Purity
> 98% by SDS-PAGE and HPLC analyses.
Molecular Weight
Approximately 17.5 kDa, a single non-glycosylated polypeptide chain containing 158 amino acids.
Sequence
MVRSSSRTPS DKPVAHVVAN PQAEGQLQWL NRRANALLAN GVELRDNQLV VPSEGLYLIY SQVLFKGQGC PSTHVLLTHT ISRIAVSYQT KVNLLSAIKS PCQRETPEGA EAKPWYEPIY LGGVFQLEKG DRLSAEINRP DYLDFAESGQ VYFGIIAL
Biological Activity
Fully biologically active when compared to standard. The ED50 as determined by a cytotoxicity assay using murine L929 cells is less than 0.05 ng/mL, corresponding to a specific activity of > 2.0 × 107 IU/mg in the presence of actinomycin D, which is calibrated against rHuTNF-α/TNFSF2 WHO International Standard (NIBSC code: 12/154).
Appearance
Sterile filtered white lyophilized (freeze-dried) powder.
Formulation
Lyophilized from a 0.2 μm filtered concentrated solution in 5 mM Na2HPO4, 5 mM NaH2PO4, 10 mM NaCl, pH 7.0.
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 rHuTNF-α/TNFSF2 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.
In Vitro Virus Assay
Negative
Background
Tumor necrosis factor alpha (TNF-α), also called cachectin, is the best-know member of the TNF-family, which can cause cell death. This protein is produced by neutrophils, activated lymphocytes, macrophages, NK cells, LAK cells, astrocytes endothelial cells, smooth muscle cells and some transformed cells. TNF-α occurs as a secreted, soluble form and as a membrane-anchored form, both of which are biologically active. The naturally-occurring form of TNF-α is glycosylated, but non-glycosylated recombinant TNF-α has comparable biological activity. The biologically active native form of TNF-α is reportedly a trimer. Human and murine TNF-α show approximately 79% homology at the amino acid level and cross-reactivity between the two species. Two types of receptors for TNF-α have been described and virtually all cell types studied show the presence of one or both of these receptor types.
