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目的了解Vero细胞疫苗中间产品中宿主细胞蛋白(Host cell protein,HCP)的含量变化。方法模拟Vero细胞疫苗生产工艺流程,制备Vero细胞HCP,免疫家兔制备Vero细胞HCP免疫血清,经Protein ASepharose CL-4B亲和层析,制备纯化的抗Vero细胞HCPIgG,通过SDS-PAGE和Western blot分析Vero细胞乙型脑炎疫苗及Vero细胞SARS疫苗各中间产品的蛋白、HCP及病毒抗原成分的含量变化。结果Vero细胞乙型脑炎疫苗和Vero细胞SARS疫苗中间产品中均存在一定量HCP,不同的纯化工艺均可以去除大部分HCP,随着生产工艺的进行,疫苗中间产品中HCP的含量逐渐降低,病毒成分的纯度逐渐增高,但纯化后产品中仍存在少量HCP。结论Vero细胞乙型脑炎疫苗和Vero细胞SARS疫苗均存在一定量HCP。
Objective To understand the content of host cell protein (HCP) in Vero cell vaccine intermediate. Methods The Vero cell vaccine production process was simulated and the HCP of Vero cells was prepared. The HCP immune serum of Vero cells was prepared by immunization of rabbits. The purified anti-Vero cell HCPIgG was prepared by Protein ASepharose CL-4B affinity chromatography. SDS-PAGE and Western blot The Vero cell JE vaccine and the Vero cell SARS vaccine intermediate protein, HCP and viral antigen content changes were analyzed. Results A certain amount of HCP existed in the Vero cell JE vaccine and the Vero cell SARS vaccine intermediate product, and most of the HCPs could be removed by different purification processes. As the production process progressed, the HCP content in the vaccine intermediate product gradually decreased, The purity of the virus components gradually increased, but there are still a small amount of HCP in the purified product. Conclusions There is a certain amount of HCP in both Vero cell encephalitis vaccine and Vero cell SARS vaccine.