Biopharma Company Nanolek Launches First Production Unit

23 December 2014

Nanolek, a RUSNANO portfolio company based in Russia’s Kirov Region, has launched its first production unit. The company was set up in 2011 in association with EPIDBIOMED group of companies and RUSNANO has contributed 1.28 billion rubles out of total 4 billion rubles invested. A revenue target in excess of 5 billion rubles has been set for 2018, of which 40% will be from sales of biotechnology drugs.

The launch ceremony was attended by the Envoy of the President of Russia to the Volga Federal District, Mikhail Babich, the Russian Minister of Industry and Trade, Denis Manturov, the Governor of Kirov Region, Nikita Belykh and the CEO of Nanolek, Mikhail Nekrasov.

The new facility uses high-tech equipment supplied by the Italian company IMA, one of the world’s leading manufacturers of machinery for the processing and packaging of pharmaceuticals. The facility consists of strictly separate clean rooms, each intended for a specific technical operation and separated from corridors and other rooms in the building by airlocks at gauge pressure, which minimizes the risk of contamination and allows different process stages and the manufacture of different products to occur simultaneously.

In 2015 Nanolek will use the Kirov site to produce statins, antihypertensives and antihistamines, as well as drugs that reduce the risk of thrombosis and improve microcirculation. A further seven products from the Russian official list of vital and essential drugs for the treatment of HIV, cancers and diseases of the central nervous system will be brought into production at the site in 2016-2017. The products have been developed under contract for the Russian Ministry of Industry and Trade as part of the Pharma 2020 national program, which Nanolek is helping to implement.

A second module, for biotechnology processes, is scheduled for launch at the Kirov site in Q3 2015. The second module will be capable of producing up to 20 drugs simultaneously. It will include clean rooms equipped with full-cycle equipment for the production of biotech drugs and vaccines (35 million bottles and 42 million pre-filled syringes per year), as well as a microbiology laboratory and a separate warehouse for biotechnology goods.

The Governor of Kirov Region, Denis Manturov said: “Nanolek’s biotechnology capacities will produce more affordable versions of 55 imported analogs in six treatment areas, strengthening capacity for preventing and curing illnesses that have major negative impact in our society.”

Nanolek is leading the way in Russia in the use of hermetic and disposable technologies for aseptic production (single use of container equipment, of bioreactors for the synthesis and production of solutions, and of packaging and pouring systems), enabling a broad range of products to be made without the risk of cross-contamination.

The CEO of Nanolek, Mikhail Nekrasov, said: “The Nanolek plant in Kirov Region is one of the biggest pharmaceutical production sites in Russia. The production module, which has just been launched, will produce solid-dosage drugs. The second module, to be launched in in 2015, will specialize in biotechnology production, which is still a rarity in Russia at present. Full-cycle production of complex vaccines will have major impact in protecting people from infectious diseases.”

Additional information

Reference

RUSNANO Joint-Stock Company was founded in March 2011 through reorganization of state corporation Russian Corporation of Nanotechnologies. JSC RUSNANO contributes to implementation of the state policy on the development of the nanotechnology industry by investing directly and through investment funds of nanotechnology in financially effective high-technology projects providing the development of new production facilities in the Russian Federation. Its primary investment focus is in electronics, optoelectronics and telecommunications, healthcare and biotechnology, metallurgy and metalwork, energy, mechanical engineering and instrument making, construction and industrial materials, chemicals and petrochemicals. 100 percent of RUSNANO’s shares are state owned. Thanks to RUSNANO’s investments, there are currently 103 factories and R&D Centers opened in 37 regions in Russia. JSC RUSNANO has profit for the last 5 years.

Management of assets of RUSNANO JSC is carried out by Limited Liability Company established in December 2013, RUSNANO Management Company. Anatoly Chubais is the Chairman of its Executive Board.

Work to establish nanotechnology infrastructure and carry out educational programs is fulfilled by RUSNANO’s Fund for Infrastructure and Educational Programs, which was also established during the reorganization of the Russian Corporation of Nanotechnologies.