For the first time in Russia the Scientific and Production Association “Microgen”, a part of Nacimbio holding company, has implemented the control over the manufacturing of TB vaccines involving the analysis and comparison of the genome structure of mycobacterium strains used in the production process in different years. The unique works were performed by the researchers at the branch of the Association in the city of Stavropol. The results have been included in the international bank of genetic data and are available to scientists around the world.
NPO Microgen has completed the research on comparative analysis of the genetic structure of Mycobacterium bovis BCG-1 (Russia) strain taken from the samples of TB vaccine manufactured by the company and collected not only at the stages of serial cultivation of strains within a single manufacturing cycle, but also from 10 samples of drugs produced in different years. M. bovis BCG-1 (Russia) strain is a sub-type of Mycobacteria bovis strain, which is safe for humans. According to the study results, the gene sequences of M. bovis BCG-1 strain found in the samples of Microgen vaccines showed complete similarity regardless of the stages of strain cultivation or the year of drug manufacture. This indicates the stability of not only the strains used in the manufacturing, but also the stability of entire production process of TB vaccines in the enterprise at the gene level.
The results of the unique Russian study were included in the international GenBank database under the number PRJNA386261.