GMP级细胞因子&活性蛋白
Proteintech已通过ISO13485认证，GMP标准车间及流程生产:
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原材料的鉴定、记录和可追溯性
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定期检查和确认洁净厂房和仪器
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经过验证的工艺和标准化操作程序
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明确的标准和过程检验规范(IPQC)
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系统和有组织的人员培训计划
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偏差管理及纠正和预防措施(CAPA)
由于从原材料的质量到过程中的不一致性等各种原因，体外重组蛋白的生产容易发生变化。HumanKine® GMP（现行良好生产规范）重组蛋白按照ISO 13485质量管理体系进行生产和验证，并符合GMP标准。
根据USP（美国药典）第1043章细胞、基因和组织工程产品的辅助材料、细胞治疗制造中使用的生长因子和细胞因子的定义及WHO TRS，1992年第822号附录1生物产品的良好生产规范，HumanKine® GMP重组蛋白的安全性、纯度、稳定性和效力允许进行体外生产。
GMP Grade Cytokines and Growth Factors
All HumanKine cytokines and growth factors are expressed in HEK293 cells.
| Product | Activity (EC 50) | Purity |
|---|---|---|
| Activin A | 0.5-3.5 ng/mL | >95% |
| BMP-2 | 7.5-37.5 ng/mL | >95% |
| BMP-4 | 1.5-9 ng/mL | >95% |
| Cystatin C | 0.5-2.6 µg/mL | >95% |
| FGFbasic-TS | 0.07-0.4 ng/mL | >95% |
| FLT3 Ligand | 0.4-3.0 ng/mL | >95% |
| G-CSF | 0.009-0.05 ng/mL | >95% |
| GM-CSF | 0.08-0.8 ng/mL | >95% |
| HGH | 0.02-0.120 ng/mL | >95% |
| HSA | N/A | >95% |
| IFN alpha 2B | 0.004-0.02 ng/mL | >95% |
| IFN gamma | 0.02-0.14 ng/mL | >95% |
| IGF-I | 2-14 ng/mL | >95% |
| IL-2 | 0.05-0.35 ng/mL | >95% |
| IL-3 | 0.4-2.0 ng/mL | >95% |
| IL-4 | 0.07-0.4 ng/mL | >95% |
| IL-6 | 0.03-0.24 ng/mL | >95% |
| IL-7 | 0.2-1.4 ng/mL | >95% |
| IL-9 | 0.1-0.6 ng/mL | >95% |
| IL-10 | 0.18-2.0 ng/mL | >95% |
| IL-12 | 1-5 ng/mL | >95% |
| IL-15 | 3-17 ng/mL | >95% |
| IL-28A | 0.01-0.06 ng/mL | >95% |
| M-CSF | 0.7-4.0 ng/mL | >95% |
| Noggin | 3-15 ng/mL | >95% |
| PDGFbb | 0.3-3 ng/mL | >95% |
| SCF | 15-85 ng/mL | >95% |
| TGF beta 1 | 0.01-0.17 ng/mL | >95% |
| TGF beta 2 | 0.018-0.18 ng/mL | >95% |
| TGF beta 3 | 0.15-0.75 ng/mL | >95% |
| TNF alpha | 0.002-0.026 ng/mL | >95% |
| VEGF165 | 0.3-3.75 ng/mL | >95% |
| Wnt3A | 25-125 ng/mL | >90% |
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Request for your GMP protein of interest hereProteintech's GMP Facility in Chicago, IL
