Procedure for preparation, certification, and storage of a seed lot of the <i>Mycobacterium bovis</i> BCG-I (Russia) vaccine strain

Procedure for preparation, certification, and storage of a seed lot of the <i>Mycobacterium bovis</i> BCG-I (Russia) vaccine strain

To date, the Bacillus Calmette–Guérin (BCG) vaccine has been the only medicinal product for active mass childhood immunisation against tuberculosis in the Russian Federation. Industrial-scale batches of the BCG vaccine are manufactured using a seed-lot system, which provides for producing the vaccin...

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Bibliographic Details
Main Authors: D. T. Levi, R. I. Ludannyy, Yu. I. Obukhov, A. A. Savina, A. A. Alesina, N. V. Aleksandrova
Format: Article
Language:Russian
Published: Ministry of Health of the Russian Federation. Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» 2022-10-01
Series:Биопрепараты: Профилактика, диагностика, лечение
Subjects:
bcg vaccine
seed lot
substrain
seed-lot system
genome stability
Online Access:https://www.biopreparations.ru/jour/article/view/455
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