Posted: September 10, 2009

(Nanowerk News) A project for the production of vaccines and biopharmaceuticals has been approved by the Supervisory Council of RUSNANO. Project plans include development of two vaccines for human flu and bird flu and three biopharmaceuticals for treatment of cancer-related toxicity, boosting of the immune system and increasing the efficiency of antibacterial and antiviral drugs, and treatment of lower extremity ischemia and motor neuron disease.

RUSNANO and NTpharma intend to form a joint venture for putting the project to life. Research activity will be coordinated by the Gamaleya State Scientific Research Institute for Epidemiology and Microbiology of the Russian Academy of Medical Sciences of RAMS. Scientific support will also be provided by the Research Institute for Influenza of RAMS, the Molecular Genetics Institute of the Russian Academy of Science, the Scientific Center for Neurology of RAMS, the Herzen Moscow State Oncology Research Institute (Federal Agency for Public Health and Social Development), the Petrovsky Russian State Surgery Center of RAMS, and other scientific institutions.

The project budget totals 1,547 million rubles. RUSNANO will contribute 237 million rubles to obtain a 49% share of the joint enterprise charter capital and will also grant a loan of 1,063 million rubles for a period of seven years. In addition, NTpharma will provide 100 million rubles to the chartered capital and contribute its intellectual property appraised by Deloitte & Touche at 147 million rubles.

The project launch is scheduled for the first quarter of 2010 with target capacity being reached in the third quarter of 2012.

Two types of vaccines and biopharmaceuticals are planned for market introduction. The first type features self-assembling nanoparticles representing modified adenoviruses. While incapable of reproduction in living cells, these nanoparticles deliver the target gene. Using this gene, cells generate the protein needed to bring about a therapeutic effect or, in case of vaccination, trigger immune response. The second type of vaccine uses synthesized polysaccharide nanoparticles. Target protein molecules are attached to these nanoparticles with a special protein module (carbohydrate-binding domain). This technology allows for the generation of nanoparticles measuring 50-90 nanometers in diameter, the size necessary for recognition by cells responsible for primary immune response.

“Nanovaccines are more efficient than conventional vaccines in that they induce both humoral and cell-mediated immune response. They are also more convenient for usage as they may be applied in the form of nasal drops. The technology proposed would allow to reduce the time required for culturing vaccine strains from 60 to 28 days - vital when dealing with vaccines for pandemic flu strains,” emphasized one of the project originators, R&D Deputy Director of Gamaleya State Scientific Research Institute for Epidemiology and Microbiology, Boris Naroditsky.

According to Olga Shpichko, RUSNANO’s Managing Director, production will be established at 10 million packagings per year in accordance with international GMP standards. Once the Russian market is saturated, the possibility for entry to the world market for flu vaccines will be open, a market currently estimated at $3 billion and growing by 18% each year.