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主营:分子类,蛋白类,抗体类,生化类试剂
℡ 4000-520-616
℡ 4000-520-616
CellGenix/CellGenix® rh IL-4/50µg/1003-050
产品编号:1003-050
市  场 价:¥0.00
场      地:美国(厂家直采)
联系QQ:1570468124
电话号码:4000-520-616
邮      箱: info@ebiomall.com
美  元  价:待定
品      牌: CellGenix
公      司:CellGenix
公司分类:
CellGenix/CellGenix® rh IL-4/50µg/1003-050
商品介绍

Technical Details

Source
Expressed in E. coli
Description

Human Interleukin-4, accession # P05112, His25-Ser153

Formulation

Lyophilized from a 0.2 µm-filtered solution containing 1.5 mM potassium phosphate, 8.1 mM sodium phosphate, 2.7 mM potassium chloride and 137 mM sodium chloride, pH 7.5

Both product grades are produced under the same conditions in a GMP facility, ensuring an equal product quality and performance. We offer a more comprehensive QC testing including tighter specifications and documentation for our GMP products: Preclinical vs GMP.

 PreclinicalGMP
Molecular weight15.1 kDa15.1 kDa
Purity≥ 95% as determined by SDS-PAGE≥ 97% as determined by SDS-PAGE
Activity≥ 6 x 106 IU/mg, calibrated against NIBSC #88/656 Measured in a cell proliferation assay using an IL-4-dependent cell line, TF18 – 14 x 106 IU/mg, calibrated against NIBSC #88/656 Measured in a cell proliferation assay using an IL-4-dependent cell line, TF1

Batch specific activity on CoA

Endotoxin level< 1000 EU/mg≤ 50 EU/mg
Intended useIntended for preclinical ex vivo use. Not intended for therapeutic use.Intended for clinical ex vivo use. Not intended for human in vivo application.

Handling Instructions

Reconstitution

Recommended in sterile water to a final concentration of 250 µg/ml for 50 µg vials or 500 µg/ml for 1 mg vials.

Shipment

Ambient temperature. Please refer to Technote to learn more about our shipment validation procedure.

Expiry

≥ 6 months from date of shipping. Please refer to Certificate of Analysis for the exact expiry date.

Storage & Stability

Store lyophilized cytokine at -20°C to -80°C.

Store a 250 µg/ml reconstituted cytokine solution:

• 4 weeks at 2°C to 8°C under sterile conditions after reconstitution. Store in the original container. 

• 4 months at -20°C to -80°C under sterile conditions after reconstitution. Store in 60 µl aliquots in polypropylene cryogenic vials.

Avoid repeated freeze/thaw cycles.

Documents

  • Data Sheet: GMP or Preclinical
  • Material Safety Data Sheet: MSDS
  • Certificate of Analysis
  • Technote: ADCF and Serum-free Policy
  • Technote: Batch-to-Batch Consistency of CellGenix® GMP Cytokines
  • Technote: Stability of CellGenix® GMP Cytokines after Reconstitution
  • Technote: Shipment of CellGenix® Preclinical and GMP Cytokines at Ambient Temperatures
  • Technote: CellGenix® rh Cytokines - Preclinical vs GMP
  • More information under Resources

Data

CellGenix GMP rh IL-4 has an activity of 8 – 14 × 106 IU/mg

The activity of GMP rh IL-4 was measured in a cell proliferation assay using the IL-4-dependent cell line TF1. It was calibrated against NIBSC #88/656.

You can find the batch specific activity on the certificate of analysis (CoA).

Regulatory Support

We offer the following to assist you with your regulatory approval process:

  • Comprehensive documentation (e.g. DMFs, Regulatory Support Files, Certificates of Origin)
  • Outstanding QC support (e.g. extensive stability data)
  • The possibility to audit our production site
  • Detailed batch specific test results on our Certificates of Analysis
  • Change notifications prior to relevant changes

Customized solutions can be provided to meet special compliance needs. Contact our Regulatory Support Team for all your regulatory requests & questions:

Phone:     +49 761 88 88 9-302 Email:      regulatorysupport@cellgenix.com

In order to stay up-to-date and help improve regulatory guidance we are actively involved in many of the regulatory initiatives and discussions. We were amongst others actively involved in the discussions for the setup of Ph. Eur. General Chapter 5.2.12 and the ISO Technical Standard 20399.

