The event was held as part of the All-Russian GMP conference. Elena Ryskova, the head of the Influenza Products Department, shared her experience in the production of immunobiological medications using the influenza vaccines as the case study. “…influenza vaccine is remarkable for its seasonality; manufacturers should bear that in mind and arrange robust planning and quality control systems at their enterprises.”
The panelists discussed the progress in the development of immunobiological drugs on the Russian pharmaceutical market. In recent years, this topic has been prioritized at the highest level. Currently, on the instructions of the President of the Russian Federation, work is underway to approve the Strategy for Immunization Against Infectious Diseases for the period up to 2035. The top-priority tasks of the Strategy are to satisfy the needs of the population in immunobiological products by 2025 and to leverage domestic enterprises to launch the full production cycle of vaccines included in the National Preventive Vaccination Calendar and the Calendar of Preventive Vaccinations for Epidemic Indications.
The panelists also discussed the subject of entering the Latin American market and the specifics of passing the inspectorate assessment. Dr. Rafael Perez, who passed away in 2020, was remembered for his contribution to the development of the pharmaceutical market in the region as the head of CECMED, a major regulatory body. Stanislav Uiba, Director of Instituto Latinoamericano de Biotecnología MECHNIKOV (production site of SPbSRIVS in Nicaragua) shared the highlights of the implementation of an important Russian-Nicaraguan project, the construction of the only biotechnological enterprise in Central America, and the inspectorate assessment: “The construction of the plant was financed jointly by the governments of Russia and Nicaragua, and the facility began operations in April 2019. CECMED, as a major regulator in Latin America, assessed the compliance of Instituto MECHNIKOV with Good Manufacturing Practice (GMP) standards.
The technology transfer for the production of influenza vaccine was provided by the Saint Petersburg Scientific Research Institute of Vaccines and Serums. Dr. Peres delivered a speech at the 80th anniversary of SPbSRIVS and highly appreciated the contribution of the Russian specialists to the new production facility.” Read more about the event in the article “GMP News”:
https://clck.ru/RMBMm https://clck.ru/RMBQi
