Plant cells are ideal bioreactors for the production and oral delivery of vaccines and biopharmaceuticals, eliminating the need for expensive fermentation, purification, cold storage, transportation and sterile delivery. Plant-made vaccines have been developed for two decades but none has advanced beyond Phase I. However, two plant-made biopharmaceuticals are now advancing through Phase II and Phase III human clinical trials. In this review, we evaluate the advantages and disadvantages of different plant expression systems (stable nuclear and chloroplast or transient viral) and their current limitations or challenges. We provide suggestions for advancing this valuable concept for clinical applications and conclude that greater research emphasis is needed on large-scale production, purification, functional characterization, oral delivery and preclinical evaluation.

译文

植物细胞是用于生产和口服递送疫苗和生物制药的理想生物反应器,无需昂贵的发酵,纯化,冷藏,运输和无菌递送。植物疫苗已经开发了二十年,但没有一个疫苗已经超过了I期。但是,目前有两种植物生物药物正在通过II期和III期人体临床试验。在这篇综述中,我们评估了不同植物表达系统(稳定的核和叶绿体或瞬时病毒)的优缺点及其当前的局限性或挑战。我们提供了一些建议,以推动这一有价值的概念在临床上的应用,并得出结论,需要在大规模生产,纯化,功能表征,口服给药和临床前评估方面给予更多的研究重点。

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