Representatives of FSI «SID & GP» of Minpromtorg of Russia were present at the opening ceremony of a new workshop of the Nearmedic company
On 31 October, at the manufacturing site of the Nearmedic Pharma company in Kaluga region, a new workshop for reagents used in genetic identity evidence and propinquity establishment was opened. The event dedicated to launching of the new manufacturing line was attended by the Governor of Kaluga region, First Deputy Minister of Minpromtorg of Russia, the Director of the Industrial Development Fund and other high-level officials. On behalf of the State Institute of Drugs and Good Practices, congratulations to the managers and staff of the site were expressed by the Deputy Scientific Director Mr. Illarion Boiko.
A new workshop is a full-cycle facility where all components of test kits will be manufactured independently, using own technologies and starting materials from local manufacturers. Due to a unique technology of components vitrification, it is allowed to store novel test kits at room temperature, which is much cheaper than foreign alternatives requiring deep freeze storage and shipping conditions. The major field of application of the products manufactured at the site is determination of a person’s genetic profile, which is widely used in investigation of crimes, accidents, as well as in genetic studies.
The press-conference at the opening ceremony saw speeches of the General Director of Nearmedic Mr. Vladimir Nesterenko, the Production Manager Ms. Natalia Ermakova, the Deputy Scientific Director of FSI «SID & GP» Mr. Illarion Boiko and a member of the «Officers of Russia» presidium Mr. Vladimir Slepak.
In his speech, the Deputy Scientific Director of FSI «SID & GP» Mr. Illarion Boiko outlined that emerging of such a powerful tool for identity evidence in the Russian industry was the most wanted technology allowing to avoid dependence on foreign manufacturers.
«Technology and manufacturing solutions similar to those implemented by Nearmedic are necessary for our people, law-enforcement agencies, and military and security forces. They are key to meeting the needs of genetic identity and diagnostics» said Mr. Illarion Boiko. «Research results and proper technology solutions compliant both to GMP standards and ISO 18385 create well-deserved feelings of respect and pride, and expand our potential export capacities.»
Addressing the guests and the staff, the General Director of Nearmedic Mr. Vladimir Nesterenko mentioned that launching of such a system of reagents for genetic identity evidence within the country is very well-timed as today this market is fully import-depending. Currently, more than 90% of reagents for genetic identity evidence in the Russian market are supplied by foreign manufacturers. Launching of such new manufacture will reduce their share.
«We believe that we are capable of manufacturing a sufficient amount of reagents to meet the major needs in the country» said the General Director of the company at the press conference.
«Our site has been ISO 18385 certified, which is an international standard to assess the quality of products manufactured for use in forensic science. In Russia and CIS countries, we are first to have such a quality certificate.»
The annual production capacity of a new workshop is 15,000 kits for genetic identity evidence. Release of the first commercial batch is planned for 2019, while achievement of the designed full production capacity is forecasted to 2022.
- What is in the Programme of V GMP-conference?
- The rules of organizing and conducting inspections of drug manufacturers for the compliance with GMP requirements have been changed
- FSI “SID & GP” of the Ministry of Industry and Trade of the Russian Federation and company Sandoz held the first online forum on biotechnologies
- The SID&GP under the auspices of the Ministry of Industry and Trade of the Russian Federation conducted the first online inspection of Roche’s manufacturing site
- Rules for organizing and conducting inspection of pharmaceutical manufacturers for compliance with GMP requirements have been changed