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。
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》 |
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 |
|
质量保证管理体系• 专人负责管理人员培训体系 |
产品安全性检测体系• 细菌内毒素＜5-10EU/mg |
质量体系认证 |
近4000㎡ 的超洁净车间
北京义翘神州科技股份有限公司建立了近4000㎡ 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
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 |
| 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。
另有ELISA pair set产品可供选择：
