The first day of FEISP 2019 was highlighted by the Russian-Nicaraguan meeting at the government level.
The parties signed a Memorandum of Cooperation in various fields between the Russian Federation and the Republic of Nicaragua. The signing of the Memorandum was preceded by a rich history of interaction between the countries. Russia and Nicaragua are united by cooperation in various areas. In particular, the production of vaccines for Latin American countries under the close supervision of specialists from the Latin American Institute of Biotechnology Mechnikov.
On March 29, 2019, the management of Ethiopia’s largest pharmaceutical factory, Addis Pharmaceutical Factory, visited the production site of the Latin American Institute of Biotechnology MECHNIKOV (Managua, Nicaragua).
The unique technological solutions used in the construction of the plant were presented to the Ethiopian guests by specialists from the Fabtech company, who acted as general contractors in the construction of the laboratories and production sites of the MECHNIKOV Institute.
In the framework of the visit, the parties exchanged their experiences, particularly in the areas of turnkey construction and equipping of biotechnology industry factories.
The representatives of Addis Pharmaceutical Factory praised the production complex of the MECHNIKOV Institute and expressed interest in cooperation. The specialists from the MECHNIKOV Institute confirmed their willingness to participate in the necessary consultations with Ethiopian colleagues on the management of a project of the same magnitude.
About Addis Pharmaceutical Factory (apfethio.com).
The largest pharmaceutical manufacturing company headquartered in Ethiopia. The company produces more than 91 pharmaceutical products. The company’s production processes comply with the GMP standards of the local regulatory authority, the Food, Drug and Health Administration in Ethiopia.
About Fabtech (fabtechnologies.com).
A global leader in turnkey engineering solutions for pharmaceutical, biotech and medical companies around the world. The company is already trusted by more than 1,000 clients in 53 countries.
On March 27, Instituto Latinoamericano de Biotecnología MECHNIKOV received the BPM ( Good Manufacturing Practices in English) certification for the manufacturing process of the Fractionated Inactivated Influenza Vaccine indicated for the prevention of influenza. This is an important achievement for the Institute because it consolidates its leadership in the area of the production of Biological products in Central and Latin America.
This new GMP certification allows the MECHNIKOV Institute to expand its offer of services to third parties regarding the production and release of biological products .
This milestone has demonstrated the ability of the MECHNIKOV Institute to certify BPM of the production process, the first of its type, born of a project of Technology Transfer of the Institute of St. Petersburg vaccines. This has been possible thanks to the close collaboration and trust between the Pan American Health Organization (PAHO), the Ministry of Health of the Republic of Nicaragua, the Center for the Control State of Medicines, Equipment and Devices of the Republic of Cuba (CECMED).
MECHNIKOV Institute is a pioneer in the production of products Biologics in Central America, and is also involved in other technology transfer projects for treatment and prevention of other pathologies.
MECHNIKOV Institute has the know-how necessary to face manufacturing projects for third parties of biological products.
With this certification, the MECHNIKOV Institute is in a position to comply with international regulations to guarantee the quality, safety and efficacy of the Flu Vaccine.
From January 14 to January 18, 2019, experts from the Cuban regulatory authority CECMED have been conducting the final GMP audit.
It should be remembered that the final audit was preceded by intense work carried out by specialists from the MECHNIKOV Institute in December.
Thus, from December 3 to 7, 2018, the MFT (Media Fill Test [esp. Media Fill Test]) was bottled. It is a test of the simulation of the filling of the vials that represents a critical stage in the control and validation of aseptic processes to confirm the sterility of the production facilities. During the three-series MFT, the sterility and microbiological purity of the filling process has been demonstrated.
After filling, samples were taken from the primary container to carry out their control. The results obtained from December 17 to 21, 2018 determined the absence of endotoxins and the microbiological purity (sterility) of the samples from the three MFT series.
Similarly, from December 16 to 18, 2018, a validation series of the vaccine for the prevention of influenza was completed (<em> in bulk </em>, the vaccine was previously delivered by the IICVSSP). The results of the quality control of the filling of the validation series that we obtained in early January 2019 determined the absence of endotoxins and the microbiological purity (sterility).
On April 11, Managua, the Latin American Institute of Biotechnology MECHNIKOV received high-level guests from the Russian Ministry of Health, the Nicaraguan Institute of Social Security (INSS), the Federal Medico-Biological Agency of Russia, CECMED and WHO / PAHO. The reason for the visit was the meeting of the Russian-Nicaraguan Technical Advisory Committee.
This meeting was highlighted by the senior participants. The Vice Minister of Health of Russia Dr. Sergey Kraevoy and Head of the Federal Medical-Biological Agency of Russia Dr. Vladimir Uiba arrived in Nicaragua. On the part of the Institute of vaccines and serums participated Director of IICVSSP Dr. Victor Trukhin, Deputy Director of IICVSSP Dr. Anatoly Evtushenko. “To a large extent, this Technical Committee is also distinguished because the representatives of the Russian regulator took part in the meeting: Dr. Vadim Merkulov of the Scientific Center that performs examinations of medicines of the Ministry of Health, Dr. Vladislav Shestakov of the State Institute of Medicines and Good practices. It is very important and useful for the more dynamic and sustainable development of the MECHNIKOV project in the region ”- stated Dr. Stanislav Uiba – General Manager of the Latin American Institute of Biotechnology MECHNIKOV.
The Committee monitors the current status and progress of technology transfer for the production of immunobiological and biological preparations from the Russian Federation to the Republic of Nicaragua. The delegates positively evaluated the current state, confirmed the fulfillment of the previously announced plan for the realization of the MECHNIKOV project. Also during the Committee meeting they discussed the use of the MECHNIKOV production plant as the additional center for professional practice and recruitment of specialists. At the moment, in the field of preparing the IICVSSP personnel reserve, jointly with UNAN-MANAGUA and MECHNIKOV specialists are carrying out the pilot project of a training camp for adolescents.
The tour of the plant
The MECHNIKOV production plant
During the Committee, the delegates visited the production plant of the Latin American Institute of Biotechnology MECHNIKOV, where they learned about the process of filling and packaging the influenza vaccine. After the excursion to the plant, Deputy Minister of Health of Russia Dr. Sergey Kraevoy said: “This plant can produce up to 30 million doses of vaccine annually”, in the future it is planned to expand the line of drugs. In her turn, Dr. Socorro Gross Galiano – WHO / PAHO Representative in Nicaragua – drew the audience’s attention to the great potential of MECHNIKOV: “We consider that it is a very important project, and that it is also oriented on what they say. the sustainable development objectives, which is access to universal coverage of quality vaccines and medicines ”.
“This project is important not only for Nicaragua, but for the entire region … Nicaragua is the first country in Central America, which will have its own production of high quality vaccines” – added Dr. Gross Galiano.
About the Russian-Nicaraguan Technical Advisory Committee
In February 2015, during the negotiations in Managua, Republic of Nicaragua, a Technical Advisory Committee was formed on the issues of technology transfer in the Health sphere. The Committee consists of representatives of interested institutions from both countries, as well as representatives of WHO / PAHO and CECMED as a regional regulatory body, added by PAHO.