SARS灭活疫苗的研制及其质量控制

Preparation of Inactivated SARS Vaccine

目的研究适合SARS病毒灭活疫苗的生产工艺及其质量控制。方法连续制备3批疫苗,按拟定规程进行疫苗原液和疫苗各项指标检测。结果各项检测指标均符合拟定规程规定。结论我所生产的SARS灭活疫苗工艺稳定,质量可控。

Objective To explore the production procedure and quality control of inactivated SARS vaccine. Methods Prepare three serial batches of inactivated SARS vaccine and perform control tests on the bulk and final product according to Requirements for Inactivated Severe Acute Respiratory Syndrome Vaccine（Draft）. Results All the quality indexes met the Requirements for Inactivated Severe Acute Respiretory Syndrome Vaccine（Draft）. Conclusion The production procedure of inactivated SARS vaccine developed by Wuhan Institute of Biological Products was stable, and the vaccine was qualified.