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GMP Human TNF-alpha Protein

フォーカス製品一覧:
PG version TNA-H4211 is now available for seamless transition.
  • Features
    1. Designed under ISO 9001:2015 and ISO 13485:2016

    2. Manufactured and QC tested under a GMP compliance factory

    3. Animal-Free materials

    4. Beta-lactam materials free

    5. Batch-to-batch consistency

    6. Stringent quality control tests

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

    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.

  • Endotoxin
    Less than 10 EU/mg by the LAL 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
    The sterility testing was performed by membrane filtration method described in CP<1101>, USP<71> and Eur. Ph. 2.6.1.
  • Mycoplasma
    Negative.
  • Purity

    >95% as determined by SDS-PAGE.

    >95% as determined by SEC-HPLC.

  • 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.

  • Storage

    Upon receipt, store it immediately at -20°C or lower for long term storage.

    Please avoid repeated freeze-thaw cycles.

    This product is stable after storage at:

    1. -20°C to -70°C for 5 years in lyophilized state;
    2. -70°C for 12 months under sterile conditions after reconstitution.
SDS-PAGE
TNF-alpha SDS-PAGE

GMP Human TNF-alpha Protein on SDS-PAGE under reducing (R) condition. The gel was stained with Coomassie Blue. The purity of the protein is greater than 95%.

SEC-HPLC
TNF-alpha SEC-HPLC

The purity of GMP Human TNF-alpha Protein (Cat. No. GMP-TNAH23) was greater than 95% as determined by SEC-HPLC.

Bioactivity-Bioactivity CELL BASE
 TNF-alpha CELL

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

 TNF-alpha CELL

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

Bioactivity-Stability
 TNF-alpha STABILITY

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

 TNF-alpha STABILITY

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

 TNF-alpha STABILITY

The Cell based assay shows that GMP Human TNF-alpha Protein (Cat. No. GMP-TNAH23) is stable at 4℃ for 30 days.

  • MANUFACTURING SPECIFICATIONS

    ACROBiosystems 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:

    1. Designed under ISO 9001:2015 and ISO 13485:2016, Manufactured and QC tested under a GMP compliance factory.

    2. Animal-Free materials

    3. Materials purchased from the approved suppliers by QA

    4. ISO 5 clean rooms and automatic filling equipment

    5. Qualified personnel

    6. Quality-related documents review and approve by QA

    7. Fully batch production and control records

    8. Equipment maintenance and calibration

    9. Validation of analytical procedures

    10. Stability studies conducted

    11. 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 meet stringent standards in terms of purity, safety, activity and inter-batch stability, and each bulk QC lot mainly contains the following specific information:

    1. SDS-PAGE

    2. Protein content

    3. Endotoxin level

    4. Residual Host Cell DNA content

    5. Residual Host Cell Protein content

    6. Biological activity analysis

    7. Microbial testing

    8. Mycoplasma testing

    9. In vitro virus assay

    10. Residual moisture
    11. Batch-to-batch consistency

  • Background
    Tumor necrosis factor alpha (TNFα) is a cytokine produced primarily by monocytes and macrophages. It is found in synovial cells and macrophages in the tissues.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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