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CellGenix/CellGenix® rh GM-CSF/50µg/1012-050

Technical Details

Source
Expressed in E. coli
Description

Human GM-CSF, accession # P04141, Ala18-Glu144

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 weight14.5 kDa14.5 kDa
Purity≥ 95% as determined by SDS-PAGE≥ 97% as determined by SDS-PAGE
Activity≥ 6 x 106 IU/mg, calibrated against NIBSC #88/646 Measured in a cell proliferation assay using a GM-CSF-dependent cell line, TF18 – 14 x 106 IU/mg, calibrated against NIBSC #88/646 Measured in a cell proliferation assay using a GM-CSF-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 rh GMP GM-CSF has an activity of 8 – 14 × 106 IU/mg

The activity of rh GMP GM-CSF was measured in a cell proliferation assay using the GM-CSF-dependent cell line TF1. It was calibrated against the NIBSC #88/646.

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
  • Adjuvant dendritic cell vaccination induces tumor-specific immune responses in the majority of stage III melanoma patientsBoudewijns, S. et al., 2016, Oncoimmunology
  • Adaptation to replating of dendritic cells synergizes with Toll-like receptor stimuli and enhances the pro-inflammatory cytokine profileKolanwoski, ST. et al., 2016, Cytotherapy
  • Tumor antigen–specific T cells for immune monitoring of dendritic cell–treated glioblastoma patientsMüller, I. et al., 2016, Cytotherapy
  • 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
  • Long overall, survival after dendritic cell vaccination in metastatic uveal melanoma patientsBol, KF. et al., 2014, American Journal of Ophthalmology
  • TLR4-mediated pro-inflammatory dendritic cell differentiation in humans requires the combined action of MyD88 and TRIFKolanowski, ST. et al., 2014, Innate Immunity
  • Crosstalk between Toll like receptors and C5a receptor in human monocyte derived DCs suppress inflammatory cytokine produtionZaal, A. et al., 2013, Immunobiology
  • Melanoma immunotherapy using mature DCs expressing the constitutive proteasomeDanull, J. et al., 2013, The Journal of Clinical Investigation
  • 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
  • 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
  • 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
  • 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
  • Clinical-Grade Generation of Active NK Cells from Cord Blood Hematopoietic Progenitor Cells for Immunotherapy Using a Closed-System Culture ProcessSpanholtz, J. et al., 2011, 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
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