Identity and stability assessment of BCG vaccine by multiplex PCR

• Main Authors: D. T. Levi, Yu. I. Obukhov, N. V. Aleksandrova, R. A. Volkova, E. V. Elbert, M. V. Alvarez Figeroa, A. V. Prokopenko, R. I. Ludanniy
• Format: Article
• Language: Russian
• Published: Ministry of Health of the Russian Federation. Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» 2018-02-01
• Series: Биопрепараты: Профилактика, диагностика, лечение
• Subjects: посевная серия; мультиплексная полимеразная реакция; субштаммы бцж; стабильнось; подлинность; seed lot; multiplex polymerase reaction; bcg substrains; stability; identity
• Online Access: https://www.biopreparations.ru/jour/article/view/41

Multiplex polymerase chain reaction method was used to assess the stability of 7 seed lots of a substrain Mycobacterium bovis BCG-1, Russia, used for the manufacture of BCG vaccine since 1948 till present. For performng PCR we used primers, matching 5 parts of the RD field and 1part of repeating elements of intergenic operon senX3-regX3 region. Electrophoregrams of amplification products for 7 seed lots of products were identical and differed from the electrophoregrams of other known BCG substrains used as control samples. Similar results were obtained for genotyping of 32 commercial lots of BCG vaccine, manufactured using substrain M. bovis BCG-1 by three Russian manufacturers. The obtained data confirmed the stability of seed lots of BCG vaccine used for more than 60 years, and the adequacy of the settled system of strain maintanance. The assessed method of multiplex PCR with domestic reagents can accepted for confirming that the seed and the vaccine are identical to domestic BCG vaccine substrain (M. bovis BCG-1) when performing «Identification» test. The mehod is adequate and reproducible.