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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 key quality attributes of the diphtheria toxoid solution and the finished product of the adsorption-free acellular diphtheria toxin conjugate vaccine produced by Chengdu Institute of Biological Products Co., Ltd. from 2007 to 2013. Methods: The trend of diphtheria toxoid and the method of contrast analysis between laboratories were established. Results: The quality of diphtheria toxoid and the problems and deviations in the process of producing diphtheria toxins were found in time, and the influencing factors of the problems and deviations were identified. CONCLUSIONS: The stability of the diphtheria toxoid production and assay procedures in Chengdu was demonstrated, and the quality of diphtheria toxoid is stable.