Recombinant Human GM-CSF GMP Protein, CF GMP

R&D Systems, part of Bio-Techne | Catalog # 215-GMP

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R&D Systems, part of Bio-Techne
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Key Product Details

Source

E. coli

Accession #

P04141.1

Conjugate

Unconjugated

Applications

Bioactivity

View all GM-CSF Proteins and Enzymes »

Product Specifications

Source

E. coli-derived human GM-CSF protein
Ala18-Glu144
Produced using non-animal reagents in an animal-free laboratory.
Manufactured and tested under cGMP guidelines.

Purity

>97%, by SDS-PAGE under reducing conditions and visualized by silver stain.

Endotoxin Level

<0.10 EU per 1 μg of the protein by the LAL method.

N-terminal Sequence Analysis

Ala-Pro-Ala-Arg-Ser-Pro-Ser-Pro-Ser-Thr

Predicted Molecular Mass

14.5 kDa

SDS-PAGE

14 kDa, reducing conditions

Activity

Measured in a cell proliferation assay using TF-1 human erythroleukemic cells. Kitamura, T. et al. (1989) J. Cell Physiol. 140:323.
The ED50 for this effect is 6-30 pg/mL.
The specific activity of recombinant human GM-CSF is >1.0 x 107 IU/mg, which is calibrated against the human GM-CSF WHO International Standard (NIBSC code: 88/646).

Host Cell Protein

< 0.5 ng per µg of protein when tested by ELISA.

Mycoplasma

Negative for Mycoplasma.

Reviewed Applications

Read 1 review rated 5 using 215-GMP in the following applications:

Scientific Data Images for Recombinant Human GM-CSF GMP Protein, CF

Recombinant Human GM-CSF GMP Protein Bioactivity

Recombinant Human GM-CSF GMP Protein Bioactivity

GMP-grade Recombinant Human GM-CSF (Catalog # 215-GMP) stimulates pro-liferation of TF‑1 human erythroleukemic cell line. The ED50 is 6-30 pg/mL.
Recombinant Human GM-CSF GMP Protein SDS-PAGE

Recombinant Human GM-CSF GMP Protein SDS-PAGE

1 μg/lane of GMP-grade Recombinant Human GM-CSF (Catalog # 215-GMP) was resolved with SDS-PAGE under reducing (R) conditions and visualized by silver staining, showing a single band at 14 kDa.
Recombinant Human GM-CSF GMP Protein Mass Spectrometry

Recombinant Human GM-CSF GMP Protein Mass Spectrometry

MALDI-TOF analysis of GMP-grade Recombinant Human GM-CSF (Catalog # 215-GMP). The major peak corresponds to the calculated molecular mass, 14478 Da. The minor peak at 14673 Da is a matrix-associated artifact of the MALDI-TOF.

Formulation, Preparation and Storage

215-GMP
Formulation Lyophilized from a 0.2 μm filtered solution in PBS.
Reconstitution Reconstitute at 100-200 μg/mL in PBS.
Shipping The product is shipped with polar packs. Upon receipt, store it immediately at the temperature recommended below.
Stability & Storage Use a manual defrost freezer and avoid repeated freeze-thaw cycles.
  • A minimum of 12 months when stored at ≤ -20 °C as supplied. Refer to lot specific COA for the Use by Date.
  • 1 month, 2 to 8 °C under sterile conditions after reconstitution.
  • 3 months, ≤ -20 °C under sterile conditions after reconstitution.

Background: GM-CSF

GM‑CSF was initially characterized as a factor that can support the in vitro colony formation of granulocyte‑macrophage progenitors. It is also a growth factor for erythroid, megakaryocyte, and eosinophil progenitors. GM‑CSF is produced by a number of different cell types (including T cells, B cells, macrophages, mast cells, endothelial cells, fibroblasts, and adipocytes) in response to cytokine or inflammatory stimuli. On mature hematopoietic cells, GM‑CSF is a survival factor for and activates the effector functions of granulocytes, monocytes/macrophages, and eosinophils (1, 2). GM‑CSF promotes a Th1 biased immune response, angiogenesis, allergic inflammation, and the development of autoimmunity (3‑5). It shows clinical effectiveness in ameliorating chemotherapy‑induced neutropenia, and GM‑CSF transfected tumor cells are utilized as cancer vaccines (6, 7). The 22 kDa glycosylated GM‑CSF, similar to IL‑3 and IL‑5, is a cytokine with a core of four bundled
alpha-helices (8‑12). Mature human GM‑CSF shares 63%‑70% amino acid sequence identity with canine, feline, porcine, and rat GM‑CSF and 54% with mouse GM‑CSF. GM‑CSF exerts its biological effects through a heterodimeric receptor complex composed of GM‑CSF R alpha/CD116 and the signal transducing common beta chain (CD131) which is also a component of the high‑affinity receptors for IL‑3 and IL‑5 (13, 14). In addition, GM‑CSF binds a naturally occurring soluble form of GM‑CSF R alpha (15). Human GM‑CSF is active on canine and feline cells but not on murine cells (16‑18).

