Posted: June 3, 2010

(Nanowerk News) The Supervisory Council of the Russian Corporation of Nanotechnologies (RUSNANO) has approved the corporation's participation in a project to create a center for preclinical studies. The project's budget will total 1.6 billion rubles, from which RUSNANO will invest 228 million rubles in equity and extend a loan of 580 million rubles (19.3 million dollars). A project applicant, Investment Advisory Group (IAG), will contribute 52 million rubles in equity. A financial coinvestor will contribute 180 million rubles in equity and extend a loan of 19.3 million dollars.

This project's annual revenue is expected to reach 1.3 billion rubles by 2015. Approximately half of this revenue will come from conducting preclinical tests under foreign contracts.

After passing an external audit the center will be Russia's first Contract Research Organization (CRO) to offer a full range of preclinical tests that conform to Good Laboratory Practice (GLP).

Academician Mikhail Kirpichnikov of the Lomonosov Moscow State University (MSU) Biology Department will head scientific oversight for this project. He will be working with leading chemico-biological institutes of the Russian Academy of Sciences (RAS), such as: Institute of Physiologically-Active Materials (IPAM RAS), Zelinsky Institute of Organic Chemistry RAS, Nesmeyanov Institute of Organoelemental Compounds RAS, Shemyakin-Ovchinnikov Institute of Bioorganic Chemistry RAS, etc.

The Lovelace Respiratory Research Institute (LRRI) from New Mexico, USA, will provide technical expertise for this project. With more than 23 years of experience in preclinical studies according to GLP standards, LRRI will outsource some of its own contract work to the new center. In order to create a quality control system, LRRI will train the new center's personnel, ensure conformance with GLP, as well as prepare the center for an audit by the US Food and Drug Administration (FDA) and by Organization for Economic Cooperation and Development (OECD) regulatory agencies.

The center will be built in Dubna, a city near Moscow with high concentration of research and development facilities. The center's construction project is being designed by Henningson, Durham & Richardson, International, one of the world's leading firms specializing in the design and construction of high-technology academic laboratory complexes. Over it's 90-plus year history this company has completed projects in nearly every state in the USA and in 60 other countries. The complex's total area, including testing laboratories, logistical and other auxiliary facilities, will be about 10,000 sq.m.

The center will focus in nanotoxicology studies, including nanoparticle safety testing, certification and preclinical testing of nanosubstances, nanomedical preparations and nanovaccines for safety, efficacy and adherence to technological parameters. For this purpose, the center will be equipped with additional laboratories and instruments to work with cell cultures, perform electron microscopy studies and specialized chemical analysis of nanomaterials.

"This project should play an important role in the development of domestic innovative pharmaceuticals," Olga Shpichko, RUSNANO Managing Director says. "According to the Russian pharmaceutical sector development strategy Pharma-2020, more than 1,000 preclinical studies should be conducted annually in Russia by 2015. About one-quarter of these tests will require the new center's full cycle of high-quality services."

"The preclinical studies center will specialize in safety of innovative nanoproducts. It will serve as a springboard for world market entry of prospective new Russian products, and at the same time attract foreign product innovations to Russia," states Yoanna Gouchtchina, General Director of IAG. "While developing modern industrial projects in Russia, IAG has long eyed the commercial potential of Russia's preclinical testing market. Even conservative estimates of this project's economic feasibility left no room for doubt that such a high-technology enterprise could be profitable. Attracting RUSNANO as a strategic partner, and the use of RUSNANO's financial and organizational resources, will undoubtedly help to overcome any possible barriers to the new center's establishment on the Russian market."

"The Lovelace Respiratory Research (LRRI) Institute is pleased to learn that such an important project as the creation of the first in Russia Preclinical Nanotoxicology Research Center is moving forward," says LRRI's President, Robert Rubin. "LRRI is one of the leading research institutes in the study of the physicochemical properties and toxicology of nanomaterials of all types under Good Laboratory Practice and other international standards. We are honored to collaborate with IAG, RUSNANO, and leading Russian Scientific Institutions such as the Lomonosov Moscow State University Biology Department in the development of this new exciting high technology scientific center."