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Klimyuk, V., Gleba, Y.

The transient expression system magnICON^® is a versatile technology that allows to speed up the R&D process and industrial scale production of recombinant proteins in plants. It is perfectly suited for production of so-called “rapid response” proteins (e.g. antigens for seasonal and pandemic flu vaccines, vaccines for bio-defense, recombinant proteins for patient-specific immunotherapy, etc) that have to be available for application on short notice.

We have developed a manufacturing process, which utilizes magnICON^® technology and enables production of individualized medicine in a matter of weeks after obtaining starting material for cloning gene of interest. In addition, we have designed and constructed a Clinical Manufacturing Facility to produce samples for clinical trials under cGMP. The development of rapid and high-throughput manufacturing process for patient-specific vaccines will be presented as an example of potential application for magnICON^® technology. The process allows to rapidly produce vaccines for treatment of Non-Hodgkin’s Lymphoma (NHL) and consists of three distinct stages: a/ identification and cloning of patient–specific variable regions of idiotype immunoglobulin (Ig); b/ plant agro-infiltration and idiotypic Ig accumulation; c/ downstream purification, formulation, fill and finish. Stage (a) of the process is unique for patient-specific NHL vaccine production, while stage (b) is broadly applicable for magnICON^®-based production and includes use of an industrial Agrobacterium strain and custom-designed equipment for agro-infiltration of plant material in an efficient and contained manner.

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