Биопрепараты: Профилактика, диагностика, лечение (Feb 2018)

Certification and shelf-life extension of a new batch of the branch reference standard for live tularemic vaccine's specific activity and immunogenicity

  • I. V. Kasina,
  • A. A. Goryaev,
  • L. I. Rashchepkin,
  • O. V. Fadeykina,
  • T. I. Nemirovskaya,
  • O. B. Ustinnikova,
  • O. A. Lobovikova,
  • S. A. Alekseeva,
  • R. A. Volkova,
  • A. A. Movsesyants

Journal volume & issue
Vol. 0, no. 4
pp. 32 – 38

Abstract

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The article presents the results obtained in the study of a new batch of a candidate branch reference standard for live tularemic vaccine (vaccine BRS). The candidate vaccine BRS was represented by a commercial batch of a product that met all applicable requirements of the manufacturer’s monograph (MM) for live tularemic vaccine’s quality attributes. The candidate vaccine BRS was certified for specific activity including a range of parameters, such as: microbial cells concentration, percentage of living microbial cells, dissociation degree (percent of SR (white) immunogenic colonies from the total number of colonies grown), as well as immunogenicity. Results of analysis that addressed the use of this batch of vaccine BRS and its quality attributes made it possible to extend the shelf-life of the product for 6 months.

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