北京义翘神州

细胞因子（cytokine）是一类能在细胞间传递信息，具有免疫调节和效应功能的低分子量蛋白质或小分子多肽，具有促进细胞生成和生长以及修复损伤组织等功能。细胞因子不仅广泛用于生命科学基础研究领域，还用于肿瘤免疫治疗靶点研究，亦可作为培养基补充剂广泛用于细胞培养过程。在肿瘤免疫治疗、干细胞治疗和再生医学的研究及生产过程中，添加细胞因子能够调节细胞增殖和分化、信号转导等，细胞因子也被广泛的用于Car-T细胞的制备和细胞培养等方面。为了确保安全性，对细胞因子有了更高的要求和更严格的标准和管理。

GMP级细胞因子是指在生产过程中按照GMP标准进行，有严格的质量管理体系、规范的质量保证管理以及质量控制体系，最大限度的降低生产过程中的差异性和不确定性，确保细胞因子产品的高质量。GMP级细胞因子与重组药物不同，不能直接用于疾病治疗，可用于细胞治疗的辅助原料，不需要经过药监局批准，但是在生产过程中严格遵守GMP要求。

2022年，国家药监局发布公开征求《药品生产质量管理规范-细胞治疗产品附录（征求意见稿）》意见，对关键物料要求进行风险评估，以确定关键物料有记录，如直接用于细胞产品生产的基因修饰载体或其他起始生物材料、细胞因子、生长因子、酶、血清等。《中国药典》三部中“生物制品生产用原材料及辅料质量控制规程”及国外相关技术要求对原材料的风险等级进行评估并分类，同一种试剂或材料，优先选择低风险级别的，如药用无菌制剂优于药用制剂，药用级优先于非药用级、GMP级优先于非GMP级、非动物源性优先于动物源性材料等。

义翘神州致力于开发高质量的用于细胞治疗研究及临床的相关试剂，在拥有GMP质量管理体系基础上，以更完善的质量管理和放行检测标准，成功开发一系列更高质量的GMP级细胞因子。另有无动物源细胞因子可供选择！

质量管理及质量控制体系

质量管理体系

• 符合《药品生产质量管理规范》
• 符合ISO 9001:2015和ISO 13485:2016质量管理体系
• FDA DMF备案中
• 完整的申报支持文档（RSF）

质量控制体系

• 符合《中华人民共和国药典》2020年版三部通则：生物制品生产用原材料及辅料质量控制
• 符合USP<1043>Ancillary Materials For Cell, Gene, and Tissue-engineered Products
• 符合USP Chapter <92> Growth Factors and Cytokines Used in Cell Therapy Manufacturing

质量保证管理体系

• 专人负责管理人员培训体系
• 建立和运行设备维护和校准程序
• 供应商管理体系和原材料管理体系
• 文件体系和记录管理完全满足GMP规范要求
• 完整的批生产记录、批检验记录、分装记录等
• 质量文件或记录经QA审核和批准

产品安全性检测体系

• 细菌内毒素＜5-10EU/mg
• 宿主蛋白残留检测＜0.5μg/mg（500ppm）
• 宿主DNA残留检测＜100pg/mg
• 支原体检测
• 无菌检测
• 外源病毒检测
• 异常毒性检测

质量体系认证

近7000㎡ 的超洁净车间

北京义翘神州科技股份有限公司建立了近7000㎡ 的超洁净车间，拥有原核生产车间和真核生产车间，配备先进的培养设备和纯化设备，做到生产全过程控制。


反应器
纯化设备
均质机

GMP级细胞因子：高纯度，高活性，高稳定性，高批间一致性

高纯度

Human Interleukin-21 / IL-21 Protein
货号：GMP-10584-HNAE
 Human IL7 / Interleukin 7 Protein
货号：GMP-11821-HNAE
 Human IL-1 beta / IL1B Protein
货号： GMP-10139-HNAE

高活性

Human Interleukin-21 / IL-21 Protein
货号：GMP-10584-HNAE

Induced Interferon gamma secretion by human natural killer lymphoma NK-92 cells		 Human IL7 / Interleukin 7 Protein
货号：GMP-11821-HNAE

Cell proliferation assay using anti-CD3 antibody activated human peripheral blood mononuclear cell (PBMC)		 Human Interleukin-2 / IL-2 Protein
货号：GMP-11848-HNAE

Cell proliferation assay using CTLL2. The specific activity of recombinant human IL-2 is approximately 20,000 IU/μg

高稳定性

Human Interleukin-21 / IL-21 Protein
货号：GMP-10584-HNAE

Induced Interferon gamma secretion by human natural killer lymphoma NK-92 cells

高批间一致性

Human Interleukin-21 / IL-21 Protein
货号：GMP-10584-HNAE

Induced Interferon gamma secretion by human natural killer lymphoma NK-92 cells		   Human IL7 / Interleukin 7 Protein
货号：GMP-11821-HNAE

Cell proliferation assay using anti-CD3 antibody activated human peripheral blood mononuclear cell (PBMC)

