蜂巢培养系统在细胞扩增培养过程中的优势与应用  

Advantages and application of beehive incubator management system in cell expansion and culture

作　　者：程锦生 Cheng Jinsheng(Shanghai tofflon medical equipment Co.,Ltd,Shanghai 201108,China)

机构地区：[1]上海东富龙医疗装备有限公司,上海201108

出　　处：《化工与医药工程》2021年第4期31-35,共5页Chemical and Pharmaceutical Engineering

摘　　要：蜂巢培养系统是自主开发的细胞药品化生产设备,在研发设计时即充分考虑细胞治疗产品生产的GMP法规符合性及成本控制要求,该系统可有力保障细胞治疗产品生产制备的安全性及有效性,同时减少人员及场地等投入,提高生产效率等。在蜂巢培养系统中验证测试不同的细胞药品化生产的代表性工艺,证实其可应用于多种细胞治疗产品生产,满足GMP规范下细胞治疗产品药品化及规模化生产要求。The beehive incubator management system is a self-developed equipment for the manufacture of cell drugs,fully considered in GMP regulatory compliance and cost control requirement in the process of the research and development design production of cell therapy products.This system could effectively ensure the safety and effectiveness of drug preparation and production,while reducing personnel and site investment and improve efficiency and so on.We verified and tested the representative technology of different cell drug in the beehive incubator management system,and proved that it could be applied to a variety of cell drugs production,to meet the requirements of cell pharmaceutical production and large-scale production under GMP regulatory requirements.

关 键 词：细胞药品化 蜂巢培养系统 合规性 成本控制 规模化 

分 类 号：TQ460.6[化学工程—制药化工]