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Shenandoah CTGrade GMP rh GM-CSF is a recombinant human protein that is produced from E. coli and is designed to support preclinical and clinical research, as well as commercial applications.
High biological activity verified by a relevant bioactivity assay
Low endotoxin levels
≥ 98% purity
High lot-to-lot consistency
Size: 50 µg, 100 µg, and 1 mg. Custom sizes and packaging available on request.
GM-CSF is a hematopoietic growth factor with the ability to form colonies of granulocytes and macrophages.
Enhances the number of circulating white blood cells and function of neutrophils and monocytes
Regulates multiple functions via transcription factors in the differentiated cells, including cell survival, proliferation, and maturation
Generates in vitro murine and human DC populations from bone marrow precursors and blood monocytes, respectively
Human and mouse GM-CSF do not show cross-reactivity
The biological activity of CTGrade GMP interleukins and growth factors is standardized, where applicable, to WHO International standards, providing cell and gene therapy developers consistent, lot-to-lot biological activity and performance.
The CTGrade GMP products are manufactured in a facility that does not use or process beta-lactam containing materials. No animal- or human-derived materials were used during manufacturing or as ingredients. These products are manufactured, tested, and released in an ISO 9001:2015 certified facility following GMP. USP chapter <1043> for ancillary materials has been considered in the manufacture of these products.
SDS-PAGE Showing a Prominent Band at 14.6 kDa
Figure 1. CTGrade GMP rh GM-CSF (1 μg) was resolved with SDS-PAGE under non-reducing (NR) and reducing (R) conditions and visualized by InstantBlue staining showing a single prominent band at 14.6 kDa.
Cell-based Proliferation Assay
Figure 2. The biological activity of CTGrade GMP rh GM-CSF was determined in TF-1 cell-based proliferation assay.
Lot-to-lot Consistency
Figure 3. CTGrade GMP rh GM-CSF induces proliferation of TF-1 cells that is consistent between lots.
Bioactivity Comparison with Commercially-available GMP GM-CSF
Figure 4. Bioactivity comparison between CTGrade GMP rh GM-CSF and commercially-available GMP GM-CSF.
CTGrade GMP rh GM-CSF lyophilized at 1 mg/ml in 10 mM Sodium Phosphate, pH 7.5, 0.2 µm filtered
Protein Purity
≥ 98% determined with Coomassie staining
Endotoxin
< 0.02 EU/µg using USP <85> / EP 2.6.14
Bioactivity
ED50 is determined by the dose-dependent proliferation of TF-1 cells. The ED50 is typically less than 0.2 ng/mL. The international units of CTGrade GMP rh GM-CSF is approximately 1.6 x 104 IU/µg, which is calibrated against recombinant human granulocyte macrophage colony stimulating factor WHO International Standard (NIBSC code 88/646).
Quality
Carrier-free and no animal- or human-derived materials were used during manufacturing
Specifications
Storage
This product is shipped at ambient temperature. Immediately upon receipt, store the lyophilized protein at -20°C in a manual defrost freezer.
Shelf Life
Unopened vials are stable for 36 months from the date of manufacture as indicated on the label. Reconstituted material should be apportioned in working volumes and stored at or below -20°C in manual defrost freezer. For short term storage reconstituted material is stable for 4-6 weeks when stored at 2-8°C. Stability can be increased by adding at least 0.1% carrier protein.
