Development and study of the industrial reference standard for rubella vaccine activity

• Published in: Biopreparaty no. 3; pp. 49 - 53
• Main Authors: T. N. Yunasova, O. V. Fadeykina, E. S. Sidorenko, L. L. Sukhanova, O. Yu. Shitikova, K. A. Sarkisyan, T. N. Ilyasova, A. S. Binjatova, N. V. Tereshkina, O. B. Ustinnikova, R. A. Volkova, A. A. Movsesyants, D. V. Shvedov
• Format: Magazine Article
• Language: Russian
• Published: Ministry of Health of the Russian Federation. Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products 01.02.2018
• Subjects: branch reference standard; live rubella vaccine; the specific activity and stability; вакцина против краснухи; отраслевой стандартный образец; специфическая активность; стабильность; статистическая обработка; ускоренное старение, срок годности
• ISSN: 2221-996X; 2619-1156

Presents information on 1st series of branch standard sample to characterization the quality of the candidate of branch standard sample tested for performance evaluation: specific activity of authenticity, a description of sterility, presence of mycoplasma, loss on drying, pH, filling accuracy, the residual oxygen content in the vials. Attested feature of the new series of the standard sample is a specific activity, because the purpose of the of branch reference standard activity live Rubella vaccine is the suitability of the results of determining the specific activity of the Rubella virus in vaccines. Indicator specific activity of the candidate in the of branch reference standard was assessed by interlaboratory studies compared to current 1st standard sample of the enterprise and 1st International Reference Reagent For Rubella (Live) NIBSC-91/688. Certified value of the index is set «Specific activity of branch reference standard activity for rubella (4,63±0,50) lgCCE50/0,5 ml. Shelf-life stated by using test accelerated the degradation is not less than at minus 20°C.