Regulatory Resources

  • TSE certificate (available on request)
  • Regulatory Support File (available on request)
  • Request a DMF Letter of Authorization (USA only)

Publications

  • The importance of material selection in the differentiation of monocytes into dendritic cellsBoghosian et al., 2018, Cell & Gene Therapy Insights
  • Autologous tolerogenic dendritic cells for rheumatoid and inflammatory arthritisBell, GM. Et al., 2017, Annals of the Rheumatic Diseases
  • Autocrine CCL19 blocks dendritic cell migration toward weak gradients of CCL21Hansen, M. et al., 2016, Cytotherapy
  • Tumor antigen–specific T cells for immune monitoring of dendritic cell–treated glioblastoma patientsMüller, I. et al., 2016, Cytotherapy
  • Survivin and PSMA Loaded Dendritic Cell Vaccine for the Treatment of Prostate CancerXi, HB. et al., 2015, Biological & Pharmaceutical Bulletin
  • Necrotic cell-derived high mobility group box 1 attracts antigen-presenting cells but inhibits hepatocyte growth factor-mediated tropism of mesenchymal stem cells for apoptotic cell deathVogel, S. et al., 2015, Cell Death and Differentiation
  • NF-kB, p38 MAPK, ERK1/2, mTOR, STAT3 and increased glycolysis regulate stability of paricalcitol/dexamethasone-generated tolerogenic dendritic cells in the inflammatory environmentDá?ová, K. et al., 2015, Oncotarget
  • Generation of lentivirus-induced dendritic cells under GMP-compliant conditions for adaptive immune reconstitution against cytomegalovirus after stem cell transplantationSundarasetty, BS. et al., 2015, Journal of Translational Medicine
  • Autologous tumor lysate-pulsed dendritic cell immunotherapy with cytokine-induced killer cells improves survival in gastric and colorectal cancer patientsGao, D. et al., 2014, PLoS One
  • A phase I clinical trial combining dendritic cell vaccination with adoptive T cell transfer in patients with stage IV melanomaPoschke, I. et al., 2014, Cancer Immunology, Immunotherapy
  • Antigen-specific activation and cytokine-faciliated expansion of naive, human CD8+ T cellsWölfl, M., Greenberg, PD., 2014, Nature Protocols
  • TLR4-mediated pro-inflammatory dendritic cell differentiation in humans requires the combined action of MyD88 and TRIFKolanowski, ST. et al., 2014, Innate Immunity
  • Inhibition of TNF receptor signaling by anti-TNF-a biologicals primes naive CD4+ T cells towards IL-10+ T cells with a regulatory phenotype and functionBooks, MA. et al., 2014, Clinical Immunology
  • In-chip fabrication of free-form 3D constructs for directed cell migration analysisOlsen, MH. et al., 2013, Lab on a Chip
  • The natural killer cell response and tumor debulking are associated with prolonged survival in recurrent glioblastoma patients receiving dendritic cells loaded with autologous tumor lysatesPellegatta, S. et al., 2013, Oncoimmunology
  • Comparison of clinical grade type 1 polarized and standard matured dendritic cells for cancer immunotherapyHansen, M. et al., 2013, Vaccine
  • Therapeutic regulation of myeloid-derived suppressor cells and immune response to cancer vaccine in patients with extensive stage small cell lung cancerIclozan, C. et al., 2013, Cancer Immunology, Immunotherapy
  • Melanoma immunotherapy using mature DCs expressing the constitutive proteasomeDanull, J. et al., 2013, The Journal of Clinical Investigation
  • Crosstalk between Toll like receptors and C5a receptor in human monocyte derived DCs suppress inflammatory cytokine produtionZaal, A. et al., 2013, Immunobiology
  • Low-dose temozolomide before dendritic-cell vaccination reduces (specifically) CD4+CD25++Foxp3+ regulatory T-cells in advanced melanoma patientsRidolfi, L. et al., 2013, Journal of Translational Medicine
  • The macrophage mannose receptor promotes uptake of ADAMTS13 by dendritic cellsSorvillo, N. et al., 2012, Blood
  • Myeloid-derived suppressor cells impair the quality of dendritic cell vaccinesPoschke, I. et al., 2012, Cancer Immunology, Immunotherapy
  • Modification of an exposed loop in the C1 domain reduces immune responses to factor VIII in hemophilia A miceWroblewska, A. et al., 2012, Blood
  • Is Anticancer Vaccine Possible: Experimental Application of Produced mRNA Transfected Dendritic Cells Derived from Enriched CD34+ Blood Progenitor CellsLazarova, P. et al., 2012, Immunodeficiency, Chapter 3
