Inauguration of new Hepatitis B vaccine manufacturing plant in Moscow in a Russian/Belgian joint venture
The manufacturing plant 'SB-Biomed' is the result of a joint venture between GlaxoSmithKline (GSK) and local Russian partners Biomed and Immunogen. The joint venture underscores GSK's commitment to Russia.
The plant's activities include the filling of vaccine ampoules, labelling, packaging and the performance of quality controls on Engerix B (GSK's recombinant hepatitis B vaccine) destined for the Russian market. The plant has an annual filling capacity of four million ampoules and a packaging capacity of up to nine million doses of Engerix B.
Speaking at the official inauguration, Mr Viehbacher said: "There are an estimated five million hepatitis B carriers in Russia today. Over 70 per cent of these are in the 15 to 29 age group. The vaccine we will manufacture here will go along way to containing the hepatitis epidemic in Russia.
"This joint-venture is a true partnership involving the transfer of technology from our GSK Biologicals vaccines operations plant in Belgium to our partners here in Russia. SB-Biomed is a modern Russian production plant, featuring the latest technologies and world-class quality control, in line with the highest world standards."
The project involved the transfer of Belgian technologies for design, construction and validation of the plant and the training of Russian personnel and management of the unit, including Quality Assurance and Quality Control. The plant is divided into two main departments: Production and Quality Control and Quality Assurance. It will operate to world class Good Manufacturing Practice (GMP) standards.
GlaxoSmithKline Biologicals in Rixensart, Belgium, produces the final bulk Engerix B vaccine which is shipped to Russia through a complex and tightly controlled refrigeration chain, before being filled in ampoules in a strictly controlled sterile process at the Russian plant. The vaccines are then labelled and packed and samples sent to the Russian State control organisation for quality testing and to obtain approval for commercialisation.
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