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本报讯 记者杨阳腾报道:深圳合一康生物科技股份有限公司日前宣布,其人体细胞银行获得全球先进输血和细胞治疗联盟(AABB)认证证书,标志着国内首家专业人体免疫细胞库获得细胞治疗行业质量管理国际权威认证。
创立于1947年的AABB原为美国血库协会,于2005年更名为全球先进输血和细胞治疗联盟,是全球从事输血及细胞治疗行业的国际权威认证组织,其认证具有全球行业最高标准。
“AABB标准在很多方面要求比较高。”合一康生物科技股份有限公司创始人罗晓玲介绍,比如对供体的传染病筛查,会要求检查更多的传染性病毒。此外,实验室人员必须经过严格的上岗培训和能力认定;制备设备和工艺必须经过验证,并对整个体系关键数据进行电子化管理……“我们旨在以最严格质量标准确保产品和服务品质与质量安全,主动规范细胞行业生产作业标准,以期对国内细胞治疗行业质量管理起到积极的示范和推动作用。”罗晓玲说。
据悉,近十年来,细胞技术在癌症治疗、再生医学等领域展现出良好的应用前景,我国细胞治疗技术获得了高速发展。然而,相关监管政策和行业标准制定一直滞后于行业的快速发展。因此,制定细胞制剂的制备标准和操作规范,建立一系列的技术应用管理规范和建立安全有效的技术评价机制势在必行。
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