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GMP Human IFN-gamma Protein

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  • 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 IFN-gamma Protein(GMP-IFGH24) is expressed from human 293 cells (HEK293). It contains AA Gln 24 - Gln 166 (Accession # P01579).
    Predicted N-terminus: Gln 24
  • Molecular Characterization
    IFN-gamma Structure

    This protein carries no "tag".

    The protein has a calculated MW of 16.8 kDa. The protein migrates as 15 kDa, 19 kDa and 24 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.

  • 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
IFN-gamma SDS-PAGE

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

Bioactivity-Bioactivity CELL BASE
 IFN-gamma CELL

GMP Human IFN-gamma Protein (Cat. No. GMP-IFGH24) inhibits the proliferation of HT-29 cells. The specific activity of GMP Human IFN-gamma Protein is > 2.00×10^7 IU/mg, which is calibrated against human interferon gamma Standard (NIBSC code: 87/586) (QC tested).

 IFN-gamma CELL

The activity of GMP Human IFN-gamma Protein (Cat. No. GMP-IFGH24) was higher than other competing products.

Bioactivity-Stability
 IFN-gamma STABILITY

The Cell based assay shows that GMP Human IFN-gamma Protein (Cat. No. GMP-IFGH24) is stable at 37°C for 24 hours.

 IFN-gamma STABILITY

The Cell based assay shows that GMP Human IFN-gamma Protein (Cat. No. GMP-IFGH24) is stable after freezing and thawing 3 times.

 IFN-gamma STABILITY

The Cell based assay shows that GMP Human IFN-gamma Protein (Cat. No. GMP-IFGH24) is stable at 4°C for 6 months.

 IFN-gamma STABILITY

The Cell based assay shows batch-to-batch consistency between Acro's GMP and PG IFN-gamma.

  • 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
    Interferon-gamma (IFN-γ/IFNG) is a dimerized soluble cytokine that is the only member of the type II class of interferon. This interferon was originally called macrophage-activating factor, a term now used to describe a larger family of proteins to which IFN-γ belongs. IFN-gamma has been used in a wide variety of clinical indications. Interferon-gamma (IFNgamma) is a central regulator of the immune response and signals via the Janus Activated Kinase (JAK)-Signal Transducer and Activator of Transcription (STAT) pathway. Interferon gamma has broader roles in activation of innate and adaptive immune responses to viruses and tumors, in part through upregulating transcription of genes involved in cell cycle regulation, apoptosis, and antigen processing/presentation. Despite this, rodent and human trophoblast cells show dampened responses to IFNG that reflect the resistance of these cells to IFNG-mediated activation of major histocompatibility complex (MHC) class II transplantation antigen expression.
  • Clinical and Translational Updates

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