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作 者:张益丽 王壮 周巧 李美玲 徐秋玲 古松海 ZHANG Yili;WANG Zhuang;ZHOU Qiao;LI Meiling;XU Qiuling;GU Songhai(Yunnan Precision Inspection Co.,Ltd.,Kunming 650000,China;Cytocraft Biopharmaceutical Co.,Ltd.,Kunming 650000,China)
机构地区:[1]云南精准检验有限公司,昆明650000 [2]赛德特生物制药有限公司,昆明650000
出 处:《中国药学杂志》2025年第5期532-538,共7页Chinese Pharmaceutical Journal
摘 要:目的 建立人链式激活免疫细胞制剂的质控方法。方法 采用共培养加流式细胞分析检测分泌细胞因子能力和体外杀伤活性;流式细胞仪分析测定纯度;吖啶橙/碘化丙锭(AO/PI)双荧光细胞计数仪测定活细胞浓度及细胞活率;以酶联免疫吸附法测定细胞因子残留;实时荧光定量聚合酶链式反应(qPCR)检测支原体核酸;其余检测项目按《中国药典》2020年版三部规定进行。结果 用建立的方法对人链式激活免疫细胞制剂进行了检测,生物学活性研究、理化特性研究、细胞因子残留等各项检测结果符合正态性分布,检测结果有效,且其变异系数(CV)均小于20%。其余各项指标均符合《中国药典》2020年版三部的要求。结论 初步建立了人链式激活免疫细胞制剂的质控方法,具有保证该细胞制剂质量可控、安全有效的特征,可用于该细胞制剂的质量控制。OBJECTIVE To establish a quality control method of human chain-activated immune cell preparations.METHODS The ability to secrete cytokines and in vitro cytotoxicity were detected by co-culture and flow cytometry analysis.Purity was determined by flow cytometry.The concentration of live cells and cell viability were determined by AO/PI dual fluorescence cell counter.The residual cytokines were determined by enzyme-linked immunosorbent assay.Mycoplasma nucleic acid was detected by probe real-time PCR.Other detection items were carried out according to the provisions of the 3rd part of Chinese Pharmacopoeia 2020.RESULTS The detection of human chain-activated immune cell preparations was carried out using the established method,and the RESULTS of biological activity research,physical and chemical characteristics research,and cytokine residual detection were normally distributed.The detection RESULTS were valid,and the coefficient of variation(CV)was less than 20%.All other indicators met the requirements of the Chinese Pharmacopoeia 2020.CONCLUSION A preliminary quality control method of human chain-activated immune cell preparations are established,which has the characteristics of ensuring the quality control lability,safety,and effectiveness of the cell preparations.It can be used for the quality control of the human chain-activated immune preparations.
关 键 词:人链式激活免疫细胞制剂 生物学活性 质量研究 免疫细胞治疗
分 类 号:R945[医药卫生—微生物与生化药学]
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