The official ceremony marking the opening of the cutting-edge
high-tech complex “GEROPHARM-Bio”, JSC, was held on October 2, 2013; it
is the first Russian full-cycle plant manufacturing genetically
engineered human insulin: from the substance synthesis to the finished
dosage form. The ceremony was held within the Company’s production
complex premises located at Obolensk (the Moscow Region, the Serpukhov
The GEROPHARM-Bio plant is a large investment project which was
implemented as part of the Federal Strategy PHARMA-2020. The project was
completed in a relatively short period of time. The construction works
began in 2011. The project investments amounted to RUB 1.5 billion. The
plant has a total area of 2.5 ha. The area of its production premises is
approx. of 10,000 sq.m. The plant will allow to adjust the existing
production of genetically engineered human insulin, to launch a fully
automated line manufacturing the drug in cartridges and vials, as well
as to set up production of new advanced products for the treatment of
socially significant diseases, including diabetes. The expected
production volume will be 25 mln vials and 5 mln cartridges per year.
Most of the tasks in the plant are performed by automated manufacturing
systems. The production is organized in accordance with GMP standards.
The commissioning of the “GEROPHARM-Bio”, JSC plant is included in the
2013-2018 Activity Plan of the Ministry of Industry and Trade of the
Russian Federation. The plant is a unique one not only in the Moscow
Region, but also in Russia, as it creates the conditions for the drug
safety; it is the first plant which locates all the stages of socially
significant drug production within the country and ensures its
independence from foreign suppliers of raw materials.
The official ceremony was opened by the Governor of the Moscow Region A.Yu. Vorobiev. The following guests have participated in a symbolic commissioning of the plant: Assistant to the Minister of Health of the Russian Federation Ye.A. Maksimkina, Director of the Department of Chemical Engineering and Bioengineering Technology at the Ministry of Industry and Trade of the Russian Federation S.A. Tsyb, Head of the Social Control and Trade Administration of the Federal Antimonopoly Service of the Russian Federation T.V. Nizhegorodtsev, Executive Director of the Association of Innovative Regions of Russia, Chairman of the Supervisory Board of the Fund for Assistance to Small Innovative Enterprises in Science and Technology I.M. Bortnik.
Ye.A. Maksimkina in her speech emphasized the importance of the plant in providing the population with drugs to achieve full quality of life. S.A. Tsyb presented the speech on behalf of the Minister of Industry and Trade of the Russian Federation which emphasized the important role of the plant in the development of the pharmaceutical industry and improving the country’s drug safety.
T.V. Nizhegorodtsev noted in his speech that the new plant is “a
visible evidence of fair competition”, and that the competition in the
drug market is very complicated. “Our aim is to ensure easy marketing of
the company’s products throughout the country, as well as to gain
benefits from the competition for the health care system,” he said. “The
benefits from the competition are price reduction, release of
additional funds in the budget which could be used for improvement of
the quality of people’s lives.”
Congratulations were also made by the honoured guests at the event. Director of the Diabetes Institute, Deputy Research Director of the Federal State-Funded Institution “Endocrinology Research Center” of the Ministry of Health of the Russian Federation M.V. Shestakova said that the GEROPHARM-Bio plant is the first full-cycle plant, i.e. the plant which produces its own substance. She also noted that the country faces an enormous need for insulin: official data shows that there are 3.7 million people with diabetes in Russia, but it is 3 times smaller than the actual figures. Marina Vladimirovna ended her speech by wishing the company further progress in the field of insulin analogues development.
The Head of the Serpukhov District A.V. Shestun also emphasized the
particular importance of the opening unique high-tech production
facilities in the region, as well as in terms of creating new work
Deputy Chairman of the State Duma Committee on Culture, People’s
Artist of the USSR I.D. Kobzon and Director of the Elena Obraztsova
Music Charity Foundation N.M. Ignatenko were the honoured guests at the
General Director of the Group of Companies “GEROPHARM” P.P. Rodionov
expressed his gratitude to all the guests for their congratulations and
said: “We are facing an ambitious challenge, and we will achieve the
objectives that have been set. The opening of the plant is just the
beginning. Next year we will start supplying our products as part of
disposable insulin pens. Along with that, we are working to develop the
most modern insulins, and we will soon begin registration of new
insulins in Russia, the insulins that patients need.”
After the opening ceremony all guests attended the organized tours of
the GEROPHARM-Bio plant. In addition to visiting the production premises
the guests were given a unique opportunity to see the exhibition of
works of the famous Russian photographer Valery Plotnikov. Photo project
“Diabetes in Persons” was initiated by “GEROPHARM” in order to attract
public attention to the problem of diabetes. The project involved the
people for whom diabetes had become a routine lifestyle forever, but it
had not taken their zest for life.
“GEROPHARM-Bio” JSC (formerly “National Biotechnologies” JSC) belongs to the Group of Companies “GEROPHARM”. In 1998, the company was initially established to meet the state’s ambitious objective which consisted in setting up a pilot production technology for genetically engineered human insulin as part of the program “Diabetes”. A key aspect is the company’s strategic independence from foreign suppliers. Establishment of new production not only implies providing modern drugs to the population, but also creating new work places. The plant will employ up to 260 highly qualified experts. The project was implemented under the auspices of several major financial institutions: Sberbank of Russia, a long standing partner of the Group of Companies “GEROPHARM”, the European Bank for Reconstruction and Development, as well as VTB Leasing.
“GEROPHARM-Bio” is currently producing short-acting insulin drugs under the trade mark Rinsulin R (solution) and intermediate insulin drugs under the trade mark Rinsulin NPH (suspension), which are manufactured by its own technology. Proteome Factory AG Berlin, Prolytic GmbH Frankfurt am Main, Labor L+S AG, three independent certified European laboratories, appreciated the quality of the genetically engineered insulin substance produced by “GEROPHARM-Bio” and declared it compatible with the U.S.and British Pharmacopoeias. Today, the product has registration in Ukraine and Kyrgyzstan, and is currently under registration in Kazakhstan and Vietnam. The company expects to be audited for compliance with GMP standards by the end of this year; this will expand greatly the Rinsulins’ export routes. Russian insulins provoke general public interest abroad: this fact is confirmed by the participation of the Group of Companies “GEROPHARM” in the following major international pharmaceutical exhibitions and congresses: CPhI South East Asia (Jakarta, Indonesia), BIO International Convention (Chicago, USA). The agreements on further cooperation with a number of companies from the South-East Asia region, Latin America and North Africa were signed as a result of these events.