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Assessment of stability of Live Plague vaccine Manufacturing and Basic Preparation Quality Indicators

https://doi.org/10.21055/0370-1069-2018-4-54-57

Abstract

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.

About the Authors

A. A. Zuenko
Stavropol Research Anti-Plague Institute
Russian Federation

Anastasia A. Zuenko.

13-15, Sovetskaya St., Stavropol, 355035.



N. V. Abzaeva
Stavropol Research Anti-Plague Institute
Russian Federation

13-15, Sovetskaya St., Stavropol, 355035.



S. E. Gostishcheva
Stavropol Research Anti-Plague Institute
Russian Federation

13-15, Sovetskaya St., Stavropol, 355035.



O. L. Startseva
Stavropol Research Anti-Plague Institute
Russian Federation

13-15, Sovetskaya St., Stavropol, 355035.



T. M. Gridina
Stavropol Research Anti-Plague Institute
Russian Federation

13-15, Sovetskaya St., Stavropol, 355035.



Yu. V. Bogdanova
Stavropol Research Anti-Plague Institute
Russian Federation

13-15, Sovetskaya St., Stavropol, 355035.



G. F. Ivanova
Stavropol Research Anti-Plague Institute
Russian Federation

13-15, Sovetskaya St., Stavropol, 355035.



D. V. Rostovtseva
Stavropol Research Anti-Plague Institute
Russian Federation

13-15, Sovetskaya St., Stavropol, 355035.



References

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Review

For citations:


Zuenko A.A., Abzaeva N.V., Gostishcheva S.E., Startseva O.L., Gridina T.M., Bogdanova Yu.V., Ivanova G.F., Rostovtseva D.V. Assessment of stability of Live Plague vaccine Manufacturing and Basic Preparation Quality Indicators. Problems of Particularly Dangerous Infections. 2018;(4):54-57. (In Russ.) https://doi.org/10.21055/0370-1069-2018-4-54-57

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ISSN 0370-1069 (Print)
ISSN 2658-719X (Online)