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Your Position: ホーム > Protein > IL-7 > GMP-L07H24

GMP Human IL-7 ProteinDMF

PG version IL7-H4219 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. FDA DMF filed

    4. Animal-Free materials

    5. Beta-lactam materials free

    6. Batch-to-batch consistency

    7. Stringent quality control tests

  • Source
    GMP Human IL-7 Protein(GMP-L07H24) is expressed from human 293 cells (HEK293). It contains AA Asp 26 - His 177 (Accession # P13232-1).
    Predicted N-terminus: Asp 26
  • Molecular Characterization
    IL-7 Structure

    This protein carries no "tag".

    The protein has a calculated MW of 17.4 kDa. The protein migrates as 23 kDa and 28 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 DNA Fluorescent Staining method.
  • Sterility
    The sterility testing was performed by membrane filtration method described in CP<1101>, USP<71> and Eur. Ph. 2.6.1.
  • Mycoplasma
    Negative.
  • In vitro virus assay
    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
IL-7 SDS-PAGE

GMP Human IL-7 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
 IL-7 CELL

GMP Human IL-7 Protein (Cat. No. GMP-L07H24) stimulates proliferation of PHA-P-activated human peripheral blood mononuclear cell (PBMC). The specific activity of GMP Human IL-7 is > 1.00×10^8 IU/mg, which is calibrated against human IL-7 WHO International Standard (NIBSC code: 90/530) (QC tested).

 IL-7 CELL

The activity of GMP Human IL-7 Protein (Cat. No. GMP-L07H24) was higher than other competing products.

Bioactivity-Stability
 IL-7 STABILITY

The Cell based assay shows that GMP Human IL-7 Protein (Cat. No. GMP-L07H24) is stable at 37°C for 48 hours.

 IL-7 STABILITY

The Cell based assay shows that GMP Human IL-7 Protein (Cat. No. GMP-L07H24) is stable at 4℃ for 6 months in 4℃ real time stability experiment.

 IL-7 STABILITY

The Cell based assay shows that GMP Human IL-7 Protein (Cat. No. GMP-L07H24) is stable after freezing and thawing 3 times.

  • 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
    Interleukin 7 is also known as IL7, IL-7, and is a hematopoietic growth factor secreted by stromal cells in the red marrow and thymus. It is also produced by keratinocytes, dendritic cells, hepatocytes, neurons, and epithelial cells, but is not produced by lymphocytes. IL-7 stimulates the differentiation of multipotent (pluripotent) hematopoietic stem cells into lymphoid progenitor cells, It also stimulates proliferation of all cells in the lymphoid lineage (B cells, T cells and NK cells). It is important for proliferation during certain stages of B-cell maturation, T and NK cell survival, development and homeostasis. IL-7 is a cytokine important for B and T cell development. This cytokine and the hepatocyte growth factor (HGF) form a heterodimer that functions as a pre-pro-B cell growth-stimulating factor. IL-7 binds to the IL-7 receptor, a heterodimer consisting of Interleukin-7 receptor alpha and common gamma chain receptor. Il-7 promotes hematological malignacies (acute lymphoblastic leukemia, T cell lymphoma). Elevated levels of IL-7 have also been detected in the plasma of HIV-infected patients. IL-7 as an immunotherapy agent has been examined in many pre-clinical animal studies and more recently in human clinical trials for various malignancies and during HIV infection. IL-7 could also be beneficial in improving immune recovery after allogenic stem cell transplant.
  • Clinical and Translational Updates

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