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Ma X.-H.,Shanghai Institute of Biological Product Co. | Shen J.,Shanghai Institute of Biological Product Co. | Chen Z.-W.,Shanghai Institute of Biological Product Co. | Wang L.,Shanghai Institute of Biological Product Co. | And 2 more authors.
Chinese Journal of Biologicals | Year: 2014

Objective To evaluate the stability of domestic live attenuated varicella vaccine. Methods Forty batches of live attenuated varicella vaccine manufactured by Shanghai Institute of Biological Products Co., Ltd. (SIBP) in 2007-2013 were subjected to overall control tests according to the standard for license of live attenuated varicella vaccine approved by the SFDA and the requirements in Chinese Pharmacopoeia (Volume HI, 2010 edition). Heat stability test was performed at month 0, while identity test, physical examination, as well as tests for moisture, sterility, abnormal toxicity, residual bovine serum albumin and residual antibiotic (manufactured after October 2010) at months 0 and 18, and virus titration at months 0, 6, 12 and 18. Results All the quality indexes of live attenuated varicella vaccine manufactured by SIBP met the standard for license of live attenuated varicella vaccine and the requirements in Chinese Pharmacopoeia (Volume III , 2010 edition). Conclusion The live attenuated varicella vaccine manufactured by SIBP was stable, safe and effective. Source

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