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Service Platform

Testing Platform

Our testing platform operates under an Accredited Biosafety Level 2 (BSL-2) Laboratory, committed to delivering safe, reliable, high-standard, and high-quality testing services. The laboratory strictly adheres to CMA and CNAS regulatory requirements, as well as GMP quality management systems, ensuring the accuracy and reliability of test results.

Our testing methods rigorously comply with pharmacopoeial standards (ChP, USP, EP) and industry regulations (ICH). Equipped with state-of-the-art instruments and operated by experienced professionals, the laboratory ensures full compliance with industry standards at every testing stage.

Our laboratory is committed to providing high-quality testing services, supporting every stage of biopharmaceutical research and production. We consistently uphold rigorous standards to deliver scientific, accurate, and reliable testing data and reports to our clients.

服务类型 阶段 干细胞 CAR-T细胞 基因治疗类 重组蛋白与抗体类 疫苗类
菌种库
病毒库
细胞库检定
IIT
Pre-IND
IND
BLA
外源病毒因子
细胞鉴别
细胞活性
细胞生物学效力等
菌种库检定
PCB、MCB、WCB、
UPC、EOPC、对照细
胞等细胞基质检测
菌种库检定
PCB、MCB、WCB、
UPC、EOPC、对照
细胞等细胞基质检测
病毒种子库检定
菌种库检定
MCB、WCB、
EOPC等细胞基质
检测
VERO、CHO、
HEK293等细胞
库检定
病毒种子库检定

起始原材料
中间体/原料药
原辅料检定

IIT
Pre-IND
IND
BLA
供体筛查 质粒检定
病毒检定
供体筛查
质粒检定
病毒检定

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产品检定 IIT
Pre-IND
IND
表面标记物/纯度
三系分化
生物学效力
无菌、支原体、
内毒素等
纯度(含工艺杂质残
留如HCD、HCP、
非目标细胞等)
密度、活性细胞杀伤
CAR拷贝数、RCL
无菌、支原体、
内毒素,等
目的基因鉴别、
生物学活性、病
毒颗粒数、比活性
纯度(含工艺杂质
HCD、HCP等)
无菌、支原体、
内毒素

/

病毒滴度
HCD、HCP、
内毒素、等
病毒灭活/清除验证 Pre-IND
IND
BLA
工艺变更
N/A N/A 下游病毒灭活
清除工艺验证
清除工艺验证 下游病毒灭活
清除工艺验证