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Your Position: Home > Protein > IL-7 > GMP-L07H24GB01

CytoPak GMP Human IL-7 Protein

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IL-7 PRODUCT SHOW

CytoPak GMP Human IL-7 Protein is packaged in sterile closed containers that can be readily incorporated into ex vivo clinical production processes. The bag utilizes medical grade multilayer film with two weldable options. The outlet weldable tube contains a proximal TPE section (1/8’’ ID x 1/4’’ OD) and a distal PVC section (3/32’’ ID x 5/32’’ OD). The liquid state and closed-system packaging of CytoPak GMP Human IL-7 Protein can be directly welded to GMP media bags resulting in safety and user-friendliness by bypassing the reconstitution step during manufacture.

  • Features
    1. Closed System Process
    2. Minimized Manual Touchpoints
    3. Ready-to-Use Format
    4. Enhanced Efficiency
    5. Weldable Tubing
    6. Designed under ISO 9001:2015 and ISO 13485:2016
    7. Manufactured and QC tested under a GMP compliance factory
    8. Animal-Free materials
    9. Beta-lactam materials free
    10. Batch-to-batch consistency
  • Source
    CytoPak GMP Human IL-7 Protein(GMP-L07H24GB01) 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).

  • Endotoxin
    Less than 1.0 EU/mL 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

    Supplied as 0.2 μm filtered solution in PBS, rHSA, pH7.4 with protectants.

    Contact us for customized product form or formulation.

  • Shipping

    This product is supplied and shipped with dry 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. Can be stored up to 24 months at -20°C;
    2. Can be stored up to 2 weeks at 2-8°C.
Bioactivity-CELL BASE
 IL-7 CELL

CytoPak GMP Human IL-7 Protein (Cat. No.GMP-L07H24GB01) stimulates proliferation of PHA-P-activated human peripheral blood mononuclear cell (PBMC). The specific activity of CytoPak GMP Human IL-7 Protein is > 1.00ⅹ10^8 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. 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. 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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ETA des produits en stock: 2 jours ouvrables

Drug Development Status

  • Number of Launched Drugs:0 Details
  • Number of Drugs in Clinical Trials:2 Details
  • Latest Research Phase:Phase 1 Clinical

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