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Your Position: Home > GMP > IL-7 > GMP-L07H24

GMP Human IL-7 GMP

Recommended Hot Products: GMP Human IL-15 
ACROBiosystems has established the GMP grade facility and strict quality management system to support the clinical study of immune cell therapy. If you have any customized inquiries of GMP products, please click here to leave your message.
    1. Designed under ISO 9001:2015 and ISO 13485:2016

    2. Manufactured and QC tested under a GMP compliance factory

    3. Chemically defined cell culture media, serum free and Xeno free, BSE/TSE free raw materials

    4. Batch-to-batch consistency

    5. Stringent quality control tests

  • Synonym
    IL7,Interleukin-7
  • Source
    GMP Human IL-7 (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
    Online(Asp 26 - His 177) P13232-1

    This protein carries no "tag".

    The protein has a calculated MW of 17.4 kDa. The protein migrates as 26-32 kDa under reducing (R) condition (SDS-PAGE) due to glycosylation.

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

    >95% as determined by SDS-PAGE.

  • 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>.

  • Mycoplasma

    Negative

  • In vitro virus assay

    Negative

  • Formulation

    Lyophilized from 0.22 μm filtered solution in PBS, pH7.4. Normally trehalose is added as protectant before lyophilization.

  • Reconstitution

    Please see Certificate of Analysis for specific instructions.

  • Storage

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

    This product is stable after storage at:

    1. -20°C to -70°C for 24 months in lyophilized state from date of receipt;

    2. -70°C for 12 months under sterile conditions after reconstitution.

SDS-PAGE
GMP Human IL-7 (Cat. No. GMP-L07H24) SDS-PAGE gel

GMP Human IL-7 on SDS-PAGE under reducing (R) condition. The gel was stained overnight with Coomassie Blue. The purity of the protein is greater than 95%.

Bioactivity-Cell based assay
Human FcRn Heterodimer Protein Cell_Base

GMP Human IL-7 (Cat. No. GMP-L07H24) stimulates proliferation of PHA-P-activated human peripheral blood mononuclear cell (PBMC). The EC50 for this effect is 3.821 ng/mL, corresponding to a specific activity of > 1.0 ⅹ10^8 IU/mg, which is calibrated against human IL-7 WHO International Standard (NIBSC code: 90/530) (QC tested).

  • 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. Chemically defined cell culture media, serum free and Xeno free, BSE/TSE free raw 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 (Reference the WHO Human IL-7 (NIBSC code: 90/530) as standard)

    7. Microbial testing

    8. Mycoplasma testing

    9. In vitro virus assay

    10. Residual moisture

    11. Batch-to-batch consistency

  • DISCLAIMER

    ACROBiosystems GMP grade products are designed for research, manufacturing use or ex vivo use. CAUTION: Not intended for human in vivo applications.

  • TERMS AND CONDITIONS

    All products are warranted to meet ACROBiosystems Inc.’s (“ACRO”) published specifications when used under normal laboratory conditions.


    ACRO DOES NOT MAKE ANY OTHER WARRANTY OR REPRESENTATION WHATSOEVER, WHETHER EXPRESS OR IMPLIED, WITH RESPECT TO ITS PRODUCTS.  IN PARTICULAR, ACRO DOES NOT MAKE ANY WARRANTY OF SUITABILITY, NONINFRINGEMENT, MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE.

    NOT WITH STANDING ANY OTHER PROVISIONS OF THESE TERMS AND/OR ANY OTHER AGREEMENT BETWEEN ACRO AND PURCHASER FOR THE PURCAHSE OF THE PRODUCTS, ACRO’S TOTAL LIABILITY TO PURCHASER ARISING FROM OR IN RELATION TO THESE TERMS, AN AGREEMENT BETWEEN THE PARTIES OR THE PRODUCTS, WHETHER ARISING IN CONTRACT, TORT OR OTHERWISE SHALL BE LIMITED TO THE TOTAL AMOUNT PAID BY PURCHASER TO ACRO FOR THE RELEVANT PRODUCTS.  IN NO EVENT WILL ACRO BE LIABLE FOR THE COST OF PROCUREMENT OF SUBSTITUTE GOODS.

  • END USER TERMS OF USE OF PRODUCT

    The following terms are offered to you upon your acceptance of these End User Terms of Use of Product. By using this product, you indicate your acknowledgment and agreement to these End User Terms of Use of Product.  If you do not agree to be bound by and comply with all of the provisions of these End User Terms of Use of Product, you should contact your supplier of the product and make arrangements to return the product.

    The End User is aware that ACROBiosystems Inc. and its affiliate (“ACRO”) sell GMP grade products designed for research, manufacturing use or ex vivo use and not intended for human in vivo applications. The End User further agrees, as a condition of the sales of ACRO’s GMP grade products that: a) the End User will not use this GMP grade product in any procedure wherein the product may be directly or indirectly administered to humans, unless the End User has obtained, or prior to their use will have obtained, an Investigational New Drug (IND) exemption from the FDA and will use the product only in accordance with the protocols of such IND and of the Institutional Review Board overseeing the proposed research, or b) the End User will use the products outside of the United States in accordance with the protocols of research approved by the applicable review board or authorized ethics committee and regulatory agencies to which the End User is subject to  in their territory.

  • 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

      

  • Please contact us via TechSupport@acrobiosystems.com if you have any question on this product.

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