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

关于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 et al., 2012; Colgan et al., 2010; Stevens et al., 2000）。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使用首选的瞬时表达技术在烟叶中生产重组抗体蛋白，这使得生产时间更快，产品产量更高。目前，还没有关于生长条件（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态表达技术影响目标重组蛋白生产的信息。因此，我们和我们的行业合作伙伴PlantForm提议研究这些参数，以开发一种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药曲妥珠单抗（赫赛汀®），一种治疗性单克隆抗体，可用于治疗和管理乳腺癌患者。

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.