北京希济生物科技有限公司

北京希济生物科技有限公司(以下简称“希济生物”)是一家总部位于北京, 拥有总面积超8,000平米符合FDA、EMA、NMPA标准的CGT cGMP厂房设施,可为 基因细胞药物客户提供从科研级到商业化级的质粒、病毒、细胞产品的生产服务, 致力于成为其最佳合作伙伴。截至发文日已累计成功支持申报7项IND获批。希济生 物总计18条GMP生产线。质粒平台配备2条独立生产线,全流程单向流设计,可实 现 3 L-200 L快速高密度发酵工艺,产量最高达克级/L;病毒平台配备3条独立病毒生 产线,全流程单向流、负压、全新风设计,可实现3 L-200 L灵活放大的病毒载体生 产,另配备2条细胞建库生产线;细胞平台包括B+A及C+A环境,拥有5个独立区域 共11条生产线,可提供自体和异体细胞治疗药物的工艺开发及生产制备等服务;质 控平台拥有80+分析检测方法,可为客户提供各平台的分析方法学开发、分析方法确 认、分析方法验证、样品放行检测、原辅包检测及环控等质控相关服务。 

Beijing Cygenta Biotech Co., Ltd. (hereinafter referred to as "Cygenta") is  headquartered in Beijing and operates a state-of-the-art CGT cGMP facility spanning  over 8,000 square meters. Our facility complies with FDA, EMA, and NMPA standards,  positioning us as a leading Contract Development and Manufacturing Organization  (CDMO) for gene and cell therapies.At Cygenta, we provide comprehensive  production services for plasmids, viral vectors, and cell products, supporting clients from research-grade to commercial-grade manufacturing. As of now, our commitment  to excellence has enabled us to successfully support seven Investigational New  Drug (IND) applications. We are dedicated to becoming the premier partner for gene  and cell therapy companies, offering unparalleled expertise and infrastructure to  accelerate the development and commercialization of life-changing therapies.

 

地址:北京市大兴区生物医药基地天贵大街7号院1号楼

Building 1, No.7 Tiangui Street, Tiangongyuan Street,

Daxing District, Beijing

电话:010-89288951

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