| Premium 级别 | GMP级别 | |
|---|---|---|
| 应用 | 早期研发和临床前研究，无缝衔接GMP级别 | 为满足临床阶段需求而设计，用于商业化生产 |
| 质量体系 | ISO9001/ISO13485质量认证体系 | ISO9001/ISO13485质量认证体系（研发阶段）+GMP质量体系（生产阶段） |
| 生产 | ISO认证的普通级别厂房 | 经过第三方权威认证的GMP洁净厂房 |
| 瞬转/稳定株 | 稳定株（按药典要求全面外检，确保无病毒支原体等外源污染） | |
| 多数AOF原材料 | AOF原材料 | |
| 关键辅料为药用级 | 关键辅料为药用级 | |
| 经严格二级除菌过滤 | 经严格二级除菌过滤 | |
| 百级层流手动灌装 | B+A全自动灌装 | |
| 无特定的病毒去除/灭活工艺 | 增加特定的病毒去除/灭活工艺步骤(纳滤和低pH) | |
| 质检 | 无菌/支原体检测 | 无菌/支原体检测 |
| 内毒素控制及检测 | 内毒素控制及检测 | |
| 关键生产设备/分析仪器经过验证 | 生产设备/分析仪器/关键分析方法经过严格验证，分析仪器审计追踪 | |
| 工艺相关杂质: DNA, HCP，工艺残留 | 工艺相关杂质: DNA, HCP，工艺残留 | |
| 无额外安全性检测 | 增加相关病毒残留、动物体内安全性实验（异常毒性，急毒等) | |
| 配套文档 | 必要的文件或声明 | 完善的二级法规支持文档 |
| 少数产品DMF备案 | 所有产品DMF备案 |
| 产品类别 | GMP级别 | Premium级别 |
|---|---|---|
| 细胞因子 | GMP Human IL-7 | Human IL-7 Protein, premium grade |
| GMP Human IL-15 | Human IL-15 Protein, premium grade | |
| GMP Human IL-21 | Human IL-21 Protein, premium grade | |
| GMP Human IL-18 | Human IL-18, premium grade | |
| GMP Human TNF-alpha | Human TNF-alpha, premium grade | |
| GMP Human GM-CSF | Human GM-CSF, premium grade | |
| GMP Human IL-6 | Human IL-6, premium grade | |
| GMP Human IL-4 | Human IL-4, premium grade | |
| GMP Human IFN-gamma | Human IFN-gamma, premium grade | |
| 抗体 | GMP Monoclonal Anti-Human CD3 Antibody(OKT3) | Monoclonal Anti-Human CD3 Antibody, Mouse IgG2a (Clone: OKT3), premium grade |
| GMP Monoclonal Anti-Human CD28 Antibody | Monoclonal Anti-Human CD28 Antibody, Mouse IgG1, premium grade | |
| 激活磁珠 | GMP Anti-CD3/CD28 Antibody-coupled Magnetic Beads | Anti-CD3/CD28 Antibody-coupled Magnetic Beads, premium grade |
| 全能核酸酶 | GMP GENIUS™ Nuclease | GENIUS™ Nuclease, premium grade |
| Cas酶 | GMP NLS-Cas9 Nuclease | NLS-Cas9 Nuclease, premium grade |
Recombinant Human IL-15 Protein premium grade (IL5-H4117), designed for preclinical stage, has the same activity and performance with GMP Grade IL-15 (GMP-L15H13), which enables a seamless transition from preclinical development to clinical phases .
申请 Protocol
Human IL-7 Protein premium grade (IL7-H4219) designed for preclinical stage, has the same activity and performance with GMP Grade IL-7 (GMP-L07H24), which enables a seamless transition from preclinical development to clinical phases .
申请 Protocol
Bioactivity of three different lots of GMP Human IL-15 (GMP-L15H13) verified by cell-based assay, and the result shows very high batch-to-batch consistency.
申请 Protocol
The Cell based assay shows that GMP Human IL-7 (GMP-L07H24) is stable at 37°C for 48 hours and after freezing and thawing 3 times.
申请 Protocol
膜杰作
Star Staining
ViruStop
Aneuro
ComboX
ActiveMax
GENPower
ClinMax
Star Ribbon
