2022年,國家藥監局發(fā)布公開(kāi)征求《藥品生產(chǎn)質(zhì)量管理規范-細胞治療產(chǎn)品附錄(征求意見(jiàn)稿)》意見(jiàn),對關(guān)鍵物料要求進(jìn)行風(fēng)險評估,以確定關(guān)鍵物料有記錄,如直接用于細胞產(chǎn)品生產(chǎn)的基因修飾載體或其他起始生物材料、細胞因子、生長(cháng)因子、酶、血清等?!吨袊幍洹啡恐小吧镏破飞a(chǎn)用原材料及輔料質(zhì)量控制規程”及國外相關(guān)技術(shù)要求對原材料的風(fēng)險等級進(jìn)行評估并分類(lèi),同一種試劑或材料,優(yōu)先選擇低風(fēng)險級別的,如藥用無(wú)菌制劑優(yōu)于藥用制劑,藥用級優(yōu)先于非藥用級、GMP級優(yōu)先于非GMP級、非動(dòng)物源性?xún)?yōu)先于動(dòng)物源性材料等。
義翹神州致力于開(kāi)發(fā)高質(zhì)量的用于細胞治療研究及臨床的相關(guān)試劑,在擁有GMP質(zhì)量管理體系基礎上,以更完善的質(zhì)量管理和放行檢測標準,成功開(kāi)發(fā)一系列更高質(zhì)量的GMP級細胞因子。另有無(wú)動(dòng)物源細胞因子可供選擇!
質(zhì)量管理體系? 符合《藥品生產(chǎn)質(zhì)量管理規范》 |
質(zhì)量控制體系? 符合《中華人民共和國藥典》2020年版三部通則:生物制品生產(chǎn)用原材料及輔料質(zhì)量控制 |
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質(zhì)量保證管理體系? 專(zhuān)人負責管理人員培訓體系 |
產(chǎn)品安全性檢測體系? 細菌內毒素<5-10EU/mg |
質(zhì)量體系認證 |
北京義翹神州科技股份有限公司建立了近7000㎡ 的超潔凈車(chē)間,擁有原核生產(chǎn)車(chē)間和真核生產(chǎn)車(chē)間,配備先進(jìn)的培養設備和純化設備,做到生產(chǎn)全過(guò)程控制。
反應器 |
純化設備 |
均質(zhì)機 |
Human Interleukin-21 / IL-21 Protein 貨號:GMP-10584-HNAE |
Human IL7 / Interleukin 7 Protein 貨號:GMP-11821-HNAE |
Human IL-1 beta / IL1B Protein 貨號: GMP-10139-HNAE |
Human Interleukin-21 / IL-21 Protein 貨號:GMP-10584-HNAE Induced Interferon gamma secretion by human natural killer lymphoma NK-92 cells |
Human IL7 / Interleukin 7 Protein 貨號:GMP-11821-HNAE Cell proliferation assay using anti-CD3 antibody activated human peripheral blood mononuclear cell (PBMC) |
Human Interleukin-2 / IL-2 Protein 貨號:GMP-11848-HNAE Cell proliferation assay using CTLL2. The specific activity of recombinant human IL-2 is approximately 20,000 IU/μg |
Human Interleukin-21 / IL-21 Protein 貨號:GMP-10584-HNAE Induced Interferon gamma secretion by human natural killer lymphoma NK-92 cells |
Human IL7 / Interleukin 7 Protein 貨號:GMP-11821-HNAE Cell proliferation assay using anti-CD3 antibody activated human peripheral blood mononuclear cell (PBMC) |
細胞因子 | 貨號 | 純度 | 表達宿主 | 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備案 | ≥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備案 | ≥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備案 | ≥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備案 | ≥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備案 | ≥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:義翹神州銷(xiāo)售的GMP級產(chǎn)品僅供科研或生產(chǎn)使用,不可直接應用于人體】
類(lèi)器官培養細胞因子 | FGF 家族及受體 | Gamma-Chain 細胞因子 | VEGFs 及受體 | IL-12 家族 | ||||
IL-10 家族 | IL-1 家族 | 集落刺激因子 (CSFs) | I型干擾素因子 (Type I IFN) | IL-13 | ||||
IL-21 | IL-17 | IL-18 | IL-1β |
基于成熟的重組蛋白平臺、抗體技術(shù)平臺和質(zhì)量控制平臺,義翹神州開(kāi)發(fā)了多種ELISA 細胞因子定量檢測試劑盒產(chǎn)品,可用于準確定量檢測血漿、血清、細胞培養上清液和其他生物樣本中的細胞因子。
另有ELISA pair set產(chǎn)品可供選擇: