NGO Microgen conducts a large-scale modernization of production according to GMP standards

Radical restructuring of production, which is like and so it works well, always requires a thoughtful and at the same time bold managerial decisions. And here we are talking about the system-for the entire industry enterprise. The efficiency of the "Microgen", producing 90% of vaccines for the national immunization schedule — it is also a question of epidemiological safety of the country.


 Photo source:rentschler.de


But the need to modernize production. Even just a little proud of the fact that in the most difficult post-Soviet years, Russia has managed to keep industrial and scientific potential of Immunobiology — what more domestic high-tech industry, other than space, can make that claim? Not enough experience and satisfaction from the fact that in 2003, the industry has managed to consolidate: then Federal State Unitary Enterprise "Microgen" united the 14 unitary enterprises across Russia, which in the 90s due to its fragmentation producing the same products and compete with each other, while a number of positions in the market is not enough.

Current strategy — to transform Russia‘s leading producer of immunobiological products in world-class company for the production of which borders simply do not exist.

This can be achieved only way: to convert the entire production, each laboratory, workshop and storage under the international standards of GMP. The task to make it to 2014 put the state before the whole Russian pharmaceutical industry. "Microgen" — a separate issue: its innovation development program until 2020, developed in July this year on the direct instructions of the President. Because of the special status of FSUE control of his work is carried out personally the Prime Minister.

"Someone from the domestic manufacturers may frightened by the prospect of joining the WTO. It only pleases us, says CEO NGO "Microgen" Lion Grigoriev. — We do not receive subsidies from the budget, compete with foreign producers on a legal framework for commercial tenders, and building a system of distributors. If you will be joining the WTO, "microgeny" after the transition to GMP open any markets. "

Russian vaccine purity and quality is not inferior to foreign analogues, and price competition is our manufacturer is able to withstand even the Indian companies. However, in the essence of the standards and GMP, they are barriers blocking the entrance to the outsiders have long established markets. That is, foreign buyers is not enough that the drug you have a high quality, they will not buy it if the conditions of production in at least one item do not meet the rules spelled out in detail. The transition to GMP — this is a major overhaul of each site and the entire system of enterprise management and quality control.


 Photo source:gmpnews.ru

The computer on the desk of Leo Grigorieva — a special program that allows real-time tracking of the situation in each of the branches. The first thing that started to come in 2009, "Microgen" head — improvement of corporate governance, which allows to trace the movement of each batch of manufactured drugs, any note. Control of trade and financial flows — is not the only, but important component of the enterprise. In just two years of its profits increased fivefold — almost 850 million rubles. Thus employees "Microgen" began to receive more — payroll was immediately increased by 20%. Department of Business Economics develops motivational schemes that tie wages to the result of a person of his work. Footage — by the way, among the employees 3 academicians, 13 professors, 26 doctors and 166 candidates of sciences — the main asset of the company.

In parallel, production optimization. Branches in Khabarovsk, Omsk and Yekaterinburg, it was decided to close it. On their sites produced a matter of names of drugs that were present in the lines of the more powerful branch. On each of the liquidated worked on productions 100-120. "In Omsk and Khabarovsk areas could not be left on the requirements of health, they are less than a hundred meters away from the houses, and the environmental norm — not less than three hundred meters", — explains Grigoriev.

But the real strategic move in order to make production as efficient, it was taken after a deep analysis of the decision to concentrate the bottling and packaging of the finished product in only two branches of the company. Create your own line of finishing operations to GMP standards at each production site would result in unnecessary cost. On this basis, it was decided that all production sites will turn out immunobiological products in thermal containers, which are then dumped in Tomsk, where he is in full swing installation of two lines of ampoule filling and final packaging by the standards of GMP — they will be launched in February 2012 . At another site in the center of Russia (now decided whether it will be in Nizhny Novgorod, Ufa and Perm) will be built workshop freeze-drying and packaging lines for drugs in powdered form, serving all of the power company. Freeze-drying can increase the shelf life of drugs at least twice.

Accordingly, at each production site under GMP plant will convert only the cultivation of vaccines, laboratory and warehouse. The special air conditioning system and water treatment, self-leveling floors, new equipment, plus such things invisible to the eye, as the introduction of new quality control system and electronic document — it is certainly too much. But according to GMP equip more bottling and packaging of finished products with warehouses in all the branches would cost much more. In this case, the proposed scheme does not discredit another Soviet idea to spread the production of essential drugs over the country, in case of emergency or war. Time between drugs "Microgen" still retains from Stavropol to Irkutsk.

Achieving a minimum cost while ensuring product quality — a necessary condition for competitiveness "Microgen" as it’s traditional markets of Russia, CIS and a number of former socialist countries and Latin America, and for expansion into new markets, particularly in South-East Asia and Africa. Vaccines are bought hundreds of thousands of doses, and the struggle between suppliers in tenders is for every penny, every dime. General Director of "Microgen" shows innovative packaging designed by order of the Italian company: small plastic syringe in a special capsule. It is easy to break off the ends of the capsule, the drug is administered to the patient from the syringe, whereupon the syringe is released. Comfortable and aesthetically pleasing. In well-known European manufacturers of vaccines, too, as a rule, in a disposable syringe, but he often made of glass. The cost of such a package — about 20 rubles.

"The cost of the proposed new package is approximately three rubles, the price is almost the glass vial with a disposable syringe — said Grigoriev. — During the year, and this is the shelf life of our products, most of the vaccine remains stable in a plastic syringe. There are, however, those that need to be packed only in glass. "

The general director focuses on an issue that could prevent the Russian industry to switch completely to GMP in 2014. According to standards, the formulations can be packaged only in ampules made of farmstekla firs
t hydrolytic class. In Russia there are companies that own the technology of its production, but so far it has not established, and, according to Grigorieva, to launch such a special and rather capital-intensive production without state support would be difficult.

Investments in the modernization of bottling and packaging in Tomsk, 8-storey building in Ufa branch of the enterprise, which produces flu vaccine, as well as conversion of land for production of BCG vaccine in Stavropol account for 1.7 billion rubles. Reinvested profits of the enterprise, borrowing from banks. In 2012 the planned large-scale modernization, which will require even more costly. Some of the money the company expects to raise as part of the federal program, which provides funding for one of the designated areas of the modernization of the economy. Manufacturing — that’s not all: "Microgen" develops 14 new drugs in the short-term needs of the National Immunization schedule is planned to cover completely. And 2020 is supposed to introduce 37 new products.

It is known that Russian producers often have little chance to compete with foreign companies, behind which a decade of experience in the open market. It is obvious that the immunobiological industry and its leading enterprise are not affected. For "microgeny ‘impressive long-term achievements of the national Immunobiology, which when converted skillful approach, not only in the value demanded by today’s market capitalization and the capacity of the Russian Federation, but also, and most importantly — provide a complete sanitary-epidemiological safety of the population of our country.

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Veronika Skvortsov, Deputy Minister of Health and Social Development of the Russian Federation:

— Supply of vaccines for the national immunization schedule — the question of national security and the protection of the health of its citizens. In the most difficult economic years in Russia managed to keep the manufacturing base and research capabilities immunobiological industry, which is led by the NGO "Microgen". The question today is already different. Russia’s largest producer of immunobiological products can compete in the global market, serving the needs of different countries in accordance with the concept of the WHO on the development of preventive medicine. For this purpose "Microgen" started the large-scale modernization of production in accordance with the standards of GMP. This work should be completed in the near future. Also, there is a development of some original drugs. Full output of enterprises in foreign markets would provide additional incentives for the development of the industry, which is strategic for our country.

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