  • Complex evaluation of human monocyte-derived dendritic cells for cancer immunotherapyVopenkova, K. et al., 2012, Journal of Cellular and Molecular Medicine
  • Identitiy, potency in vivo viability, and scaling up production of lentiviral vector-induced dendritic cells for melanoma immunotherapyPincha, M. et al., 2012, Human Gene Therapy Methods
  • An optimized method for manufacturing a clinical scale dendritic cell-based vaccine for the treatment of glioblastomaNava, S. et al., 2012, PloS One
  • A phase II study evaluating the safety and efficacy of an adenovirus-DLMP1-LMP2 transduced dendritic cell vaccine in patients with advanced metastatic nasopharyngeal carcinomaChia, WK. et al., 2012, Annals of Oncology
  • Cryopreservation of adenovirus-transfected dendritic cells (DCs) for clinical useGülen, D. et al., 2012, International Immunopharmacology
  • IL-10-generated tolerogenic dendritic cells are optimal for functional regulatory T cell induction – a comparative study of human clinical-applicable DCBoks, MA. et al., 2012, Clinical Immunology
  • HLA-DR-presented peptide-repertoires derived from human monocyte-derived dendritic cells pulsed with blood coagulation factor VIIIvan Haren, SD. et al., 2011, Molecular & Cellular Proteomics
  • Heat-shock protein 70-dependent dendritic cell activation by 5-aminolevulinic acid-mediated photodynamic treatment of human glioblastoma spheroids in vitroEtminan, N. et al., 2011, British Journal of Cancer
  • Prolonged recurrence-free survival following OK432-stimulated dendritic cell transfer into hepatocellular carcinoma during transarterial embolizationNakamato, Y. et al., 2011, Clinical and Experimental Immunology
  • Antigen-Specific B Cells Reactivate an Effective Cytotoxic T Cell Response against Phagocytosed Salmonella through Cross-Presentationde Wit, J. et al., 2010, PLoS One
  • Tumor endothelial marker 8 expression levels in dendritic cell-based cancer vaccines are related to clinical outcomeVenanzi, FM. et al., 2010, Cancer, Immunology, Immunotherapy
  • A pilot study on the immunogenicity of dendritic cell vaccination during adjuvant oyaliplatin/capecitabine chemotherapy in colon cancer patientsLesterhuis, WJ. et al., 2010, British Journal of Cancer
  • Unexpected high response rate to traditional therapy after dendritic cell-based vaccine in advanced melanoma: update of clinical outcome and subgroup analysis)Ridolfi, L. et al., 2010, Clinical and Developmental Immunology
  • Immune suppression by gammadelta T-cells as a potential regulatory mechanism after cancer vaccination with IL-12 secreting dendritic cellsTraxlmayr, MW. et al., 2010, Journal of Immunotherapy
  • Immunogenicity of dendritic cells pulsed with CEA peptide or transfected with CEA mRNA for vaccination of colorectal cancer patientsLesterhuis, WJ. et al., 2010, Anticancer Research
  • Dendritic cell-based vaccination of patients with advanced melanoma: update of clinical outcomeRidolfi, L. et al., 2010, Clinical and Developmental Immunology
  • Autologous dendritic cell vaccine for chronic hepatitis B carriers: a pilot, open label, clinical trial in human volunteersLuo, J. et al., 2010, Vaccine
  • Vaccination with autologous dendritic cells pulsed with multiple tumor antigens for treatment of patients with malignant melanoma: results from a phase I/II trialTrepiakas, R. et al., 2010, Cytotherapy
  • CD40 ligand-triggered human dendritic cells mount interleukin-23 responses that are further enhanced by danger signalsSender, LY. et al., 2010, Molecular Immunology
  • Monophosphoryl lipid A plus IFN gamma maturation of dendritic cells induces antigen-specific CD8+ cytotoxic cells with high cytolytic potentialten Brinke, A. et al., 2010, Cancer Immunology, Immunotherapy
  • Development of a potency assay for human dendritic cells: IL-12p70 productionButterfield, LH. et al., 2008, Journal of Immunotherapy
品牌介绍

CellGenix质量


凭借超过25年的经验,我们是GMP制造细胞和基因治疗领域原材料的专家。

CellGenix是欧洲第一家获得用于治疗性细胞加工的GMP制造授权的公司。自己作为ATMP制造商,使我们获得了深入的细胞培养知识和卓越的法规专业知识。凭借这种独特的背景,我们了解您在产品开发和法规批准过程中面临的高要求。我们可以通过提供专业的技术和法规支持来帮助您简化原材料的鉴定和验证工作。 


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