目的:对重组新型冠状病毒XBB.1.5变异株疫苗(5型腺病毒载体)毒种进行质量评价。方法:利用PCR和琼脂糖凝胶电泳对毒种进行腺病毒载体鉴别和目的基因鉴别,以鉴别其载体是否为腺病毒载体、插入序列是否正确;对毒种进行病毒感染滴度(IFU)检测,以评估其病毒感染力;对毒种进行无菌检查、支原体检查、外源病毒因子检查、腺相关病毒(AAV)检测,以检测是否有外源性污染。结果:腺病毒载体和插入片段均正确,毒种具有很高的感染力,且无细菌、真菌、支原体、外源病毒因子、腺相关病毒(AAV)污染。结论:重组新型冠状病毒XBB.1.5变异株疫苗(5型腺病毒载体)毒种质量符合已上市同类产品质量标准,鉴别、活性和安全性指标检验方法对于疫苗生产具有指导意义。
吴小红, 杨立宏, 郑秀玉, 赵丹华, 黄艳秋, 付瑞, 刘欣玉, 李玉华, 叶强
. 重组新型冠状病毒XBB.1.5变异株疫苗(5型腺病毒载体)毒种质量评价[J]. 药物分析杂志, 2023
, 43(12)
: 2165
-2170
.
DOI: 10.16155/j.0254-1793.2023.12.23
Objective: To evaluate the quality of recombinant adenovirus type-5-vectored COVID-19 vaccine seed (XBB.1.5 virus strain). Methods: Conducted viral vector identity and target gene identity by PCR and agarose gel electrophoresis to determine whether it was an adenovirus type vector and whether the insertion fragment was correct; conducted infectious viral titer (IFU) test to evaluate the infectivity of the virus; conducted sterility test, mycoplasma test, extraneous virus agents test, and adeno-associated virus (AAV) test on the virus seed to detect whether there was exogenous contamination. Results: The results showed that the vector and inserted fragment of the virus seed were correct, and the virus seed was with high infectivity and no bacteria, fungi, mycoplasma, extraneous virus agents and adeno-associated virus (AAV). Conclusion: The quality of recombinant adenovirus type-5-vectored COVID-19 vaccine seed (XBB.1.5 virus strain) met the specification of products approved. The viral vector identity and target gene identity, infectious viral titer test and methods about vaccine safety had guiding significance for vaccine production.
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