Center for Preclinical Research of Nanomedical Drugs
The center, which will be built in Dubna near Moscow, is expected to pay special attention to nanotoxicology (safety studies of nanoparticles), as well as certification and preclinical studies of nanosubstances, nanomedical drugs and nanovaccines for safety, efficacy and compliance with technological parameters. The project provides additional laboratories and equipment for work with cell cultures, electron microscopy and specialized chemical analysis of nanomaterials.
The newly created center, after passing an external audit, will become the first contract research organization in Russia that provides a full cycle of preclinical studies according to the rules of good laboratory Practice (GLP – Good Laboratory Practice).
The scientific supervision of the project is carried out by the Faculty of Biology of Lomonosov Moscow State University under the leadership of Academician M.P. Kirpichnikov, in cooperation with leading chemical and biological institutes of the Russian Academy of Sciences such as: Institute of Physiologically Active Substances of the Russian Academy of Sciences (IFAV RAS), Institute of Organic Chemistry named after N.D. Zelinsky of the Russian Academy of Sciences, Institute of Organoelement Compounds named after A.N. Nesmeyanova RAS, Institute of Bioorganic Chemistry named after M.M. Shemyakin and Yu.A. Ovchinnikov RAS, etc.
The Lovelace Respiratory Research Institute (LRRI) from New Mexico, USA, is the executive expert on the project. The institute, which has been conducting preclinical research according to GLP standards for more than 23 years, will transfer part of its own orders to the center being created. In order to build a quality management system, LRRI will train the center's staff, verify compliance with GLP, and prepare the center for an audit by the U.S. Food and Drug Administration (FDA) and the regulatory authorities of the OSER.
The center is designed by Henningson, Durham & Richardson international, one of the world's leading firms specializing in the design and construction of high-tech research and laboratory complexes. Over its more than 90-year history, the company has implemented projects in almost every US state and 60 countries around the world. The total area of the complex, including research laboratories, logistics and other auxiliary facilities, will be about 10,000 sq.m.
"The project should play an important role in the development of domestic innovative pharmaceuticals," says Olga Shpichko, Managing Director of RUSNANO. – According to the development strategy of the pharmaceutical industry "Pharma 2020" by 2015, more than 1,000 preclinical studies should be conducted annually in Russia. Of these, about a quarter will require a full cycle at a high level of quality provided by the center."
"The Preclinical Research Center will specialize in the safety of innovative nanoproducts. It will become a springboard for the entry of promising Russian developments into the world market and at the same time attract foreign innovative projects to Russia – emphasizes Ioanna Gushchina, Director General of the IAG. – Developing modern production projects in Russia, IAG has long seen the commercial potential of the Russian preclinical research market. Even conservative calculations of the economic efficiency of the project did not raise doubts about the profitability of such a high-tech enterprise. The involvement of RUSNANO as a strategic partner and the use of the financial and organizational resources of the corporation will undoubtedly help to overcome possible barriers in the formation of the company in the Russian market.
"The Lovlas Institute of Respiratory Research welcomes the development of such an important project as the creation of Russia's first center for preclinical research in the field of nanotoxicology," says LRRI President Robert Rubin. "LRRI is one of the leading institutes in the study of physicochemical characteristics and safety of nanomaterials of all types in accordance with GLP and other international standards. Participation in the formation of this new high–tech center in cooperation with IAG, RUSNANO and leading Russian research organizations, such as the Faculty of Biology of Lomonosov Moscow State University, is a great honor for us."
The project to create a preclinical research center was approved by the Supervisory Board of RUSNANO. The total budget of the project will be 1.6 billion rubles. LLC "Investment Advisory Group" (IAG), the applicant of the project, will contribute 52 million rubles to the authorized capital of the project.
Investment Advisory Group LLC is an investment company with offices in Moscow and New York. IAG specializes in attracting investments, commercial real estate development, construction, business start-up, project implementation and doing business in the regions of Russia. Since 2002, the company has attracted more than $200 million to the Russian and CIS markets. Among the implemented Russian projects are the AVON cosmetics factory (Moscow Region), the ARNEG refrigeration plant (Moscow Region) and the technopark in Obninsk (Kaluga Region).
RUSNANO will contribute 228 million rubles to the authorized capital and provide a loan of 580 million rubles ($19.3 million in ruble equivalent). The co–investor, OJSC URALSIB, will contribute 180 million rubles to the authorized capital and will also provide a loan of $ 19.3 million. The annual revenue of the project by 2015 is projected at 1.3 billion rubles. About half of this volume will be the export of services – the implementation of preclinical studies on orders from foreign companies.
Portal "Eternal youth" http://vechnayamolodost.ru based on the materials of the RUSNANO press center
03.06.2010