Stability and safety study for establishing the shelf-life of anthrax-blackleg vaccine
2009
Jang, H. (Komipharm Co., Shihung, Republic of Korea), E-mail: [email protected] | Kwak, H.Y. (Komipharm Co., Shihung, Republic of Korea) | Park, M.S. (Komipharm Co., Shihung, Republic of Korea) | Youn, S.H. (Komipharm Co., Shihung, Republic of Korea) | Moon, S.C. (Komipharm Co., Shihung, Republic of Korea) | Yang, D.K. (National Veterinary Research and Quarantine Service, Anyang, Republic of Korea)
Anthrax and blacking are the important zoonotic diseases in the world. To prevent these diseases effectively, the efficacious safe vaccine is essential. The shelf-life period of vaccine is determined by its safety test and efficacy test and it is closely related to the storage conditions. For establishing the shelf life of vaccine, we performed the safety and stability of 3 lots of commercial anthrax-blackleg combined vaccine. The tests are divided into animal test and biophysical test. The safety test was performed using guniea pig and cow for 7~21 days. During the test period, we could not see any adverse effect and clincal symptoms from the tested animals. The number of live spore of Bacillus anthracis sterne F34 strain and Clostridium chauvoei attenuated strain in the vaccine was consistently maintained as many as 9.6×10∨7 CFU/dose and 3.0×10∨6 CFU/dose respectively. In addition, no physical change of vaccine antigen and additive(excipient) was detected. Base on the test results, we conclude that safety, stability and efficacy of the vaccine may be maintained for 24 months from the manufactring.
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