M. BOVIS BCG-1 (RUSSIA) SUB-STRAIN GENOME STABILITY INVESTIGATION WITHIN THE ENTIRE PRODUCTION PROCESS

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Aim. The aim of the current study was to analyze the genome structure of the M. bovis BCG-1 (Russia) sub-strain, used for the vaccine production, as well as its genome stability within the entire production process. Materials and methods. Whole genome sequencing and M. bovis BCG-1 (Russia) working seed lot and for the last production passage of the sub-strain cultivation from a number of the vaccine batches. Additionally, VNTR sequences of 24 locus analyses, RD patterns comparison, as well as spoligotyping were performed. Results. The whole genome sequence of the M. bovis BCG-1 (Russia) working seed lot was assembled, annotated and deposited to GenBank. On the basis of DU2- and RD-regions analyzes M. bovis BCG-1 (Russia) sub-strain was confirmed to be belonged to BCG Russia strains of DU2-I group. Whole genome sequencing followed by comparative analysis of RD patterns and SNPs confirmed the stability of the vaccine sub-strain genome from the working seed lot to a number of the vaccine batches obtained within the two-years period. VNTR profile and spoligopattern exactly matched the M. bovis BCG-1 (Russia). Conclusion. Thus the M. bovis BCG-1 (Russia) sub-strain genome identity and stability have been studied and demonstrated. The obtained result confirmed the vaccine production process consistency.

About the authors

E. V. Otrashevskaya

Scientific and Production Association for Immunobiological Preparations «Microgen»

Author for correspondence.
Email: noemail@neicon.ru
Россия

V. N. Vinokurova

Scientific and Production Association for Immunobiological Preparations «Microgen»

Email: noemail@neicon.ru
Россия

E. A. Shilikov

Federal Scientific and Clinical Centre of Phusical-Chemical Medicine

Email: noemail@neicon.ru
Россия

E. A. Sotnikova

Federal Scientific and Clinical Centre of Phusical-Chemical Medicine

Email: noemail@neicon.ru
Россия

T. A. Perevyshina

Scientific and Production Association for Immunobiological Preparations «Microgen»

Email: noemail@neicon.ru
Россия

S. A. Kolchenko

Federal Scientific and Clinical Centre of Phusical-Chemical Medicine

Email: noemail@neicon.ru
Россия

T. B. Butusova

Federal Scientific and Clinical Centre of Phusical-Chemical Medicine

Email: noemail@neicon.ru
Россия

E. S. Kostryukova

Federal Scientific and Clinical Centre of Phusical-Chemical Medicine

Email: noemail@neicon.ru
Россия

E. N. Ilina

Federal Scientific and Clinical Centre of Phusical-Chemical Medicine

Email: noemail@neicon.ru
Россия

G. M. Ignalev

Scientific and Production Association for Immunobiological Preparations «Microgen»; St. Petersburg Research Institute of Vaccines and Sera and the Bacterial Preparations Factory

Email: noemail@neicon.ru
Россия

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Copyright (c) 2018 Otrashevskaya E.V., Vinokurova V.N., Shilikov E.A., Sotnikova E.A., Perevyshina T.A., Kolchenko S.A., Butusova T.B., Kostryukova E.S., Ilina E.N., Ignalev G.M.

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