生产场地变更注册的疫苗质量可比性研究

摘要

Objective To compare the key quality indicators before and after live attenuated varicella vaccine (varicella vaccine)manufacturing site relocation,and to study the regulation of registration development.Methods The domestic varicella vaccine manufacturer produced 3 batches of varicella vaccines each,in old and new facility production workshops simultaneously.The key quality indicators,stability and safety of vaccine were compared.Results The key quality indicators,stability and safety of varicella vaccines produced in old and new facilities were all in accordance with registration standards.The moisture contents of varicella vaccine from new and old facilities were 1.1 ％-1.4％ and 1.1％-1.3％,respectively.Virus titers were both 3.9-4.0 lg plaque-forming unit/ml.Bovine serum albumin residues were 15-18 and 17-23 ng/ml.Antibiotic residues were 0.2-0.5 and 0.4-5.0 ng/dose.The results between old and new facilities were similar.Conclusion Manufacturing site relocation does not affect the quality of varicella vaccine and registration regulation is effective.%目的 对水痘减毒活疫苗(水痘疫苗)生产场地变更前后的关键质量指标进行比较,并研究注册研制的监管.方法 国内一家水痘疫苗生产企业的原生产车间、新生产车间同步生产各3批水痘疫苗,进行关键质量指标、稳定性和安全性比较研究.结果 原车间、新车间生产的水痘疫苗关键质量指标、稳定性和安全性比较研究均符合注册标准.新车间与原车间生产的水痘疫苗的水分(1.1％～1.4％、1.1％～1.3％)、病毒滴度(均为3.9～4.0)lg蚀斑形成单位/ml)、牛血清白蛋白残留量(15～18、17～23 ng/ml)、抗生素残留量(0.2～.5、0.4～5.0 ng/剂)相似.结论 生产场地变更未对水痘疫苗质量产生影响,注册监管是有效的.