Abstract
Accelerated and stress condition tests can be used to understand the stability of the vaccine in the short-term deviation from the preservation conditions and extreme conditions. In this study, we tested three batches of HPV trivalent vaccines that were prepared in the pilot plant and stored in the prefilled syringes at 2 to 8°C. The tests of stability include identity, appearance, the volume of fill, pH, osmolarity, aluminum content, polysorbate-80 content, sterility test, bacterial endotoxin, abnormal toxicity, in vitro relative potency analysis, and in vivo potency evaluation. According to the results, the pH was slightly increased, the polysorbate-80 content was decreased slowly, and ED50 values of HPV16, HPV18, and HPV58 were slightly elevated compared with day 0. According to the tests above, the storage condition of the HPV trivalent vaccine is determined to be 2 to 8°C avoiding light.
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Details
1 Quality Department of Beijing Health Guard Biotechnology Inc., BDA, Daxing District, Beijing 100176, China; National Key Laboratory of Biochemical Engineering, Institute of Process Engineering, Chinese Academy of Sciences, Beijing 100190, China; School of Chemical and Engineering, University of Chinese Academy of Sciences, Beijing 100049, China
2 Research and Development Department of Beijing Health Guard Biotechnology Inc., BDA, Daxing District, Beijing 100176, China
3 Quality Department of Beijing Health Guard Biotechnology Inc., BDA, Daxing District, Beijing 100176, China
4 National Key Laboratory of Biochemical Engineering, Institute of Process Engineering, Chinese Academy of Sciences, Beijing 100190, China