Development of superior plant based manufacturing systems for production of bio-similar Trastuzumab drug

开发基于植物的优质制造系统，用于生产生物仿制药曲妥珠单抗药物

• 批准号: 479711-2015
• 负责人: Dixon, Michael
• 金额: $ 7.56万
• 依托单位: University of Guelph
• 依托单位国家: 加拿大
• 项目类别: Collaborative Research and Development Grants
• 财政年份: 2017
• 资助国家: 加拿大
• 起止时间: 2017-01-01 至 2018-12-31
• 项目状态: 已结题
• 来源: https://www.nserc-crsng.gc.ca/ase-oro/Details-Detailles_eng.asp?id=618321
• 关键词: Development; superior; plant; based; manufacturing

There are a limited number of studies that have examined how environmental parameters affect the yield of production of recombinant drugs in plant bioreactors (Hassan et al., 2012; Colgan et al., 2010; Stevens et al., 2000). In every one of these studies stable transgenic plants were used to express the protein of interest. PlantForm uses the preferred method of transient expression technology for production of recombinant antibody proteins in Nicotiana benthamiana, which allows for quicker production timelines and higher product yields. At this time, there is no available information on how environmental parameters such as growth conditions (e.g., lighting variables, spectrum and wavelength at various physiological growth stages, soil versus hydroponics, plant density, etc.), fertilizer and feeding formulations, gas exchange, day-night light cycle, and temperature affect target recombinant protein production through transient expression technology. As such, we and our industry partner PlantForm, propose to investigate these parameters towards the development of an optimized process for the production of therapeutic antibodies and in particular its lead drug candidate: plant produced bio-similar trastuzumab (Herceptin®), a therapeutic monoclonal antibody which may be used in the treatment and management of breast cancer patients.

有有限数量的研究已经检查了环境参数如何影响植物生物反应器中重组药物生产的产率（哈桑等人，2012; Colgan等人，2010; Stevens等人，2000年）。在这些研究中的每一个中，稳定的转基因植物用于表达感兴趣的蛋白质。PlantForm使用瞬时表达技术的优选方法在本氏烟草（Nicotiana benthamiana）中生产重组抗体蛋白，这允许更快的生产时间线和更高的产品产量。此时，没有关于环境参数如生长条件（例如，光照变量、不同生理生长阶段的光谱和波长、土壤与水培、植物密度等），肥料和饲养配方、气体交换、昼夜光循环和温度通过瞬时表达技术影响目标重组蛋白的生产。因此，我们和我们的行业合作伙伴PlantForm建议研究这些参数，以开发用于生产治疗性抗体的优化工艺，特别是其主要候选药物：植物生产的生物仿制药曲妥珠单抗（赫赛汀®），一种可用于治疗和管理乳腺癌患者的治疗性单克隆抗体。