Microgen Enhances the Tuberculosis Vaccines Production Control at the Gene Level

For the first time in Russia, the Scientific and Production Association Microgen of the Naсimbio holding (Rostec State Corporation) introduced the practice of the production control of tuberculosis vaccines at the level of analysis and comparison between the gene structures of mycobacteria strains of various years. Unique work was carried out by scientists of the branch office in Stavropol. The results are included in the International Gene Database and are available to scientists all over the world.

SPA Microgen has completed R&D on the comparative analysis of the genetic structure of the Mycobacterium bovis BCG-1 strain (Russia) from samples of the company's tuberculosis vaccine collected not only at the stages of industrial cultivation of strains within one production cycle, but also from 10 samples of products of various release years. The M. bovis BCG-1 strain (Russia) is a subtype of human strain of Mycobacteria bovis. According to research data, the sequences of the M. bovis BCG-1 strain in the Microgen vaccine samples, regardless of the cultivation stages of the strain and the year of the product manufacture, showed complete similarity. This indicates the stability not only of the strains used in production, but also of the entire production process of the company’s tuberculosis vaccines at the gene level.

Comprehensive work to confirm the stability of the strains used in the manufacture of BCG and BCG-M vaccines, and the stability of the production cycle of the company in Russia was carried out for the first time. Together with the previously developed bioluminescent method, which is tested in the Stavropol branch, such studies will significantly strengthen the quality control of finished products and the production process of domestic vaccines.

Data from unique Russian studies were included in the GenBank International Database under the number PRJNA386261. The worldwide database contains information about the sequences of DNA, RNA, and proteins encoded in them and today represents the “genetic history” of generations of more than 100,000 different organisms. Research data is available to scientists around the world.

Recall that in April of this year, Microgen also announced the introduction of the newest bioluminescent quality control method for tuberculosis vaccines in Russia, based on the technology for analyzing the amount of live TB bacilli in the product, which are detected using a special device, a bioluminometer. It measures the chemical energy of live Mycobacterium bovis, which is released in an oxidation reaction under the action of enzymes in the form of luminescence. This method allows to increase the accuracy and reduce the period of quality control of BCG vaccines from one month to 1.5 hours.