Live tularemia vaccine quality assessment according to test results under the mandatory certification
The results of the tests for the quality assessment of live tularemia vaccine under the Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation in 2011-2015 were analyzed in the present article. There wer...
| Main Authors: | , , , , , |
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| Format: | Article |
| Language: | Russian |
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Ministry of Health of the Russian Federation. Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products»
2018-02-01
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| Series: | Биопрепараты: Профилактика, диагностика, лечение |
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| Online Access: | https://www.biopreparations.ru/jour/article/view/72 |
| _version_ | 1797244597386084352 |
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| author | I. V. Kasina L. I. Raschepkin A. A. Goryaev S. A. Alekseeva T. I. Nemirovskaya A. A. Movsesyants |
| author_facet | I. V. Kasina L. I. Raschepkin A. A. Goryaev S. A. Alekseeva T. I. Nemirovskaya A. A. Movsesyants |
| author_sort | I. V. Kasina |
| collection | DOAJ |
| description | The results of the tests for the quality assessment of live tularemia vaccine under the Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation in 2011-2015 were analyzed in the present article. There were 14 batches (of 34) which did not comply with the requirements of regulatory documents (RD) in terms of «Specific activity (percentage of live microbial cells)», «Number of cutaneous doses» and «Thermal stability». The experimental results had confirmed the irregularity of tularemia vaccine batch samples in terms of «Specific activity (percentage of live microbial cells)» which, respectively, led to differences in vaccine samples in terms of the number of cutaneous and intradermal doses. It was confirmed that FT-agar is a nutrient providing all the necessary conditions for cultivating Francisella tularensis strain. Possible causes of irregular quality of the batches released in 2011 was considered in the present article. Test results for 93 batches of tularemia vaccine manufactured in 2012-2015 shown their full compliance with the requirements of RD. Consistent quality assurance of tularemia vaccine became the basis for the possibility of choice, certification and approval of new drug batches as industrial reference standards. |
| first_indexed | 2024-03-08T21:44:32Z |
| format | Article |
| id | doaj.art-e09f056c4d354f0db26581b3766a45d9 |
| institution | Directory Open Access Journal |
| issn | 2221-996X 2619-1156 |
| language | Russian |
| last_indexed | 2024-04-24T19:13:32Z |
| publishDate | 2018-02-01 |
| publisher | Ministry of Health of the Russian Federation. Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» |
| record_format | Article |
| series | Биопрепараты: Профилактика, диагностика, лечение |
| spelling | doaj.art-e09f056c4d354f0db26581b3766a45d92024-03-26T09:10:51ZrusMinistry of Health of the Russian Federation. Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products»Биопрепараты: Профилактика, диагностика, лечение2221-996X2619-11562018-02-0116425325972Live tularemia vaccine quality assessment according to test results under the mandatory certificationI. V. Kasina0L. I. Raschepkin1A. A. Goryaev2S. A. Alekseeva3T. I. Nemirovskaya4A. A. Movsesyants5Scientific Centre for Expert Evaluation of Medicinal ProductsFederal Government Healthcare Institution Medical Unit № 64 of the Federal Penitentiary ServiceScientific Centre for Expert Evaluation of Medicinal ProductsScientific Centre for Expert Evaluation of Medicinal ProductsScientific Centre for Expert Evaluation of Medicinal ProductsScientific Centre for Expert Evaluation of Medicinal ProductsThe results of the tests for the quality assessment of live tularemia vaccine under the Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation in 2011-2015 were analyzed in the present article. There were 14 batches (of 34) which did not comply with the requirements of regulatory documents (RD) in terms of «Specific activity (percentage of live microbial cells)», «Number of cutaneous doses» and «Thermal stability». The experimental results had confirmed the irregularity of tularemia vaccine batch samples in terms of «Specific activity (percentage of live microbial cells)» which, respectively, led to differences in vaccine samples in terms of the number of cutaneous and intradermal doses. It was confirmed that FT-agar is a nutrient providing all the necessary conditions for cultivating Francisella tularensis strain. Possible causes of irregular quality of the batches released in 2011 was considered in the present article. Test results for 93 batches of tularemia vaccine manufactured in 2012-2015 shown their full compliance with the requirements of RD. Consistent quality assurance of tularemia vaccine became the basis for the possibility of choice, certification and approval of new drug batches as industrial reference standards.https://www.biopreparations.ru/jour/article/view/72francisella tularensisвакцина туляремийная живаянормативная документацияспецифическая активностьпроцент живых микробных клетокконцентрация микробных клетокколичество накожных дозтермостабильностьколониеобразующая единицаотраслевой стандартный образецfrancisella tularensislive tularemia vaccineregulatory documentsspecific activitypercentage of live microbial cellsconcentration of microbial cellsnumber of cutaneous dosesthermal stabilitycolony forming unitgrowth media for cultivation and isolation of tularemia microbe (ft-agar)industry reference standard |
| spellingShingle | I. V. Kasina L. I. Raschepkin A. A. Goryaev S. A. Alekseeva T. I. Nemirovskaya A. A. Movsesyants Live tularemia vaccine quality assessment according to test results under the mandatory certification Биопрепараты: Профилактика, диагностика, лечение francisella tularensis вакцина туляремийная живая нормативная документация специфическая активность процент живых микробных клеток концентрация микробных клеток количество накожных доз термостабильность колониеобразующая единица отраслевой стандартный образец francisella tularensis live tularemia vaccine regulatory documents specific activity percentage of live microbial cells concentration of microbial cells number of cutaneous doses thermal stability colony forming unit growth media for cultivation and isolation of tularemia microbe (ft-agar) industry reference standard |
| title | Live tularemia vaccine quality assessment according to test results under the mandatory certification |
| title_full | Live tularemia vaccine quality assessment according to test results under the mandatory certification |
| title_fullStr | Live tularemia vaccine quality assessment according to test results under the mandatory certification |
| title_full_unstemmed | Live tularemia vaccine quality assessment according to test results under the mandatory certification |
| title_short | Live tularemia vaccine quality assessment according to test results under the mandatory certification |
| title_sort | live tularemia vaccine quality assessment according to test results under the mandatory certification |
| topic | francisella tularensis вакцина туляремийная живая нормативная документация специфическая активность процент живых микробных клеток концентрация микробных клеток количество накожных доз термостабильность колониеобразующая единица отраслевой стандартный образец francisella tularensis live tularemia vaccine regulatory documents specific activity percentage of live microbial cells concentration of microbial cells number of cutaneous doses thermal stability colony forming unit growth media for cultivation and isolation of tularemia microbe (ft-agar) industry reference standard |
| url | https://www.biopreparations.ru/jour/article/view/72 |
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