GMP级细胞因子产品信息速览

细胞因子 货号 纯度 表达宿主 活性
Flt3 Ligand/
FLT3LG		 GMP-10315-HNAE1-L-AF
(Animal-Free) 		≥95% E. coli Measured in a cell proliferation assay using BaF3 mouse proB cells transfected with mouse Flt3. The ED50 for this effect is typically 1-6 ng/mL.
SCF GMP-10451-HNAE1-L-AF
(Animal-Free) 		≥95% E. coli Measured in a cell proliferation assay using TF-1 human erythroleukemic cells. The ED50 for this effect is typically 1-8 ng/mL.
IL-21 GMP-10584-HNAE1-L-AF
(Animal-Free) 		≥95% E. coli Measured by its ability to induce Interferon gamma secretion by human natural killer lymphoma NK-92 cells. The ED50 for this effect is 0.4-2 ng/ml.
IL-21 GMP-10584-HNAE DMF备案 ≥95% E. coli Induced Interferon gamma secretion by human natural killer lymphoma NK-92 cells.
The ED50 for this effect is 0.4-2 ng/mL.
IL-7 GMP-11821-HNAE DMF备案 ≥95% E. coli Cell proliferation assay using anti-CD3 antibody activated human peripheral blood mononuclear cell (PBMC). The ED50 for this effect is typically 0.5-8 ng/mL. The specific activity of Recombinant Human IL-7 is >100,000 units/μg, which is calibrated against the human IL-7 reference standard (NIBSC code: 90/530).
IL-7 GMP-11821-HNAE-L ≥95% E. coli Cell proliferation assay using anti-CD3 antibody activated human peripheral blood mononuclear cell (PBMC). The ED50 for this effect is typically 0.5-8 ng/mL. The specific activity of Recombinant Human IL-7 is >100,000 units/μg, which is calibrated against the human IL-7 reference standard (NIBSC code: 90/530).
IL-2 GMP-11848-HNAE ≥95% E. coli Cell proliferation assay using CTLL2. The ED50 for this effect is typically 1-8 ng/mL. The specific activity of recombinant human IL-2 is approximately 20,000 IU/μg.
TNF GMP-10602-HNAE ≥95% E. coli Cytotoxicity assay using L929 mouse fibrosarcoma cells in the presence of the metabolic inhibitor actinomycin D. The ED50 for this effect is typically 3-30 pg/mL. The specific activity of recombinant human TNF-alpha is >36,000IU/μg, which is calibrated against the human TNF-alpha WHO International Standard (NIBSC code: 12/154).
TNF GMP-10602-HNAE-L ≥95% E. coli Cytotoxicity assay using L929 mouse fibrosarcoma cells in the presence of the metabolic inhibitor actinomycin D. The ED50 for this effect is typically 3-30 pg/mL. The specific activity of recombinant human TNF-alpha is >36,000IU/μg, which is calibrated against the human TNF-alpha WHO International Standard (NIBSC code: 12/154).
IL-6 GMP-10395-HNAE ≥95% E. coli Cell proliferation assay using TF‑1 human erythroleukemic cells. The ED50 for this effect is 0.1-0.8 ng/mL. The specific activity of recombinant human IL-6 is >100,000IU/μg, which is calibrated against human IL-6 WHO International Standard (NIBSC code: 89/548).
IL-1B GMP-10139-HNAE DMF备案 ≥95% E. coli Induced Interferon gamma secretion by human natural killer lymphoma NK-92 cells. The ED50 for this effect is typically 0.2-2 ng/mL. The specific activity of recombinant human IL-1 beta is >60,000 IU/μg, which is calibrated against the human IL-1 beta WHO International Standard (NIBSC code: 86/680).
IL-4 GMP-11846-HNAE DMF备案 ≥95% E. coli Cell proliferation assay using TF‑1 human erythroleukemic cells. The ED50 for this effect is 0.05-0.25 ng/mL. The specific activity of recombinant human IL-4 is >10,000 IU/μg which is calibrated against the human IL-4 WHO International Standard (NIBSC code: 88/656).
IL-15 GMP-10360-HNAE DMF备案 ≥95% E. coli Measured in a cell proliferation assay using MO7e human megakaryocytic leukemic cells. The ED50 for this effect is typically 3-12 ng/mL.
IL15 GMP-10360-HNCE ≥ 95 % E. coli Cell proliferation assay using MO7e human megakaryocytic leukemic cells. The ED50 for this effect is typically 0.5-5 ng/mL.
IFN-γ GMP-11725-HNAE ≥95% E. coli Measured in anti-viral assays using WISH cells infected with vesicular stomatitisvirus (VSV). The ED50 for this effect is 8-80 pg/mL.
OSM GMP-10452-HNAH ≥95% HEK293 Cells Measured in a cell proliferation assay using TF-1 human erythroleukemic cells.The ED50 for this effect is typically 0.3-1.2 ng/mL.The specific activity of recombinant human OSM is >30,000 Units/μg, which is calibrated against the human OSM WHO International Standard (NIBSC code: 93/564).
IL12 GMP-CT011-H08H ≥ 95 % HEK293 Cells Induced Interferon gamma secretion by human natural killer lymphoma NK-92 cells. The ED50 for this effect is typically 0.04-0.4 ng/mL. The specific activity of recombinant human IL-12 is >10,000 Units/μg, , which is calibrated against the human IL-12 WHO International Standard (NIBSC code: 95/544).
Activin A GMP-10429-HNAH ≥ 95 % HEK293 Cells Inhibited proliferation of MPC-11 cells. The ED50 for this effect is 0.5-5ng/mL. The specific activity of recombinant human Activin A is >1,000U/mg, which is calibrated against the human Activin A International Standard (NIBSC code: 91/626).
GM-CSF/CSF2 GMP-10015-HNAH ≥ 95 % HEK293 Cells Cell proliferation assay using TF-1 human erythroleukemic cells. The ED50 for this effect is typically 0.06-0.3 ng/mL.
IL3 GMP-11858-HNAE ≥ 95 % E. coli Cell proliferation assay using TF-1 human erythroleukemic cells. The ED50 for this effect is typically 0.15-0.75 ng/mL.
FGF10 GMP-10573-HNAE ≥ 95 % E. coli Cell proliferation assay using BaF3 mouse pro-B cells transfected with human FGFR2b. The ED50 for this effect is typically 3-30 ng/mL.
EGF GMP-10605-HNAE ≥ 95 % E. coli The specific activity of human EGF is >1,000 x IU/μg, which is calibrated against the human EGF WHO International Standard (NIBSC code: 91/530).
FGF2 GMP-10014-HNAE ≥ 95 % E. coli Cell proliferation assay using Balb/c 3T3 mouse embryonic fibroblasts. The ED50 for this effect is typically 0.01-0.1 ng/mL. The specific activity of human FGF basic/FGF2 GMP is >1,000 IU/μg, which is calibrated against the human FGF basic/FGF2 WHO International Standard (NIBSC code: 90/712).

