生物技术
生化工程
上游(联网)
工艺工程
制造工程
计算机科学
工程类
生物
计算机网络
作者
J.W. Huebbers,Johannes F. Buyel
标识
DOI:10.1016/j.biotechadv.2020.107681
摘要
The market for biopharmaceuticals is dominated by recombinant proteins and is driven mainly by the development of vaccines and antibodies. Manufacturing predominantly relies on fermentation-based production platforms, which have limited scalability and suffer from high upstream process costs. As an alternative, the production of recombinant proteins in whole plants (plant molecular farming) provides a scalable and cost efficient upstream process because each plant functions as a self-contained bioreactor, avoiding costs associated with single-use devices and cleaning-in-place. Despite many proof-of-concept studies and the approval of a few products as medical devices, the only approved pharmaceutical proteins manufactured in whole plants have been authorized under emergency protocols. The absence of approvals under standard clinical development pathways in part reflects the lack of standardized process equipment and unit operations, leading to industry inertia based on familiarity with fermenter systems. Here we discuss the upstream production steps of plant molecular farming by transient expression in intact plants, including seeding, plant cultivation, infiltration with Agrobacterium tumefaciens, post-infiltration incubation, and harvesting. We focus on cultivation techniques because they strongly affect the subsequent steps and overall process design. We compare the benefits and drawbacks of open field, greenhouse and vertical farm strategies in terms of upfront investment costs, batch reproducibility, and decoupling from environmental impacts. We consider process automation, monitoring and adaptive process design in the context of Industry 4.0, which can boost process efficiency and batch-to-batch uniformity to improve regulatory compliance. Finally, we discuss the costs–benefit aspects of the different cultivation systems.
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