The use of different stabilizers for improving integrity of the locally prepared lyophilized Brucella melitensis Rev 1 vaccine
A. Ghazy, N., R. Abd El-Aziz, W., H.M., I., W.S., S., H.I., H. (2018). The use of different stabilizers for improving integrity of the locally prepared lyophilized Brucella melitensis Rev 1 vaccine. EKB Journal Management System, 25(1), 59-67. doi: 10.21608/jvmr.2018.43302
Nabila A. Ghazy; Wafaa R. Abd El-Aziz; Ibrahim H.M.; Shell W.S.; Hosein H.I.. "The use of different stabilizers for improving integrity of the locally prepared lyophilized Brucella melitensis Rev 1 vaccine". EKB Journal Management System, 25, 1, 2018, 59-67. doi: 10.21608/jvmr.2018.43302
A. Ghazy, N., R. Abd El-Aziz, W., H.M., I., W.S., S., H.I., H. (2018). 'The use of different stabilizers for improving integrity of the locally prepared lyophilized Brucella melitensis Rev 1 vaccine', EKB Journal Management System, 25(1), pp. 59-67. doi: 10.21608/jvmr.2018.43302
A. Ghazy, N., R. Abd El-Aziz, W., H.M., I., W.S., S., H.I., H. The use of different stabilizers for improving integrity of the locally prepared lyophilized Brucella melitensis Rev 1 vaccine. EKB Journal Management System, 2018; 25(1): 59-67. doi: 10.21608/jvmr.2018.43302

The use of different stabilizers for improving integrity of the locally prepared lyophilized Brucella melitensis Rev 1 vaccine

Journal of Veterinary Medical Research
Article 5, Volume 25, Issue 1, June 2018, Page 59-67  XML PDF (626.98 K)
Document Type: Original Article
DOI: 10.21608/jvmr.2018.43302
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Authors
Nabila A. Ghazy1; Wafaa R. Abd El-Aziz1; Ibrahim H.M.1; Shell W.S.2; Hosein H.I.3
1Veterinary Serum and Vaccine Research Institute (VSVRI), Abbasia, Cairo.
2Central Laboratory for Evaluation for Veterinary Biologics (CLEVB).
3Faculty of Veterinary Medicine, Beni-Suef University.
Abstract
Stability study of biological products especially living bacterial vaccines plays an important role for determination of product changes in maintenance period and ensures safety, efficacy and maintenance of biological properties of the vaccines. So, the objective of this study was to establish stability and keeping quality of the local Brucella melitensis Rev-1 vaccine using different types of stabilizers in lyophilization process. A long-term stability study was carried out for four batches of reduced-dose Brucella melitensis Rev-1 vaccine manufactured by veterinary serum and vaccine research institute using four different stabilizers. These stabilizers were (A) sucrose and skimmed milk, (B and C) different concentrations of sucrose, sodium glutamate and gelatin, and (D) casein, sucrose and sodium glutamate. The quality control tests including colony forming unit, purity, dissociation and physicochemical tests on all batches until 12 months post- production were performed. The obtained results indicated that, in spite of collapse (shrinkage) of lyophilized cake in a number of bottles in batches prepared using stabilizer A, the brucella vaccine batches were stable and met the specification recommended by OIE 2012 for 12 months post-production in vaccine batches with stabilizers A and D.
Keywords
REV 1 vaccine – Brucella melitensis – Stabilizer – Stability; PCR
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