Vero细胞疫苗生产过程中宿主细胞蛋白含量分析

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。

Analysis of Host Cell Protein Content During Production of Vero Cell-derived Vaccine

Objective To explore the change of host cell protein(HCP) content in the intermediate product during production of Vero cell-derived vaccine.Methods Prepare the HCP of Vero cells by imitating the production process of Vero cell-derived vaccine.Immunize rabbit with the HCP to obtain immune sera,and prepare purified IgG against Vero cell HCP by Protein A Sepharose CL-4B affinity chromatography.Analyze the changes of protein,HCP and virus antigen contents in intermediate product during production of Vero cell-derived Japanese encephalitis(JE) vaccine and Vero cell-derived SARS vaccine by SDS-PAGE and Western blot.Results HCPs were observed in both the intermediate product during production of Vero cell-derived Japanese encephalitis vaccine and Vero cell-derived SARS vaccine.Most HCP might be removed by purification process.During production,the HCP in intermediate product decreased gradually,and the purity of virus component increased gradually.However,a small quantity of HCP still existed in the purified product.Conclusion The HCP existed in both JE and SARS vaccines prepared with Vero cells.