On the basis of the pharmaceutical complex of the group of companies “R-Pharm” for the production of finished dosage forms in Yaroslavl, a solemn opening of a new line for the production of therapeutic proteins. The ceremony was attended by Chairman of the Board of Directors of group of companies “R-Pharm” Alexey Repik and CEO Vasily Ignatiev, Deputy Minister of industry and trade of the Russian Federation Sergey Tsyb, Director of Department of development of pharmaceutical and medical industry of Ministry of industry and trade of the Russian Federation Olga Kolotilova, Director of the Department of drug supply and regulation of medical devices circulation of the Ministry of health of Russia Elena Maksimkina, Director General of fsbi “State Institute of drugs and good practices” Vladislav Shestakov as well as Director of GE Healthcare Life Sciences in Russia/CIS Andrey Demurin. The event was held in the framework of the first national GMP conference in Yaroslavl.The desire to reduce operating costs, and hence reducing the cost of treatment of patients requires improved ways of producing drugs. Biopharmaceutical companies worldwide are looking for possibilities of increasing production flexibility in full compliance with the international quality standards. To this end, the company “R-Pharm” has decided to equip the line of production of therapeutic proteins in Yaroslavl integrated FlexFactory platform, the development division of GE Healthcare Life Sciences. Total investment in the project of “R-Pharm” has made over 1.5 billion rubles.
This platform is based on the use of innovative, so-called “disposable technology”, allows you to quickly accumulate considerable volumes of monoclonal antibodies and other biotech products. Unlike standard solutions, “disposable technology” enables significant savings of resources and time. At all stages of production (cultivation, purification, chromatography) are disposable items that after use are promptly disposed of and replaced by new ones, without requiring time-consuming and costly cleaning. “Disposable technology” provides flexibility in the modification of production processes, and if necessary, the possibility of rapid changes in the production of new products. Unified automation system enables to control the whole course of production and adjust individual processes, which facilitates the mounting and installation of the equipment and its use in the enterprise. In addition, “disposable technology” allow to exclude the possibility of contamination of the resulting products and to reduce the cost of cleaning the process line after each new launch of a series of the drug.
FlexFactory opens the possibility of the most rapid commissioning: from initial design to full certification and production readiness to launch takes an average of 12 months, significantly less than required to create a traditional line. In Yaroslavl the installation of innovative equipment began in the spring of 2015, and by October was confirmed by its functionality. This will allow us to begin pilot production and first industrial series for pre-clinical testing in early 2016.
The launch of a new line of biopharmaceutical drugs is an important step for serial production in Russia, of biological products, including innovative products and bio analogues with high export potential. The production line was qualified in accordance with the requirements of GMP.
According to Sergey Tsyb, Deputy Minister of industry and trade of the Russian Federation, “domestic companies actively use the support tools in the framework of the state Program on development of pharmaceutical and medical industry of the program “Pharma-2020”. Part of this program is the company “R-farm”, one of the largest investors in the region. Open platforms such as FlexFactory is an argument in favor of the fact that we chose the right guidance, goal setting, and so companies are actively helping us to reach those figures who stand before us in the framework of “Pharma-2020″”.
“The prospect presented in the Yaroslavl production technology of proteins is that biological products can be used to treat large number of diseases. Moreover, it is through the practical application of such drugs in modern medicine was able to find answers to many unanswerable are still problems in the field of treatment of oncological, cardiovascular, immune and other socially significant diseases, said during the opening lines Chairman of the Board of Directors of”R-Pharm” Alexey Repik.
“We are pleased to announce the launch of an innovative line for the production of highly effective drugs for the treatment of autoimmune diseases and cancer. The need of the health care system in modern treatment methods continues to grow, underlining the need for new development and improvement of diagnostic and therapeutic aid,”– said General Director of “R-Pharm” Vasily Ignatyev “R-Pharm”.
Andrew Demurin, Director of GE Healthcare Life Sciences in Russia/CIS, said: “We are proud to offer innovative solutions for key challenges facing the pharmaceutical industry in the context of the state program “Pharma 2020”. The discovery in Yaroslavl production line, equipped with GE Healthcare technology FlexFactory is an important event for national healthcare. The line capacity is 2000 liters per year – that means that the Russian patients will be provided with high-quality drugs in sufficient quantity.
About group of companies “R-Pharm”
“R-Pharm” – Russian high-tech pharmaceutical company. The company’s mission is to ensure the availability of innovative therapies for patients in Russia. The employ more than 3500 highly qualified specialists. “P-farm” on the territory of Russian Federation, CIS, USA, Germany, Japan, Turkey and India. There are more than 60 branches and representative offices. The main activities are: production of finished dosage forms, active pharmaceutical ingredients of chemical nature and biotechnological substances, research and development of innovative medicines and technologies, bringing to market modern medicines, as well as education and training of specialists for pharmaceutical industry and health care. www.r-pharm.com
FlexFactory is a fully integrated optimized a biotechnological platform that allows manufacturers to quickly and easily create automated biopharmaceutical manufacturing. Line enables a quick start of production of key biological drugs such as monoclonal antibodies and vaccines, from the cultivation of the cell culture and ending with the preparation of bulk formulations. Equipment FlexFactory is based on the “disposable technology”, which allows to achieve significant savings in time, capital costs and industrial costs in comparison with traditional stainless steel equipment. The line includes the equipment of technological processes, as well as all necessary automation components and control for the complete cycle of production of biological preparations. The ability to scale the FlexFactory platform significantly reduces the time of transition from production of one product to another. It can also be modified according to customer requirements to match the tasks of new or existing industrial enterprises. The experts from GE Healthcare Life Sciences to conduct training and provide consulting and service support on all stages of creation and operation of the equipment.