Stability Study of Iriba Brucellosis Full-dose and Reduced-dose Vaccine Produced by Razi Institute in Iran

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 research, accelerated and long-term stability study performed for six batches of full and reduced-dose cattle Iriba strain brucellosis vaccine that manufactured by Razi vaccine and serum research institute as a new vaccine. After sampling, the vaccines were tested for accelerated stability, after four days storage at ۲۲ ۰C and tested intervals in three months until ۲۴ months for long-term stability after storage at ۲-۸ ۰C. The result indicated all batches of vaccines in accelerated stability met the specification recommended by OIE ۲۰۱۲ and the mean loss of activity for full-dose was ۱۶.۶۸, ۱۸.۸۷ and ۱۷.۷۹ % and for reduced-dose was ۳۸.۸۵, ۳۶.۰۶ and ۳۴.۹۸ %. In long term stability, the quality control tests including colony forming unit , purity, dissociation and physicochemical tests in all samples until ۲۴ months, met the specification recommended by OIE ۲۰۱۲. The full-dose vaccines showed a mean loss of activity of ۳۰.۷۳, ۲۵.۵۳ and ۳۲.۴۵ % and the reduced-dose vaccines showed ۶۳.۵۱, ۵۸.۶۰ and ۶۰.۸۳ %. The mean increasing of moisture content was, ۱۸۷.۸۵, ۲۱۴.۱۳ and ۱۶۰.۷۷ % for full-dose and ۱۴۲.۳۵, ۱۱۰.۲۳ and ۱۶۴.۴۷ % for reduced-dose. So, the results of this research indicated in spite of moisture content increasing in second year, the brucellosis vaccines with this strain are stable at least ۲۴months if the cold chain considered properly but the best expiry date for the vaccine is one year.

Keywords:

Stability study , Brucella abos , quality control , vaccine