NGO Microgen developed a manufacturing process for type A and C meningococcal vaccine
A pharmaceutical manufacturer Immunopreparat, NGO Microgen branch in Ufa, developed a manufacturing process for bivalent polysaccharide meningococcal vaccine type A and C. Experimental batches of the novel drug product intended to protect adults and children from meningococcal infection are currently undergoing pre-clinical trials.
According to the manufacturer, the studies of acute and chronic toxicity and immunogenicity of the produced were completed in late 2014, and the new vaccine was proven safe. The next step included clinical trials of the vaccine to assess its reactogenicity, safety and immunogenicity.
Development and introduction of a novel vaccine were made possible due to cooperation of Ufa branch of NGO Microgen with Gabrichevsky bacterial products enterprise in Moscow.
As part of this work, for the first time Immunopreparat approved and introduced a controlled reactor method of cultivating the group A and C strains of meningococcal vaccine; composition of the nutrient medium also was optimized. As a result of the modernization of manufacturing, efficiency has increased by 50%, and the complexity of the process has significantly reduced.
Clinical studies of group A meningococcal vaccine produced by modified method showed its full compliance with the requirements of World Health Organization (WHO). 4400 packages of monovalent vaccine were produced in 2014. In 2015, a plan of production was increased by 3.5.
According to WHO, infectious disease caused by the Neisseria meningitidis, is characterized by high mortality and serious complications. Its' incidence in developed countries is 1-3 cases per 100 000 annually; in developing countries during the outbreaks this figure rises up to 100.
When antibiotic treatment, the mortality reaches 10% of cases, and 5 - 20% of patients experience significant neurological effects of the disease. The problem of an effective vaccine prevention of meningococcal disease remains relevant. Polysaccharide vaccines used for the prevention of severe illness are considered safe and have a high level of immunogenicity.
The new vaccine will be made in the multicomponent vaccine plant reconstructed according to modern standards and equipped with modern high-tech equipment produced in Russia and abroad.