北京義翹神州

細胞因子(cytokine)是一類(lèi)能在細胞間傳遞信息,具有免疫調節和效應功能的低分子量蛋白質(zhì)或小分子多肽,具有促進(jìn)細胞生成和生長(cháng)以及修復損傷組織等功能。細胞因子不僅廣泛用于生命科學(xué)基礎研究領(lǐng)域,還用于腫瘤免疫治療靶點(diǎn)研究,亦可作為培養基補充劑廣泛用于細胞培養過(guò)程。在腫瘤免疫治療、干細胞治療和再生醫學(xué)的研究及生產(chǎn)過(guò)程中,添加細胞因子能夠調節細胞增殖和分化、信號轉導等,細胞因子也被廣泛的用于Car-T細胞的制備和細胞培養等方面。為了確保安全性,對細胞因子有了更高的要求和更嚴格的標準和管理。

GMP級細胞因子是指在生產(chǎn)過(guò)程中按照GMP標準進(jìn)行,有嚴格的質(zhì)量管理體系、規范的質(zhì)量保證管理以及質(zhì)量控制體系,最大限度的降低生產(chǎn)過(guò)程中的差異性和不確定性,確保細胞因子產(chǎn)品的高質(zhì)量。GMP級細胞因子與重組藥物不同,不能直接用于疾病治療,可用于細胞治療的輔助原料,不需要經(jīng)過(guò)藥監局批準,但是在生產(chǎn)過(guò)程中嚴格遵守GMP要求。

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)量管理及質(zhì)量控制體系

質(zhì)量管理體系

? 符合《藥品生產(chǎn)質(zhì)量管理規范》
? 符合ISO 9001:2015和ISO 13485:2016質(zhì)量管理體系
? FDA DMF備案中
? 完整的申報支持文檔(RSF)

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
? 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

質(zhì)量保證管理體系

? 專(zhuān)人負責管理人員培訓體系
? 建立和運行設備維護和校準程序
? 供應商管理體系和原材料管理體系
? 文件體系和記錄管理完全滿(mǎn)足GMP規范要求
? 完整的批生產(chǎn)記錄、批檢驗記錄、分裝記錄等
? 質(zhì)量文件或記錄經(jīng)QA審核和批準

產(chǎn)品安全性檢測體系

? 細菌內毒素<5-10EU/mg
? 宿主蛋白殘留檢測<0.5μg/mg(500ppm)
? 宿主DNA殘留檢測<100pg/mg
? 支原體檢測
? 無(wú)菌檢測
? 外源病毒檢測
? 異常毒性檢測

質(zhì)量體系認證

近7000㎡ 的超潔凈車(chē)間

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

GMP級細胞因子:高純度,高活性,高穩定性,高批間一致性

高純度

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

高活性

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

高穩定性

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

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

高批間一致性

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)

GMP級細胞因子產(chǎn)品信息速覽

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】

更多細胞因子產(chǎn)品

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

細胞因子檢測試劑盒產(chǎn)品

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。

貨號 檢測靶點(diǎn) 靶點(diǎn)種屬 樣品類(lèi)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
貨號 檢測靶點(diǎn) 靶點(diǎn)種屬 樣品類(lèi)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產(chǎn)品可供選擇:

貨號 檢測靶點(diǎn) 靶點(diǎn)種屬
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
貨號 檢測靶點(diǎn) 靶點(diǎn)種屬
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
請從上面列表中查詢(xún)所需產(chǎn)品,并聯(lián)系我們:
北京義翹神州科技股份有限公司

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