GENERIUM launched the production of Sputnik V vaccine

Moscow, 26 October 2020. The Ministry of Health of the Russian Federation has included a biotechnology company GENERIUM in the marketing authorisation as a manufacturer of Gam-COVID-Vac (Sputnik V) vaccine for the prevention of COVID-19.

The Sputnik V vaccine was developed by the Federal State Budgetary Institution N.F. Gamaleya Federal Research Centre for Epidemiology and Microbiology of the Ministry of Health of the Russian Federation and became world's first registered vaccine for the prevention of coronavirus infection COVID-19.

Scaling-up of the vaccine production technology at the GENERIUM manufacturing site was performed with the use of modern process approaches and advanced equipment. A wide team of GENERIUM specialists with many years of experience in the development and production of biotechnological medicinal products is involved in this project.

'Today, all efforts of the world community are aimed at developing a vaccine against the novel coronavirus. In pandemic conditions, Russian manufacturers and scientists went to the forefront of the fight against the virus, ensured the uninterrupted work of production facilities and did not stop the development of new medicinal products. The competence of Generium made it possible to implement such complicated project as scaling up the production of a novel, world's first vaccine against coronavirus in a short time. As soon as it reaches full capacity, the Company's site will be able to produce 60 to 100 million doses of vaccine per year. I would like to note that to expand its production competencies, the Company actively uses the toolkit of government support measures. Thus, with concessional loans from the Industrial Development Fund, Generium will organise the production of express test kits for detecting coronavirus, expands the production of medicinal products for the treatment of hereditary diseases and asthma. The company is one of the key implementers of the federal program PharmaMed-2020. It has rich expertise in scaling-up of laboratory technologies, complies with international standards of Good Manufacturing Practice (GMP); it also possesses the most advanced equipment and profound scientific base. The combination of all these factors and the well-coordinated work of the manufacturer, developer and regulators allowed us to enter an important stage in the fight against the COVID-19 pandemic',Denis Manturov, Minister of Industry and Trade of Russia said.

Mikhail Murashko, Minister of Health of the Russian Federation, 'Today we have added the Generium manufacturing site to the marketing authorisation of the Gam-COVID-Vac or Sputnik V vaccine. The manufacturer has successfully implemented the technologies for the development of Sputnik V vaccine for the prevention of novel coronavirus infection. This is the most modern production that complies with the GMP standards and ensures high quality of the medicinal product. The first batches of vaccines are already undergoing release control before commercialisation. With the start of production at Generium manufacturing site, we begin practical implementation of the plan of scaling up the production of the first COVID-19 vaccine'.

Daniil Taliansky, Board Member of GENERIUM,'Thanks to our joint work with the Ministry of Health of the Russian Federation, the Ministry of Industry and Trade of Russia and the Federal State Budgetary Institution N.F. Gamaleya Federal Research Centre for Epidemiology and Microbiology, GENERIUM has successfully completed the transfer and scaling up of the Gam-COVID-Vac vaccine production technology at its research and production base. For today, it is the first completed transfer of the full production cycle: from the substance to the finished form of the vaccine. Today, more than 90 thousand doses have been produced, and we expect that the first batch of the vaccine will reach the country's medical and preventive treatment facilities by the end of October. Now we are working on a step-by-step escalation of production capacity, reaching indicators from 5 to 8 million doses per month'.

Alexander Gintsburg, member of the Russian Academy of Sciences, Director of the Federal State Budgetary Institution N.F. Gamaleya Federal Research Centre for Epidemiology and Microbiology of the Ministry of Health of the Russian Federation, 'During our cooperation, we were able to highly appreciate the competence of the GENERIUM employees and build a system for their effective interaction with our employees and become a single team. This enabled to implement the transfer of our technology to the GENERIUM manufacturing site in such a short time and, thereby, accelerate the access of citizens of the Russian Federation to the vaccine. The speed and accuracy of their decisions when transferring the technology of the Centre to their site speaks of the highest competence of scientists and process engineers involved in the project. Transfer and reproduction of technology is a labour-intensive process that requires deep knowledge, scientific and expert approach and flexibility. We are sure that thanks to the launch of production at the GENERIUM site, the Russian healthcare system will gain wider access to the vaccine that everyone needs'.

About the company:

GENERIUM is a biotechnology company, the leader in the Russian pharmaceutical market for orphan diseases. The Company possesses its own R&D park, which is capable of developing any biotech product, from molecule design to commercial production. GENERIUM's manufacturing facilities are organised in strict compliance with international GMP standards. The Company's plants produce a unique variety of biotech products and are capable of manufacturing any kind of biomedical cell products.


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