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GMP Human IL-2 ProteinDMF

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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. FDA DMF filed

    4. Animal-Free materials

    5. Beta-lactam materials free

    6. Batch-to-batch consistency

    7. Stringent quality control tests

    8. No animal derived peptone and lactose used in production process
  • Source
    GMP Human IL-2 Protein(GMP-L02H14) is expressed from E. coli cells. It contains AA Ala 21 - Thr 153 (Accession # P60568-1).
    Predicted N-terminus: Met
  • Molecular Characterization
    IL-2 Structure

    This protein carries no "tag".

    The protein has a calculated MW of 15.4 kDa.

  • Host Cell Protein
    <0.5 ng/µg of protein tested by ELISA.
  • Host Cell DNA
    <0.1 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.
  • Formulation

    Lyophilized from 0.22 μm filtered solution in phosphate 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 for 24 months in lyophilized state;
    2. -70°C for 12 months under sterile conditions after reconstitution.
Bioactivity-Bioactivity CELL BASE
 IL-2 CELL

GMP Human IL-2 Protein (Cat. No. GMP-L02H14) stimulates proliferation of CTLL-2 cells. The specific activity of GMP Human IL-2 Protein is ≥ 1.20×10^7 IU/mg, which is calibrated against human Interleukin-2 China National Standard (NIFDC code: 270008) (QC tested). China National Institutes for Food and Drug Control (NIFDC) Standard was prepared and calibrated against human IL-2 WHO International Standard (NIBSC code: 86/500) by NIFDC.

Bioactivity-Stability
 IL-2 STABILITY

The Cell based assay shows that GMP Human IL-2 Protein (Cat. No. GMP-L02H14) is stable at 37°C for 8 hours.

 IL-2 STABILITY

The Cell based assay shows that GMP Human IL-2 Protein (Cat. No. GMP-L02H14) is stable in the quality of different batches.

  • 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-2 (IL-2) is an interleukin, a type of cytokine immune system signaling molecule, which is a leukocytotrophic hormone that is instrumental in the body's natural response to microbial infection and in discriminating between foreign (non-self) and self. IL-2 mediates its effects by binding to IL-2 receptors, which are expressed by lymphocytes, the cells that are responsible for immunity. Mature human IL-2 shares 56% and 66% aa sequence identity with mouse and rat IL-2, respectively. Human and mouse IL-2 exhibit crossspecies activity. The receptor for IL-2 consists of three subunits that are present on the cell surface in varying preformed complexes. IL-2 is also necessary during T cell development in the thymus for the maturation of a unique subset of T cells that are termed regulatory T cells (T-regs). After exiting from the thymus, T-Regs function to prevent other T cells from recognizing and reacting against "self antigens", which could result in "autoimmunity". T-Regs do so by preventing the responding cells from producing IL-2. Thus, IL-2 is required to discriminate between self and non-self, another one of the unique characteristics of the immune system.
  • Clinical and Translational Updates

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