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近日,GE医疗中国生命科学研发培训中心(Fast Trak)二期扩建完成。此次扩建的Fast Trak是在已有中试平台生产线的基础上,按照GMP设计建设了国际一流的中试平台,内置全一次性生产线灵活工厂(Flex FactoryTM),包括从接种间到药物原液的生产线,最大细胞培养规模预计可达500L。扩建的中试平台洁净实验区域占地400平方米,工程间占地200平方米,可以完成细胞复苏、接种、扩增、细胞培养、收获、蛋白质纯化、病毒灭活及过滤、超滤、制剂等生产流程,制备用于临床申报所需的药物原液。全部生产工艺设备为一次性系统,可避免不同产品的交
Recently, Phase II expansion of GE Healthcare’s China Life Science Research and Training Center (Fast Trak) was completed. The expansion of the Fast Trak is based on the existing pilot plant production line, based on GMP design and construction of a world-class pilot platform, built-in one-time production line flexible factory (Flex FactoryTM), including from inoculation to drug solution Production lines, the largest cell culture is expected to scale up to 500L. Expansion of pilot clean test platform covers an area of 400 square meters, the project covers an area of 200 square meters, can complete cell recovery, inoculation, amplification, cell culture, harvest, protein purification, virus inactivation and filtration, ultrafiltration, And other production processes, preparation of drugs for clinical application of liquid stock. All production process equipment for the one-time system, to avoid the exchange of different products