Assessment of stability of Live Plague vaccine Manufacturing and Basic Preparation Quality Indicators
Objective of the study was to analyze the basic quality parameters of the produced live plague vaccine and stability of the preparation during the storage process. Materials and methods. Specifications for batch series of the live plague vaccine on the basis of Yersinia pestis EV NIIEG, manufactured...
| Main Authors: | , , , , , , , |
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| Format: | Article |
| Language: | Russian |
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Federal Government Health Institution, Russian Research Anti-Plague Institute “Microbe”
2018-12-01
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| Series: | Проблемы особо опасных инфекций |
| Subjects: | |
| Online Access: | https://journal.microbe.ru/jour/article/view/1088 |
| _version_ | 1826922343347257344 |
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| author | A. A. Zuenko N. V. Abzaeva S. E. Gostishcheva O. L. Startseva T. M. Gridina Yu. V. Bogdanova G. F. Ivanova D. V. Rostovtseva |
| author_facet | A. A. Zuenko N. V. Abzaeva S. E. Gostishcheva O. L. Startseva T. M. Gridina Yu. V. Bogdanova G. F. Ivanova D. V. Rostovtseva |
| author_sort | A. A. Zuenko |
| collection | DOAJ |
| description | Objective of the study was to analyze the basic quality parameters of the produced live plague vaccine and stability of the preparation during the storage process. Materials and methods. Specifications for batch series of the live plague vaccine on the basis of Yersinia pestis EV NIIEG, manufactured between 2012 and 2017, in compliance with the regulations of the normative documentation were assessed. The parameters under investigation were: viability, thermal resistance, absence of extraneous substances and fungi, weight loss in the process of drying, immunogenicity. Results and conclusions. Comparative analysis of the vaccine viability (quantity of live microbe cells) in the batches manufactured over the past 6 years was carried out. All the studied vaccine series have the appropriate indicators stated in the Specification to the Pharmacopeia Monograph and master formula which testifies to the stability of manufacturing line and basic live plague vaccine quality parameters throughout the whole term of storage. It is outlined that the production of the vaccine, corresponding to the requirements of the normative regulations, depends upon the strict adherence to the rules by the personnel, usage of high-grade stock and materials, validation of equipment and technological processes of manufacturing. |
| first_indexed | 2024-03-08T13:42:58Z |
| format | Article |
| id | doaj.art-e471938f5f16454f9f832219209872b7 |
| institution | Directory Open Access Journal |
| issn | 0370-1069 2658-719X |
| language | Russian |
| last_indexed | 2025-02-17T14:08:26Z |
| publishDate | 2018-12-01 |
| publisher | Federal Government Health Institution, Russian Research Anti-Plague Institute “Microbe” |
| record_format | Article |
| series | Проблемы особо опасных инфекций |
| spelling | doaj.art-e471938f5f16454f9f832219209872b72024-12-24T12:09:54ZrusFederal Government Health Institution, Russian Research Anti-Plague Institute “Microbe”Проблемы особо опасных инфекций0370-10692658-719X2018-12-0104545710.21055/0370-1069-2018-4-54-571071Assessment of stability of Live Plague vaccine Manufacturing and Basic Preparation Quality IndicatorsA. A. Zuenko0N. V. Abzaeva1S. E. Gostishcheva2O. L. Startseva3T. M. Gridina4Yu. V. Bogdanova5G. F. Ivanova6D. V. Rostovtseva7Stavropol Research Anti-Plague InstituteStavropol Research Anti-Plague InstituteStavropol Research Anti-Plague InstituteStavropol Research Anti-Plague InstituteStavropol Research Anti-Plague InstituteStavropol Research Anti-Plague InstituteStavropol Research Anti-Plague InstituteStavropol Research Anti-Plague InstituteObjective of the study was to analyze the basic quality parameters of the produced live plague vaccine and stability of the preparation during the storage process. Materials and methods. Specifications for batch series of the live plague vaccine on the basis of Yersinia pestis EV NIIEG, manufactured between 2012 and 2017, in compliance with the regulations of the normative documentation were assessed. The parameters under investigation were: viability, thermal resistance, absence of extraneous substances and fungi, weight loss in the process of drying, immunogenicity. Results and conclusions. Comparative analysis of the vaccine viability (quantity of live microbe cells) in the batches manufactured over the past 6 years was carried out. All the studied vaccine series have the appropriate indicators stated in the Specification to the Pharmacopeia Monograph and master formula which testifies to the stability of manufacturing line and basic live plague vaccine quality parameters throughout the whole term of storage. It is outlined that the production of the vaccine, corresponding to the requirements of the normative regulations, depends upon the strict adherence to the rules by the personnel, usage of high-grade stock and materials, validation of equipment and technological processes of manufacturing.https://journal.microbe.ru/jour/article/view/1088live plague vaccinelivabilityshelf lifestabilitypreparation quality |
| spellingShingle | A. A. Zuenko N. V. Abzaeva S. E. Gostishcheva O. L. Startseva T. M. Gridina Yu. V. Bogdanova G. F. Ivanova D. V. Rostovtseva Assessment of stability of Live Plague vaccine Manufacturing and Basic Preparation Quality Indicators Проблемы особо опасных инфекций live plague vaccine livability shelf life stability preparation quality |
| title | Assessment of stability of Live Plague vaccine Manufacturing and Basic Preparation Quality Indicators |
| title_full | Assessment of stability of Live Plague vaccine Manufacturing and Basic Preparation Quality Indicators |
| title_fullStr | Assessment of stability of Live Plague vaccine Manufacturing and Basic Preparation Quality Indicators |
| title_full_unstemmed | Assessment of stability of Live Plague vaccine Manufacturing and Basic Preparation Quality Indicators |
| title_short | Assessment of stability of Live Plague vaccine Manufacturing and Basic Preparation Quality Indicators |
| title_sort | assessment of stability of live plague vaccine manufacturing and basic preparation quality indicators |
| topic | live plague vaccine livability shelf life stability preparation quality |
| url | https://journal.microbe.ru/jour/article/view/1088 |
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