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 |
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 |
/ |
/ |
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 |
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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 |