The start-up of the industrial-scale production lines was held in the presence of the investment advisor of the Nicaraguan Government, colleague Laureano Ortega, the Vice Minister of Health of the Russian Federation, Sergey Kraevoy, the President of the Nicaraguan Institute of Social Security, Dr. Roberto López, the Director of the Federal Medical-Biological Agency of Russia (FMBA), Dr. Vladimir Uiba and the Director of the St. Petersburg Institute for Scientific Research of Vaccines and Serums of the FMBA of Russia (IICVSSP) , Víctor Trukhín.
The MECHNIKOV Institute has reached a new stage of cooperation between Russia and Latin American countries which opens up unique opportunities to improve the level of sanitation throughout the region. The project was implemented in close collaboration with the support of the Pan American Health Organization (PAHO).
Vaccine production in Managua has been created in a record time. According to UNIDO, the complete cycle from the structural design of a plant of this type to the start-up in the conditions of developing countries can take up to 7 years. The construction of the industrial complex of the MECHNIKOV Institute was completed in less than a year, in October 2016.
It took more than two years to provide modern equipment, complete qualification procedures for critical engineering facilities and systems, validate technological processes in the framework of technology transfer, also validating the transportation of the finished product complying with the “cold chain” from Russia to Nicaragua and from Nicaragua to Cuba. In 2018, the certification process of compliance with the GMP requirements took place. It was carried out by the Cuban Regulatory Authority CECMED, which has a highest evaluation (level four) according to the PAHO scale.
Another equally important and complicated process for both time and resources consisted of registering the Russian influenza vaccine in Cuba and Nicaragua.
The largest producers of influenza vaccines are present in the markets of Latin American countries, including the French Sanofi Pasteur, the English GSK and the South Korean Green Cross, as well as local producers from Brazil, Mexico and Argentina.
Today, the MECHNIKOV Institute is the only biotechnology company in Central America and has the status of a regional producer.
Taking into account that the level of social support received by the population of Latin America is high, the public health sector of most of the countries in this region is interested in long-term cooperation, based on purchasing a sufficient quantity of pharmaceutical products at fixed prices. The MECHNIKOV Institute plans to market its products, including the influenza vaccine, at a competitive price based on the quantities supplied and the terms of the contracts that are signed.
From now on, it is planned to carry out the technology transfer of other immunobiological products on the MECHNIKOV Institute platform.
The Head of the FMBA of Russia, Dr. Vladimir Uiba points out that the development of the MECHNIKOV Institute will have three main lines. In the first place, it is a matter of producing the influenza vaccine and multiplying its commercial outlets. In addition, the MECHNIKOV Institute will guarantee the transfer of technology for the manufacture of relevant pharmaceutical products in the region, including the vaccine against hepatitis A and recombinant erythropoietin, produced by the State Institute for Scientific Research on Highly Purified Biopreparations. Another line of development will be the carrying out of research in the most diverse fields, as well as the preparation of human resources and the professional guidance of youth, in particular, within the framework of the BioNICA project..