摘要
由于疫苗生产产业化和法规升级等因素的要求,疫苗生产场地需要进行变更。可比性研究有利于控制场地变更对疫苗安全性、有效性带来的风险,是变更成功的桥梁。本文结合国内外技术指导原则的解读和疫苗产品的特点,对我国疫苗场地变更的质量可比性研究作一综述。
Increase in product yield and complementation of the requirement of national regulatory agency are driving to site changes of vaccines. Comparability exercise is the bridge to a successful change, which would ascertain that introduction of the manufacturing site change did not alter the safety and efficacy profile of the product, This paper introduced the core element of the international guideline, and put forwards considerations on designing and fulfilling comparability study regards to vaccine quality assessment.
出处
《中国生物制品学杂志》
CAS
CSCD
2013年第2期289-291,296,共4页
Chinese Journal of Biologicals
关键词
疫苗
场地变更
可比性
Vaccine
Manufacturing site change
Comparability