Stability Study of Rev1 Reduced dose Brucellosis Vaccine Produced by Razi Institute in Iran

Document Type : Full Research Paper

Authors

1 Dept. of Bacterial Vaccines Quality Control, Razi Vaccine & Serum Research Institute, Agricultural Research, Education and Extension Organization (AREEO), Tehran, Iran

2 Dept. of Bacterial Vaccines Quality Control, Razi Vaccine & Serum Research Institute, Agricultural Research, Education and Extension Organization (AREEO), Tehran, Iran;

3 Dept. of Brucella Vaccine Production, Razi Vaccine & Serum Research Institute, Agricultural Research, Education and Extension Organization (AREEO), Tehran, Iran

4 Dept. of Brucella Vaccine Production, Razi Vaccine & Serum Research Institute, Agricultural Research, Education and Extension Organization (AREEO), Tehran, Iran;

5 Dept. of Physicochemistry, Razi Vaccine & Serum Research Institute, Agricultural Research, Education and Extension Organization (AREEO), Tehran, Iran

Abstract

Stability study of biological products plays an important role for determination of product changes in maintenance period and ensuring of safety and efficacy of vaccines. In this study longterm stability reduced-dose Rev.1 strain brucellosis vaccin that manufactured by Razi vaccine and serum research institute was evaluated. Sampling was conducted in accordance with references OIE 2015, and the samples after storage at 8-2 ° C and packaging conditions for 11 months, according to the vaccine package insert an interval of one month was tested for stability Real time. In this study, all tests quality control and physicochemical tests for evaluate the stability the vaccine for every 3 batches to 11 months after production was performed.For analyzing information from median, mean, variance, correlation and linear regression were used. The results of the study showed that all batches of studied, stable for 10 months in accordance with the requirements OIE 2015. If the conditions that all the requirements related to the preservation of vaccine including cold chain conditions should be observed. The vaccine can be stable for 10 months. Therefore, in accordance with the requirements OIE 2015, BP 2015 the expiration date of the vaccine can be increased from 4 months to 7 months.

Keywords

References


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Veterinary Research & Biological Products
Volume 30, Issue 3 - Serial Number 116
September 2017
Pages 26-33

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History

  • Receive Date: 30 August 2016
  • Revise Date: 25 October 2016
  • Accept Date: 31 October 2016

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