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

研究环境参数如何影响植物生物反应器中重组药物产量的研究数量有限(Hassan等人，2012年；Colgan等人，2010年；史蒂文斯等人，2000年)。在每一项研究中，稳定的转基因植物都被用来表达感兴趣的蛋白质。PlantForm使用瞬时表达技术的首选方法在本氏烟草中生产重组抗体蛋白，这允许更快的生产时间和更高的产品产量。目前，还没有关于生长条件(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)、肥料和饲料配方、气体交换、昼夜光循环和温度等环境参数如何通过瞬时表达技术影响目标重组蛋白产量的信息。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：植物生产的生物类似曲妥珠单抗(Herceptin®)，这是一种可用于乳腺癌患者治疗和管理的治疗性单抗。

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.