Gene technology has facilitated the biologization of manufacturing, i.e. the use and production of complex biological molecules and systems at an industrial scale. Monoclonal antibodies (mAbs) are currently the major class of biopharmaceutical products, but they are typically used to treat specific diseases which individually have comparably low incidences. The therapeutic potential of mAbs could also be used for more prevalent diseases, but this would require a massive increase in production capacity that could not be met by traditional fermenter systems. Here we outline the potential of plants to be used for the very-large-scale (VLS) production of biopharmaceutical proteins such as mAbs. We discuss the potential market sizes and their corresponding production capacities. We then consider available process technologies and scale-down models and how these can be used to develop VLS processes. Finally, we discuss which adaptations will likely be required for VLS production, lessons learned from existing cell culture-based processes and the food industry, and practical requirements for the implementation of a VLS process.

基因技术促进了制造业的生物化，即以工业规模使用和生产复杂的生物分子和系统。单克隆抗体 (mAb) 是目前生物制药产品的主要类别，但它们通常用于治疗个别发生率相对较低的特定疾病。mAb 的治疗潜力也可用于治疗更普遍的疾病，但这需要大幅提高生产能力，这是传统发酵罐系统无法满足的。在这里，我们概述了植物用于超大规模 (VLS) 生产生物制药蛋白质（如 mAb）的潜力。我们讨论了潜在的市场规模及其相应的生产能力。然后我们考虑可用的工艺技术和缩小模型，以及如何使用这些技术来开发 VLS 工艺。最后，我们讨论了 VLS 生产可能需要哪些适应、从现有的基于细胞培养的过程和食品行业中吸取的经验教训，以及实施 VLS 过程的实际要求。