References

  1. Martinez-Moczygemba, M. and D.P. Huston (2003) J. Allergy Clin. Immunol. 112:653.
  2. Barreda, D.R. et al. (2004) Dev. Comp. Immunol. 28:509.
  3. Eksioglu, E.A. et al. (2007) Exp. Hematol. 35:1163.
  4. Cao, Y. (2007) J. Clin. Invest. 117:2362.
  5. Fleetwood, A.J. et al. (2005) Crit. Rev. Immunol. 25:405.
  6. Heuser, M. et al. (2007) Semin. Hematol. 44:148.
  7. Hege, K.M. et al. (2006) Int. Rev. Immunol. 25:321.
  8. Kaushansky, K. et al. (1992) Biochemistry 31:1881.
  9. Diederichs, K. et al. (1991) Science 254:1779. 
  10. Cantrell, M.A. et al. (1985) Proc. Natl. Acad. Sci. 82:6250.
  11. Lee, F. et al. (1985) Proc. Natl. Acad. Sci. 82:4360.
  12. Wong, G.G. et al. (1985) Science 228:810.
  13. Onetto-Pothier, N. et al. (1990) Blood 75:59.
  14. Hayashida, K. et al. (1990) Proc. Natl. Acad. Sci. 87:9655.
  15. Pelley, J.L. et al. (2007) Exp. Hematol. 35:1483.
  16. Hogge, G.S. et al. (1990) Cancer Gene Ther. 6:26.
  17. Sprague, W.S. et al. (2005) J. Comp. Pathol. 133:136.
  18. Shanafelt, A.B. et al. (1991) J. Biol. Chem. 266:13804.

Long Name

Granulocyte Macrophage Growth Factor

Alternate Names

CSF-2, CSF2, GMCSF, Molgramostim, Sargramostim

Entrez Gene IDs

1437 (Human); 12981 (Mouse); 116630 (Rat); 397208 (Porcine); 403923 (Canine); 493805 (Feline)

Gene Symbol

CSF2

UniProt

P04141.1

Additional GM-CSF Products

Product Documents for Recombinant Human GM-CSF GMP Protein, CF

Product Datasheets

Certificate of Analysis

To download a Certificate of Analysis, please enter a lot number in the search box below.

Note: Certificate of Analysis not available for kit components.

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Manufacturing Specifications

GMP Proteins
R&D Systems, a Bio-Techne Brand's GMP proteins are produced according to relevant sections of the following documents: USP Chapter 1043, Ancillary Materials for Cell, Gene and Tissue-Engineered Products and Eu. Ph. 5.2.12, Raw Materials of Biological Origin for the Production of Cell-based and Gene Therapy Medicinal Products.

R&D Systems' quality focus includes:

  • Designed, manufactured and tested under an ISO 9001:2015 and ISO 13485:2016 certified quality system
  • Documented and controlled manufacturing process
  • Control of documentation and process changes by QA
  • Personnel training programs
  • Raw material inspection and vendor qualification/monitoring program
  • Validated equipment, processes and test methods
  • Equipment calibration and maintenance schedules using a Regulatory Asset Manager
  • Facility/Utilities maintenance, contamination controls, safety and pest control programs
  • Material review process for variances
  • Robust product stability program following relevant ICH guidelines

R&D Systems strives to provide our customers with the analytical characteristics of each product so that customers may determine whether our products are appropriate for their application. Each product is provided with a lot-specific Certificate of Analysis that contains the product's specifications and test results. Quality control testing may include, but is not limited to:

  • N-terminal amino acid analysis
  • SDS-PAGE purity analysis
  • Molecular weight analysis via mass spectrometry
  • Endotoxin assessment per USP <85> and Ph. Eur. 2.6.14 guidelines
  • Bioassay analysis
  • Microbial testing per USP <71> and Ph. Eur. 2.6.1 guidelines
  • Host cell protein assessment
  • Host cell DNA assessment
  • Mycoplasma assessment

Additional testing and documentation requested by the customer can be arranged at an additional cost. 

Production records and facilities are available for examination by appropriate personnel on-site at R&D Systems in Minneapolis and St. Paul, Minnesota USA.

R&D Systems sells GMP grade products for preclinical or clinical ex vivo use. They are not for in vivo use. Please read the following End User Terms prior to using this product.


Animal-Free Manufacturing Conditions
Our dedicated controlled-access animal-free laboratories ensure that at no point in production are the products exposed to potential contamination by animal components or byproducts. Every stage of manufacturing is conducted in compliance with R&D Systems' stringent Standard Operating Procedures (SOPs). Production and purification procedures use equipment and media that are confirmed animal-free.

Production

  • All molecular biology procedures use animal-free media and dedicated labware.
  • Dedicated fermentors are utilized in committed animal-free areas.

Purification

  • Protein purification columns are animal-free.
  • Bulk proteins are filtered using animal-free filters.
  • Purified proteins are stored in animal-free containers.

    Please read our complete Animal-Free Statement

    Product Specific Notices for Recombinant Human GM-CSF GMP Protein, CF

    Full terms and conditions of sale can be found online in the Protein Sciences Segment T&Cs at: Terms & Conditions.

    For preclinical, or clinical ex vivo use

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