【注：义翘神州销售的GMP级产品仅供科研或生产使用，不可直接应用于人体】

更多细胞因子产品

类器官培养细胞因子   FGF 家族及受体   Gamma-Chain 细胞因子   VEGFs 及受体   IL-12 家族
 
IL-10 家族 IL-1 家族 集落刺激因子 （CSFs） I型干扰素因子 （Type I IFN） IL-13
 
IL-21 IL-17 IL-18 IL-1β

细胞因子检测试剂盒产品

基于成熟的重组蛋白平台、抗体技术平台和质量控制平台，义翘神州开发了多种ELISA 细胞因子定量检测试剂盒产品，可用于准确定量检测血浆、血清、细胞培养上清液和其他生物样本中的细胞因子。

货号 检测靶点 靶点种属 样品类型
KIT50114 IL1A Mouse S (Serum); C (Cell culture supernatant)
KIT11848 IL2 Human S, C, P (Plasma)
KIT11846 IL4 Human C
KIT15673 IL5 Human C
KIT10395A IL6 Human S, C
KIT10098 IL8 Human C
KIT10947A IL10 Human C
KIT12047 IL17A Human C
KIT51065 IL17A Mouse C
KIT10119 IL18 Human S
货号 检测靶点 靶点种属 样品类型
KIT50073 IL18 Mouse S
KIT10602 TNFα Human C
KIT11725A IFNγ Human C
KIT10134 CCL2 Human S, U (Urine)
KIT50368 CCL2 Mouse C
KIT10233 CCL17 Human S
KIT10015 GM-CSF Human C
KIT51048 GM-CSF Mouse S, C
KIT11792 M-CSF Human S, C, U
KIT11050 NGF Human C

另有ELISA pair set产品可供选择：

货号 检测靶点 靶点种属
SEK50114 IL1A Mouse
SEKA15673 IL5 Human
SEKB10395 IL6 Human
SEK10098 IL8 Human
SEKA10947 IL10 Human
SEK12047 IL17A Human
SEK51065 IL17A Mouse
SEK10119 IL18 Human
SEK50073 IL18 Mouse
SEKA10602 TNFα Human
SEK50349 TNFα Mouse
货号 检测靶点 靶点种属
SEK60002 TNFα Ferret
SEKA11725 IFNγ Human
SEK10134 CCL2 Human
SEK50368 CCL2 Mouse
SEK10233 CCL17 Human
SEK10007 G-CSF Human
SEK10015 GM-CSF Human
SEK51048 GM-CSF Mouse
SEK11792 M-CSF Human
SEK11050 NGF Human
SEK10368 IL33 Human
请从上面列表中查询所需产品，并联系我们：
北京义翘神州科技股份有限公司

电话：400-890-9989
邮箱：marketing@sinobiological.cn
官网：cn.sinobiological.com
地址：北京市北京经济技术开发区科创十街18号院9号楼

北京义翘神州
关注"义翘神州"
获取更多资讯与促销信息