CN102988415B - 人异基因有核细胞工业化制备自然杀伤性细胞(nk)及注射液 - Google Patents
人异基因有核细胞工业化制备自然杀伤性细胞(nk)及注射液 Download PDFInfo
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- CN102988415B CN102988415B CN201210288669.6A CN201210288669A CN102988415B CN 102988415 B CN102988415 B CN 102988415B CN 201210288669 A CN201210288669 A CN 201210288669A CN 102988415 B CN102988415 B CN 102988415B
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Abstract
Description
序号 | 检测项目 | 设计合格标准 | 实测值 | 结果 |
1 | 细菌内毒素 | ≤5EU/ml | ≤5EU/ml | 合格 |
2 | 支原体 | 阴性 | 阴性 | 合格 |
3 | CD 16+/CD56+ | ≥15% | 18% | 合格 |
4 | CD3-/CD56+ | ≥50% | 80% | 合格 |
5 | CD8+/CD57+ | 8% | 8.5% | 合格 |
6 | 细胞存活率 | ≥96% | 98% | 合格 |
7 | DNA检测 | 无变异 | 无变异 | 合格 |
序号 | 检测项目 | 设计合格标准 | 实测值 | 结果 |
1 | 细菌内毒素 | ≤5EU/ml | ≤5EU/ml | 合格 |
2 | 支原体 | 阴性 | 阴性 | 合格 |
3 | CD 16+/CD56+ | ≥15% | 17% | 合格 |
4 | CD3-/CD56+ | ≥50% | 79% | 合格 |
5 | CD8+/CD57+ | 8% | 8.3% | 合格 |
6 | 细胞存活率 | ≥96% | 97% | 合格 |
7 | DNA检测 | 无变异 | 无变异 | 合格 |
序号 | 检测项目 | 设计合格标准 | 实测值 | 结果 |
1 | 细菌内毒素 | ≤5EU/ml | ≤5EU/ml | 合格 |
2 | 支原体 | 阴性 | 阴性 | 合格 |
3 | CD 16+/CD56+ | ≥15% | 17% | 合格 |
4 | CD3-/CD56+ | ≥50% | 81% | 合格 |
5 | CD8+/CD57+ | 8% | 8.2% | 合格 |
6 | 细胞存活率 | ≥96% | 99% | 合格 |
7 | DNA检测 | 无变异 | 无变异 | 合格 |
Claims (3)
Priority Applications (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN201210288669.6A CN102988415B (zh) | 2012-08-15 | 2012-08-15 | 人异基因有核细胞工业化制备自然杀伤性细胞(nk)及注射液 |
US14/420,141 US10125351B2 (en) | 2012-08-15 | 2012-12-19 | Industrial preparations of natural killer (NK) cells and injections containing NK cells |
PCT/CN2012/086898 WO2014026457A1 (zh) | 2012-08-15 | 2012-12-19 | 人异基因有核细胞工业化制备自然杀伤性细胞(nk)及注射液 |
EP12882908.2A EP2878666B1 (en) | 2012-08-15 | 2012-12-19 | Industrial preparation of natural killer cells (nks) and injection using human allogeneic karyocytes |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN201210288669.6A CN102988415B (zh) | 2012-08-15 | 2012-08-15 | 人异基因有核细胞工业化制备自然杀伤性细胞(nk)及注射液 |
Publications (2)
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