GMP Human TNF-alpha Protein
Catalog # GMP-TNAH23

Features

Sterility

Designed under ISO 9001:2015 and ISO 13485:2016
Manufactured and QC tested under a GMP compliance factory
Animal-Free materials
Beta-lactam materials free

The sterility testing was performed by membrane filtration method described in
CP<1101>, USP<71> and Eur. Ph. 2.6.1.

Mycoplasma
Negative.

PurityBatch-to-batch consistency
Stringent quality control tests>95% as determined by SDS-PAGE.
>95% as determined by SEC-HPLC.

SourceGMP Human TNF-alpha Protein(GMP-TNAH23) is expressed from human 293cells (HEK293). It contains AA Val 77 - Leu 233 (Accession # P01375).
Predicted N-terminus: Val 77

Molecular Characterization

Formulation
Lyophilized from 0.22 μm filtered solution in PBS, pH7.4 with protectants.
Contact us for customized product form or formulation.

Shipping
This product is supplied and shipped with blue ice, please inquire the shipping
cost.
This protein carries no "tag".
The protein has a calculated MW of 17.4 kDa. The protein migrates as 17 kDa±3
kDa under reducing (R) condition (SDS-PAGE) due to glycosylation.

StorageUpon receipt, store it immediately at -20°C or lower for long term storage.
Please avoid repeated freeze-thaw cycles.

Endotoxin
Less than 10 EU/mg by the LAL method.

Host Cell Protein

This product is stable after storage at:-20°C to -70°C for 5 years in lyophilized state;-70°C for 12 months under sterile conditions after reconstitution.

<0.5 ng/µg of protein tested by ELISA.

Host Cell DNA<0.02 ng/μg of protein tested by qPCR.

SDS-PAGE

SEC-HPLC

GMP Human TNF-alpha Protein on SDS-PAGE under reducing (R) condition.

The purity of GMP Human TNF-alpha Protein (Cat. No. GMP-TNAH23) wasThe gel was stained with Coomassie Blue. The purity of the protein is greater

greater than 95% as determined by SEC-HPLC.

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9/18/2024

GMP Human TNF-alpha Protein
Catalog # GMP-TNAH23

than 95%.

Bioactivity-Bioactivity CELL BASE

GMP Human TNF-alpha Protein (Cat. No. GMP-TNAH23) induces
cytotoxicity effect on the WEHI-13VAR cells in the presence of the metabolic
inhibitor actinomycin D. The specific activity GMP Human TNF-alpha Protein(Cat. No. GMP-TNAH23) is ≥ 2.00×10^7 IU/mg, which is calibrated against

The activity of GMP Human TNF-alpha Protein (Cat. No. GMP-TNAH23) was
consistent with competing products.

human TNF-alpha WHO International Standard (NIBSC code: 12/154) (QCtested).

Bioactivity-Stability

The Cell based assay shows that GMP Human TNF-alpha Protein (Cat. No.
GMP-TNAH23) is stable at 37 ℃ for 24 hours.

The Cell based assay shows that GMP Human TNF-alpha Protein (Cat. No.
GMP-TNAH23) is stable after freezing and thawing 3 times.

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9/18/2024

GMP Human TNF-alpha Protein
Catalog # GMP-TNAH23

The Cell based assay shows that GMP Human TNF-alpha Protein (Cat. No.

The Cell based assay shows batch-to-batch consistency between Acro's GMPGMP-TNAH23) is stable at 4 ℃ for 180 days.

and PG TNF-alpha.

MANUFACTURING SPECIFICATIONSACROBiosystems GMP grade products are produced under a quality management system and in compliance with relevant guidelines: Ph. Eur General Chapter
5.2.12 Raw materials of biological origin for the production of cell-based and gene therapy medicinal products; USP<92>Growth Factors and Cytokines Used in Cell
Therapy Manufacturing; USP<1043>Ancillary Materials for Cell, Gene, and Tissue-Engineered Products; ISO/TS 20399-1:2018, Biotechnology - Ancillary
Materials Present During the Production of Cellular Therapeutic Products.

ACROBiosystems Quality Management System Contents：
Designed under ISO 9001:2015 and ISO 13485:2016, Manufactured and QC tested under a GMP compliance factory.
Animal-Free materials
Materials purchased from the approved suppliers by QA
ISO 5 clean rooms and automatic filling equipment
Qualified personnel
Quality-related documents review and approve by QA
Fully batch production and control records
Equipment maintenance and calibration
Validation of analytical procedures
Stability studies conducted
Comprehensive regulatory support files
Request For Regulatory Support Files（RSF）

ACROBiosystems provide rigorous quality control tests (fully validated equipment, processes and test methods) on our GMP grade products to ensure that they meetstringent standards in terms of purity, safety, activity and inter-batch stability, and each bulk QC lot mainly contains the following specific information:
SDS-PAGE
Protein content
Endotoxin level
Residual Host Cell DNA content
Residual Host Cell Protein content
Biological activity analysisMicrobial testing
Mycoplasma testingIn vitro virus assay
Residual moisture
Batch-to-batch consistencywww.acrobiosystems.com

9/18/2024

GMP Human TNF-alpha Protein
Catalog # GMP-TNAH23

Background
Tumor necrosis factor alpha (TNFα) is a cytokine produced primarily by monocytes and macrophages. It is found in synovial cells and macrophages in thetissues.The primary role of TNFα is in the regulation of immune cells. TNFα is able to induce apoptotic cell death, to induce inflammation, and to inhibit
tumorigenesis and viral replication. Dysregulation of TNFα production has been implicated in a variety of human diseases, including major depression, Alzheimers
disease and cancer. Recombinant TNFα is used as an immunostimulant under the INN tasonermin. TNFα can be produced ectopically in the setting of malignancy
and parallels parathyroid hormone both in causing secondary hypercalcemia and in the cancers with which excessive production is associated.

Clinical and Translational Updates

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9/18/2024