| 引用本文: | 厉高慜,潘伟婧,陈鑫,邵泓,陈钢.呼吸信号检测的快速微生物方法应用于细胞制品无菌检查的研究[J].中国现代应用药学,2020,37(21):2594-2598. |
| LI Gaomin,PAN Weijing,CHEN Xin,SHAO Hong,CHEN Gang.Study of Respiration Signal Based Rapid Microbiological Method for Sterility Testing of Cell Therapy Products[J].Chin J Mod Appl Pharm(中国现代应用药学),2020,37(21):2594-2598. |
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| 呼吸信号检测的快速微生物方法应用于细胞制品无菌检查的研究 |
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厉高慜1, 潘伟婧2, 陈鑫3, 邵泓1, 陈钢1
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1.上海市食品药品检验所国家药品监督管理局治疗类单抗质量控制重点实验室, 上海 201203;2.上海市食品药品检验所国家药品监督管理局化学药品制剂质量分析重点实验室, 上海 201203;3.华道(上海)生物医药有限公司, 上海 201203
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| 摘要: |
| 目的 评价基于呼吸信号检测原理的VersaTrek®快速微生物检测系统作为药典替代方法用于细胞制品无菌检查的可行性。方法 以CAR-T细胞为应用对象，参考中国药典2015年版通则9201和其他国外指导原则，研究快速方法在专属性、检测限、重复性和耐用性方面是否可替代药典方法。结果 各参数的验证结果表明快速方法不劣于药典方法。结论 在经验证的前提下，VersaTrek®系统可作为药典无菌检查的替代方法用于特定细胞产品的快速放行。 |
| 关键词: 快速无菌检查 细胞制品 替代方法 VersaTrek® |
| DOI：10.13748/j.cnki.issn1007-7693.2020.21.006 |
| 分类号:R927.1 |
| 基金项目:国家药典委员会药品医疗器械审评审批制度改革有关药品标准研究子项目（ZG2018-4-01） |
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| Study of Respiration Signal Based Rapid Microbiological Method for Sterility Testing of Cell Therapy Products |
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LI Gaomin1, PAN Weijing2, CHEN Xin3, SHAO Hong1, CHEN Gang1
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1.NMPA Key Laboratory for Quality Control of Therapeutic Monoclonal Antibodies, Shanghai Institute for Food and Drug Control, Shanghai 201203, China;2.NMPA Key Laboratory for Quality Analysis of Chemical Drug Preparations, Shanghai Institute for Food and Drug Control, Shanghai 201203, China;3.Huadao Biopharm Co., Ltd, Shanghai 201203, China
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| Abstract: |
| OBJECTIVE To evaluate feasibility of that VersaTrek® rapid microbial detection system based on respiratory signal detection technology, as an alternative to pharmacopoeia, it can be used for sterility test of cell therapy products. METHODS CAR-T cells were involved to investigate whether the compendial method could be replaced with the rapid method by testing the specificity, limit of detection, repeatability and ruggedness of methods refering to the Chinese Pharmacopoeia 2015 General Chapter 9201 and other foreign guidelines. RESULTS The validation results of each parameter indicate that the rapid method was not inferior to the compendial method. CONCLUSION Under the premise of validation, the VersaTrek® system can be used as an alternative method to compendia sterility testing for rapid release of specific cell products. |
| Key words: rapid sterility test cell therapy product alternative method VersaTrek® |
