Nanolek plans to launch the full-cycle production of a 5-in-1 infant vaccine under a technology transfer project with Sanofi Pasteur (France) by 2022.
The first phase in the project to localize the production of the vaccine in Russia and the transfer of quality control standards were completed in 2016, Nanolek’s press service informed Interfax.
The year 2018 marked the beginning of the second phase in the transfer of technology and quality control standards – the production of finished dosage forms. By 2022, the localization project is to be completed. The annual production capacity is projected at 8 million – 10 million doses.
Five million doses of the pentavalent vaccine have been put out at the Nanolek plant in the Kirov region since the project got started. In 2017, the company began shipping the locally packaged vaccine in compliance with the national vaccination schedule. Over 3 million doses were shipped in 2017-18.
Sanofi Pasteur and Nanolek signed a cooperation agreement in 2015 to localize the production of the pentavalent vaccine in Russia. The vaccine is made at Nanolek’s production facility in the town of Levintsy of the Kirov region under the import substitution program in the pharmaceutical industry.
The pentavalent vaccine protects against Haemophilus influenza type B, a bacterium that causes meningitis, pneumonia and otitis, and against whooping cough, tetanus, Hepatitis B and diphtheria, and is applied during the first two years of an infant’s life. The vaccine has been used in Russia since 2008. The vaccine’s production is a step-by-step process lasting for 24 to 32 months. The production of tablets normally lasts for just about three weeks. Seventy percent of the time is spent on quality control.
Nanolek LLC is a Russian biopharmaceutical company manufacturing import-substituting and innovative pharmaceutical products independently or with foreign partners’ assistance. It is controlled by Vladimir Khristenko, former industry and trade minister Viktor Khristenko’s son, and by General Director Mikhail Nekrasov. The company is also co-owned by Rusnano.
Pasteur, Sanofi’s division, is one of the world’s leading developers of human vaccines. The company’s vaccines protect against 15 viral and bacterial diseases. Pasteur annually puts out more than 1 billion vaccine doses to immunize over 500 million people globally.