Cat Number: GMP-102-03

rHuGM-CSF GMP

Inquiry

Source

Escherichia coli

Purity

> 98% by SDS-PAGE and HPLC analyses.

Molecular Weight

Approximately 14.5 kDa, a single non-glycosylated polypeptide chain containing 127 amino acids.

Sequence

APARSPSPST QPWEHVNAIQ EARRLLNLSR DTAAEMNETV EVISEMFDLQ EPTCLQTRLE LYKQGLRGSL TKLKGPLTMM ASHYKQHCPP TPETSCATQI ITFESFKENL KDFLLVIPFD CWEPVQE

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).

Appearance

Sterile filtered white lyophilized (freeze-dried) powder.

Formulation

Lyophilized from a 0.2 μm filtered concentrated solution in PBS, pH 7.4.

Stability & Storage

Use a manual defrost freezer and avoid repeated freeze-thaw cycles.
- A minimum of 12 months from date of receipt, when stored at ≤ -20 °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.
- Refer to lot-specific CoA for the Expiry Date.

Shipping

The product is shipped with polar packs. Upon receipt, store it immediately at the temperature recommended below.

Endotoxin

Less than 0.01 EU/μg of rHuGM-CSF GMP as determined by LAL method.

Host Cell Protein

Less than 0.05% when tested by ELISA.

Host Cell DNA

Less than 20 ng/mg when tested by qPCR.

Reconstitution

Prior to opening, it is recommended to centrifuge the vial briefly to bring the contents down the bottom. Reconstitute in sterile distilled water or aqueous buffer containing 0.1% BSA to a concentration of 0.1-1.0 mg/mL. If animal-origin-free condition is expected in your product, then sterile distilled water is recommended. Stock solutions should be apportioned into working aliquots and stored at ≤ -20 °C. Further dilutions should be made in appropriate buffered solutions.

Usage

This material is offered by Shanghai PrimeGene Bio-Tech for research, laboratory, or further evaluation purposes. NOT FOR HUMAN USE.

Quality Statement

The manufacturing and testing of these products comply with ICH Q7 guidelines.

Sterility

Negative

Mycoplasma

Negative

In Vitro Virus Assay

Negative

Standard

5μg, 100μg

Background

Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) is secreted by a number of different cell types (including activated T cells, B cells, macrophages, mast cells, endothelial cells and fibroblasts) in response to cytokine or immune and inflammatory stimulation. It was initially characterized as a growth factor that can support the in vitro colony formation of granulocyte-macrophage progenitors and has functions of stimulates the growth and differentiation of hematopoietic precursor cells from various lineages. GM-CSF has also been reported to have a functional role on non-hematopoietic cells and can induce human endothelial cells to migrate and proliferate. Additionally, it can stimulate the proliferation of a number of tumor cell lines, including osteogenic sarcoma, carcinoma and adenocarcinoma cell lines. Human GM-CSF shares 54% sequences identity with mouse GM-CSF, but has no biological effects across species. GM-CSF is used as a medication to stimulate the production of white blood cells following chemotherapy and has also recently been evaluated in clinical trials for its potential as a vaccine adjuvant in HIV-infected patients