Recipe for Russian Insulin

Abstract


The share of locally produced insulin on the Russian market estimated at more than seven billion roubles in 2008 is, in reality, microscopic: national industry covers only 2 % of the market (see Table 1). This is unreasonably small, especially because а) Russian producers have enough capacity to produce insulin for the entire country, with similar or even higher quality as compared with foreign products, b) hundreds of thousands of insulindependent patients in some particular political or economical circumstances could suffer without this life-saving treatment. The World Health Organization recommends that any country with a population of more than 50 millions have its own manufacturing base for insulin. Anatoly Miroshnikov is an assistant director of the M.M. Shemiakin and Y.A. Ovchinnikov’ Institute of Bioorganic Chemistry of the RAS, which produces insulin with the trade name Insuran. He talks to Acta Naturae on why Russia needs its own factories for the production of genetically engineered drugs.

Medical histor y Anatoly Ivanovich, the share of Insuran on the insulin market is 1,04 %. Is it our limit– No. We can provide all the insulin the Russian Federation needs. But let me first recall a bit of history. In 1978, at the dawn of the era of biotechnology in the world pharmaceutical industry, our research institute also began successfully working in this direction. By 1990, only 3 years after the start of production of genetically engineered products in the U.S. and Denmark, we had also created an insulin-producing strain and started semi-industrial research at a biochemical complex in Stepnogorsk, Kazakhstan. At the time, our lag compared with the West was minimal. After 1991, everything went “dead.” Science and the chemical industry in Russia were on the verge of collapse, and western producers divided to our pharmaceutical market and, particularly, the market of insulin. In 2000 did Yurii Luzhkov, the mayor of Moscow, issue an instruction setting up experimental production of genetically engineered insulin- At IBC RAS, we received a 120 million rouble loan and began supplying short and longform insulin to Moscow clinics 3 years later. According to Luzhkov’s plan, we should have ramped up production to 300,000 phials a year. However, the city refused to buy such an amount of insulin: they argued that Moscow will slowly move away from phials insulin. Unfortunately, nobody gave us money for a cartridges production line. Now we are producing 95,000 phials a year and providing insulin to 15 % of Moscow patients suffering from diabetes. Have you had any reclamation on Insuran– Not one in the five years of manufacturing insulin. We produce it according the GMP standards, and each batch of 100 phials undergoes quality control.

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