Russian biopharmaceutical company Nanolek (a joint venture between RusNano with Russian biotechnology company Epidbiomed) and privately-held US biotech firm Lentigen have signed a Memorandum of Understanding (MoU) on their intention to launch production of a novel VLP (virus-like particle)-based flu vaccine manufactured at Nanolek’s large-scale pharmaceutical production facility in Kirov, Russia.
Production will be based on use of a revolutionary, novel lentiviral system for efficient expression of the vaccine in human cell lines. This system provides biopharmaceutical products with beneficial properties, such as a fully human glycosylation profile, and production at high efficiency that will decrease the high costs of biopharmaceutical products. The system has being developed by Lentigen which will license vectors, cell lines, technologies, and relevant expertise to Nanolek.
According to the MoU, the license and technology transfer agreement will be signed in late 2013, GMP material will be produced and preclinical trials will be completed by late 2014, while the production launch and clinical trials are scheduled for 2015.
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