Laboratory of the IBCh first in Russia received a foreign order for preclinical testing of substances by world standards
Laboratory of Biological Tests of the Branch of the Institute of Bioorganic Chemistry (BICh) received an order from a European company for preclinical animal studies, which will be conducted in accordance with world standards. Thus, for the first time, Russia will export high-tech services such as pre-clinical research for foreign countries.
“Our Laboratory was the first in Russia to enter the European market, since until recently it was the only center in the country where preclinical tests were carried out in accordance with the principles of good Laboratory practice of the Organization for Economic Cooperation and Development (GLP OECD) and the guidelines of this organization (TG OECD),” says Arkady Murashev, head of the Laboratory of Biological Tests of BICh in Pushchino city. "That's why we managed to export such high-tech services as performing non-clinical studies conducted for a European company with the aim of registering the object under the study abroad.”
In 2005, the Laboratory for Biological Tests was accredited by the Association for the Assessment and Accreditation of Laboratory Animal Care International (AAALAC International). In 2013, the work of the Laboratory was recognized as being consistent with the principles of good laboratory practice (GLP), it means norms and rules that ensure the consistency and reliability of laboratory results. This allowed us to declare that the results of non-clinical studies carried out in this laboratory will be considered by regulatory bodies in the countries of the Organization for Economic Cooperation and Development (EU countries, USA, etc.). Finally, in 2014 the Laboratory was recognized for compliance with the principles of GLP in Russia, thanks to which the work on the creation of the National GLP system was completed in Russia. In February this year, during the Forum of the Russian Export Center “Made in Russia – Recognized Abroad”, the Laboratory for Biological Testing was noted as the only one among ten other centers that can export goods not only from abroad but also from non-clinical research services.
According to Murashev, the study will be conducted on rats grown in special conditions without pathogens (SPF animals) in the Nursery for Laboratory Animals of the BIBCh in Pushchino city, and will take six months after which the customer plans to register the test substance in the countries of the Organization for Economic Cooperation and Development: countries European Union, Japan, USA, Canada and others.
“The name of the company, the tested substance, as well as the price of the service are protected by trade secrets, so I can not announce them,” Arkady Nikolayevich said. “But now it becomes clear that this order will not be the only one for our Laboratory. This is only the first swallow, there will be a second one, but to make them bigger, state support for “oases of GLP research” is needed, there are only ten of them in the Russian Federation. I firmly believe that Russia has its export potential in this area, which must be realized by financing unique scientific units.“
Scientists are sure that the recognition by European countries of the research results which carried out in the laboratory in the Pushchino city will force domestic companies to think about using this base in their business projects, which will save them not only money but also time.