吸附无细胞百白破联合疫苗中白喉类毒素的质量分析

Quality analysis of diphtheria toxoid in DTaP vaccine

目的:对成都生物制品研究所有限责任公司2007-2013年生产的吸附无细胞百白破联合疫苗中白喉类毒素的原液和成品的关键质量属性进行分析。方法:建立了白喉类毒素趋势分析和实验室间对比分析的方法。结果:及时发现了白喉类毒素的质量和生产过程中发生的问题及偏差,确定了产生问题和偏差的影响因素。结论:证明了成都公司白喉类毒素生产和检定过程的稳定性,白喉类毒素的质量是稳定的。

Objective： To analyze the critical quality attribution of diphtheria toxoid produced by Chengdu Institute during 2007 -2013. Methods： The Trend Analysis and Data Comparison Analysis methods were estab- lished. Results： The changes and bias in the production and quality control process were detected. The factors af- fected the quality of products were found. Conclusion ： The quality of diphtheria toxoid produced by Chengdu Insti- tute is stable.