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

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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.