ACRO's human TNF-alpha proteins have undergone QC testing at a GMP-compliant facility.
Features
- Designed in accordance with ISO 9001:2015 and ISO 13485:2016 standards
- Manufactured and QC tested in a GMP-compliant facility
- Made with animal-free materials
- Ensures batch-to-batch consistency
- Free from beta-lactam materials
- Subjected to rigorous quality control testing
Source
GMP Human TNF-alpha Protein (Cat. No. GMP-TNAH23) is expressed in human 293 cells (HEK293) and comprises amino acids Val 77 to Leu 233 (Accession # P01375).
Predicted N-terminus: Val 77
Molecular characterization
Image Credit: ACROBiosystems Inc
This protein has no "tag".
It has a calculated molecular weight (MW) of 17.4 kDa and migrates as approximately 17 kDa ± 3 kDa under reducing (R) conditions in SDS-PAGE, attributable to glycosylation.
Endotoxin
The endotoxin level is less than 10 EU/mg, determined by the LAL method.
Host cell protein
<0.5 ng/µg of protein as tested by ELISA.
Host cell DNA
qPCR quantification shows <0.02 ng/μg of protein.
Sterility
Sterility testing uses the membrane filtration method described in CP<1101>, USP<71>, and Eur. Ph. 2.6.1
Mycoplasma
Negative.
Purity
SDS-PAGE and SEC-HPLC show >95% purity.
Formulation
Lyophilized from a 0.22 μm filtered PBS solution at pH 7.4 with protectants.
Shipping
Supplied and shipped with blue ice.
Storage
Store immediately at -20 °C or lower upon receipt for long-term storage.
Avoid repeated freeze-thaw cycles.
This product remains stable under the following conditions:
- In lyophilized state, stable for 5 years when stored at -20 °C to -70 °C
- After reconstitution, stable for 12 months at -70 °C under sterile conditions
ACRO quality management system
- Quality Advantages
- QMS（ISO, GMP）
- Quality Control Process
QC and assay protocol
SDS-PAGE
Image Credit: ACROBiosystems Inc
GMP Human TNF-alpha Protein was analyzed by SDS-PAGE under reducing (R) conditions and stained with Coomassie Blue, revealing a purity greater than 95%.
SEC-HPLC
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SEC-HPLC also confirms that the purity of GMP Human TNF-alpha Protein (Cat. No. GMP-TNAH23) is greater than 95%.
Bioactivity-Bioactivity CELL BASE
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GMP Human TNF-alpha Protein (Cat. No. GMP-TNAH23) induces a cytotoxic effect on WEHI-13VAR cells in the presence of the metabolic inhibitor actinomycin D. The specific activity of GMP Human TNF-alpha Protein (Cat. No. GMP-TNAH23) is ≥2.00 × 107 IU/mg, calibrated against the human TNF-alpha WHO International Standard (NIBSC code: 12/154) (QC tested).
Image Credit: ACROBiosystems Inc
The activity of GMP Human TNF-alpha Protein (Cat. No. GMP-TNAH23) is consistent with that of competing products.
Bioactivity-Stability
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The cell-based assay demonstrates that GMP Human TNF-alpha Protein (Cat. No. GMP-TNAH23) remains stable at 37 °C for 24 hours.
Image Credit: ACROBiosystems Inc
The cell-based assay also shows that GMP Human TNF-alpha Protein (Cat. No. GMP-TNAH23) retains stability after three freeze-thaw cycles.
Image Credit: ACROBiosystems Inc
The cell-based assay demonstrates that GMP Human TNF-alpha Protein (Cat. No. GMP-TNAH23) is stable at 4 ℃ for 180 days.
Image Credit: ACROBiosystems Inc
The cell-based assay demonstrates batch-to-batch consistency between Acro's GMP and PG TNF-alpha.