【摘要】 为了检测高效表达鸡马立克氏病病毒gB基因的重组鸡痘病毒(rFPV-gB/R)的纯净性,对纯化后的0代重组病毒毒种进行了细菌和支原体检验;并对中间试制的冻干疫苗在-20℃保存期进行了测定。结果表明,重组病毒毒种高度纯净,没有污染任何细菌或支原体,符合新制品制造和检验规程申报的要求;中试冻干疫苗在-20℃保存了12个月,病毒含量始终大于109PFU/mL,疫苗保存期可达12个月。更多还原

【Abstract】 Purity assay was performed with the original recombinant fowlpox virus expressing gB gene of Marek’s disease virus,and the valid storage time of pilot product of lyophilized rFPV-gB/R vaccine was determined.The results showed that rFPV-gB/R was free from exogenous bacterial and mycoplasma,which was in accordance with the requirements of new product manufacture and regulation declaration.The experiment of determining the valid storage time of the vaccine demonstrated that the vaccine product remained effective for 12 months at preservation temperature of-20℃.更多还原