Insulin is a life-saving medicines, and WHO recommends that product yourself to those countries whose population exceeds 50 million. But despite the steady increase in incidence in Russia, the bulk of insulin purchased abroad. To overcome the dependence on imports to domestic production of the country insulin complete cycle, which will help ensure national security.
Full production of genetically engineered human insulin carries on an industrial scale domestic enterprise of JSC "National Biotechnology", located in the Moscow region Obolensk. Here is the entire process, from the manufacture of the substance to the finished dosage form.
site of biosynthesis of "National Biotechnology"
Recently the company announced the construction of a new production facility for the production of medicaments for the treatment of diabetes and other socially significant diseases. The construction of high-tech automated production facility is in Obolensk Serpukhov, Moscow region, next to the existing plant "National Biotechnology".
The development of the original Russian technology, scientists have spent several years. And already in 2003 started the first commercial line, which produces 30 kg of substance genetically engineered human insulin in a year. Currently, based on the substance of the "National Biotechnology" at the facilities of the enterprise standard sample made of genetically engineered human insulin, which is the state standard sample and is used to test drugs, as produced in Russia and imported from abroad.
purification section of insulin
Today JSC "National Biotechnology" — the only Russian company producing industrial-scale genetically engineered human insulin full-cycle: from the synthesis of the substance to finished dosage forms. The company produces a standard sample of genetically engineered human insulin, which is the state standard samples and control organizations of the country is used for testing all produced in Russia and imported drugs into the country. The quality of a substance produced by JSC "National Biotechnology" praised the three independent certified laboratory in Germany — Proteome Factory AG, Protylic GmbH, Labor L + S AG, confirming its compliance with European and U.S. Pharmacopoeia.
portion of dosage forms
Capacity of the existing pilot production line for the production of genetically engineered human insulin is 30 kg of substance and 1 million bottles of finished dosage forms per year.
site preparation of solutions and handling of waste
finished goods warehouse
New capacity will enable the company to scale the existing production of genetically engineered human insulin, to launch industrial line cartridge form drugs, and start production of analog types of insulin. In addition, the new plant will produce original modern medicines for the treatment and prevention of diabetes and other socially significant diseases.
The new plant's production capacity will be 20 million vials and 5 million cartridges a year. Investment in the first phase of construction exceeds 400 million rubles. Completion of construction and commissioning of the production site is scheduled in the II quarter of 2012. The layout of production facilities, the placement of equipment and its equipment will be made taking into account the current version of the current Russian regulations and standards, including the EU Guidelines on the "Rules of the proper production of drugs" of the Commission of the European Communities (GMP EU).
"Construction of a new production facility needed in view of the company's plans to expand the capacity and production of innovative drugs that are under development, — The director of "Geropharm" (which is a strategic partner of the "National Biotechnology"), Petr Rodionov. — In the scale of Russian production of high quality domestic genetically engineered human insulin complete cycle and construction of a new industrial complex — one more step towards the implementation of the program of import substitution and ensuring drug safety of the country. "
JSC "National Biotechnology" is 10 years old
Ltd. "Information and Advertising Agency" Mosaic ";