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Your Position: Home > Protein > FGF-7 > GMP-FG7H35

GMP Human FGF-7 / KGF Protein (CHO)

Premium grade version FG7-H5318 is now available for seamless transition.

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This product is still under development. Please contact us if you have interest in this product. We will accelerate the development process accordingly and reserve this product for you as request.
  • 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 FGF-7 / KGF Protein (CHO)(GMP-FG7H35) is expressed from CHO cells. It contains AA Cys 32 - Thr 194 (Accession # P21781-1).
    Predicted N-terminus: Cys 32
  • Molecular Characterization
    FGF-7 Structure

    This protein carries no "tag".

    The protein has a calculated MW of 18.9 kDa.

  • Endotoxin
    Less than 10 EU/mg by the LAL method / rFC 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 USP<71> and Ph. Eur. 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.
  • 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
    Fibroblast growth factor (FGF) 7 (is also known as Keratinocyte growth factor (KGF)), a member of FGF family, is initially found to be secreted from mesenchymal cells to repair epithelial tissues. As a well-characterized paracrine growth factor for tissue growth and regeneration, fibroblast growth factor 7 (FGF7) is involved in a number of physiological and pathological processes, including lung disease and cancer. The stromal-derived FGFs, such as FGF7 and FGF10, control epithelial cell resident FGFR2IIIb activities, promote net tissue homeostasis, and restraint tumor cells from progression to malignancy.
  • Clinical and Translational Updates

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