Human GM-CSF Protein, premium grade
Features and Advantages
1. Seamless Transition from Preclinical to Clinical: Same cell clone, process, and QC as GMP products.
2. Enhanced Production Standards: AOF raw materials, pharma-grade excipients, Grade B+A (ISO 5) environment.
3. Comprehensive Quality Control: Additional strict testing for process impurities, sterility, and mycoplasma.
4. Cost-Effective Solution: GMP-comparable quality at an economical price for early development.
5. Risk Mitigation: Enhanced safety through rigorous impurity control and comprehensive testing.
Synonym
GM-CSF, CSF2, MGC131935
Source
Human GM-CSF, premium grade (GMF-H4214) is expressed from human 293 cells (HEK293). It contains AA Ala 18 - Glu 144 (Accession # NP_000749.2).
Predicted N-terminus: Ala 18
It is produced under our rigorous quality control system that incorporates a comprehensive set of tests including sterility and endotoxin tests. Product performance is carefully validated and tested for compatibility for cell culture use or any other applications in the early preclinical stage.
GMP-GMFH28 is the GMP version of this GMF-H4214. These two proteins display indistinguishable performance profiles, thereby ensuring a seamless transition for end users from early preclinical stage to later clinical phases.
Molecular Characterization
This protein carries no "tag".
The protein has a calculated MW of 14.5 kDa. The protein migrates as 25 kDa±3 kDa when calibrated against Star Ribbon Pre-stained Protein Marker under reducing (R) condition (SDS-PAGE) due to glycosylation.
Endotoxin
Less than 0.01 EU per μg by the LAL method / rFC method.
Host Cell Protein
<0.5 ng/µg of protein tested by ELISA.
Host Cell DNA
<0.02 ng/μg of protein tested by qPCR.
Sterility
Negative
Mycoplasma
Negative
Purity
>95% as determined by SDS-PAGE.
>95% as determined by SEC-MALS.
Formulation
Lyophilized from 0.22 μm filtered solution in PBS, pH7.4 with trehalose as protectant.
Contact us for customized product form or formulation.
Reconstitution
Please see Certificate of Analysis for specific instructions.
For best performance, we strongly recommend you to follow the reconstitution protocol provided in the CoA.
Storage
For long term storage, the product should be stored at lyophilized state at -20°C or lower.
Please avoid repeated freeze-thaw cycles.
This product is stable after storage at:
-20°C to -70°C for 24 months in lyophilized state;
-70°C for 3 months under sterile conditions after reconstitution.
Quality Description
ACRO's Research-grade products are suitable for a wide range of cell culture applications, particularly for research use in academic institutions. These products are sterilized by filtration before lyophilization. Typical specifications include endotoxin levels of <0.01 EU/μg and purities >95%. Biological activity is calibrated against WHO/NIBSC standards when available.
ACRO's Premium-grade (Pre-GMP) products are characterized by their high quality and enhanced safety profiles, making them ideal for early-stage discovery and manufacturing processes in cell therapy companies. A key advantage is their seamless transition to corresponding GMP-grade versions. Biological activity is calibrated against WHO/NIBSC standards when available. Typical specifications include endotoxin levels of <0.01 EU/μg and purities >95%. In addition, rigorous testing is conducted to ensure the absence of mycoplasma, HCD, and HCP, thereby guaranteeing product safety.
Background
Granulocyte-macrophage colony-stimulating factor (GM-CSF) is also known as Colony stimulating factor 2 (granulocyte-macrophage), is a cytokine initially characterized by its ability to induce colonies of granulocytes and macrophages from myeloid progenitor cells, and is secreted by macrophages, T cells, mast cells, endothelial cells and fibroblasts. GM-CSF is a cytokine that functions as a white blood cell growth factor. GM-CSF stimulates stem cells to produce granulocytes (neutrophils, eosinophils, and basophils) and monocytes. Monocytes exitthe circulation and migrate into tissue, whereupon they mature into macrophages and dendritic cells. Thus, it is part of the immune/inflammatory cascade, by which activation of a small number of macrophages can rapidly lead to an increase in their numbers, a process crucial for fighting infection. The active form of the protein is found extracellularly as a homodimer. Human GM-CSF glycosylated in its mature form. As a part of the immune/inflammatory cascade, GM-CSF promotes Th1 biased immune response, angiogenesis, allergic inflammation, and the development of autoimmunity, and thus worthy of consideration for therapeutic target. GM-CSF has also recently been evaluated in clinical trials for its potential as a vaccine adjuvant in HIV-infected patients. The preliminary results have been promising. GM-CSF is also used as a medication to stimulate the production of white blood cells following chemotherapy.
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