| Source: |
Escherichia coli |
| Molecular Weight: |
Approximately 14.5 kDa, a single non-glycosylated polypeptide chain containing 127 amino acids. |
| Purity: |
> 98% by SDS-PAGE and HPLC analyses. |
| Biological Activity: |
Fully biologically active when compared to standard. The ED50 as determined by a cell proliferation assay using human TF-1 cells is less than 0.1 ng/mL, corresponding to a specific activity of > 1.0 × 107 IU/mg, which is calibrated against rHuGM-CSF WHO International Standard (NIBSC code: 88/646). |
| Physical Appearance: |
Sterile filtered white lyophilized (freeze-dried) powder. |
| Formulation: |
Lyophilized from a 0.2 μm filtered concentrated solution in PBS, pH7.4. |
| Endotoxin: |
Less than 0.01 EU/μg of rHuGM-CSF GMP as determined by LAL method. |
| Reconstitution: |
Centrifuge the vial briefly before opening to ensure that the contents settle at the bottom. Reconstitute the vial with sterile distilled water or an aqueous buffer containing 0.1% BSA to achieve a concentration of 0.1-1.0 mg/mL. Divide the resulting stock solution into working aliquots and store them at or below -20°C. For further dilutions, use appropriate buffered solutions. |
| Stability & Storage: |
Use a manual defrost freezer and avoid repeated freeze-thaw cycles.
12 months from date of receipt, -20 to -70°C as supplied.
1 month, 2 to 8°C under sterile conditions after reconstitution.
3 months, -20 to -70°C under sterile conditions after reconstitution. |
| Background: |
The Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) is a secretion from a variety of cell types like activated T cells, B cells, macrophages, mast cells, endothelial cells, and fibroblasts when stimulated by cytokines or immune and inflammatory triggers. GM-CSF was initially identified as a growth factor that can stimulate the formation of granulocyte-macrophage progenitor colonies in vitro and can also promote the maturation of hematopoietic precursor cells from different origins. It has been suggested that GM-CSF may play a role in non-hematopoietic cells by encouraging human endothelial cells to multiply and move. Furthermore, it has been observed to trigger the growth of several tumor cell lines, such as osteogenic sarcoma, carcinoma, and adenocarcinoma. GM-CSF shares 54% of its sequences with its mouse equivalent, but it does not exert any biological effects across different species. It is employed therapeutically to boost white blood cell production post-chemotherapy and is currently undergoing clinical trials for its potential as an adjuvant in HIV vaccines. |
| Shipping: |
The product is shipped with polar packs. Upon receipt, store it immediately at the temperature recommended below. |
| Sequence: |
APARSPSPST QPWEHVNAIQ EARRLLNLSR DTAAEMNETV EVISEMFDLQ EPTCLQTRLE LYKQGLRGSL TKLKGPLTMM ASHYKQHCPP TPETSCATQI ITFESFKENL KDFLLVIPFD CWEPVQE |
| Sterility: |
Negative. |
| Mycoplasma: |
Negative. |
| Host Cell Protein: |
Less than 0.05% when tested by ELISA. |
| Quality Statement: |
The manufacturing and testing of these products comply with ICH Q7 guidelines. |
| Host Cell DNA: |
Less than 20 ng/mg when tested by qPCR. |
| In Vitro Virus Assay: |
Negative. |
