进行直接口服给药。这种方法在多项临床疫苗接种和耐受性诱导试验以及多项疾病预防的临床前研究中已被证明是有效的。在可食用植物组织中生产口服生物制药，有望通过降低基于发酵的生产系统成本，并消除昂贵的下游纯化、冷藏和运输成本，给制药行业带来变革。本文综述了使植物成为基于蛋白质的治疗药物口服给药理想平台的独特特性，并描述了用于口服给药的植物源生物制药生产的最新进展。
