Microgen Introduces Technology to Accelerate the Quality Control of Tuberculosis Vaccines
The up-to-date Russian method will reduce the period of the quality control of BCG vaccines from one month to 1.5 hours. The technology has been developed and is being tested on the basis of the Stavropol branch of SPA Microgen, which is part of the National Immunobiological Company, Rostec State Corporation. The method will increase the volume and speed of production of BCG and BCG-M vaccines.
According to the World Health Organization, BCG is the only tuberculosis vaccine that protects against tuberculous meningitis and disseminated tuberculosis in infants and young children. Over the years, vaccination has saved thousands of lives. The vaccine contains live vaccine strains and is available in two versions: BCG and pediatric BCG-M for attenuated primary immunization.
One of the key steps in the quality control of a vaccine is the analysis of the amount of live Tubercle bacilli in the product. Only viable bacteria determine the activity of the formation of the body defense reaction. The developed method will make it possible to drastically reduce the duration of control measures and further increase the volumes of products released.
The new technology is launched in Russia on the basis of the Stavropol branch of SPA Microgen. The technology is based on bioluminescent analysis of the amount of live Tubercle bacilli in the product, which are detected using a special device, a bioluminometer. It allows to measure the chemical energy of live Mycobacterium bovis, which is released in an oxidation reaction under the action of enzymes in the form of luminescence.