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Your Position: Home > Protein > IL-2 > GMP-L02H14GB01

CytoPak GMP Human IL-2 Protein DMF

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IL-2 PRODUCT SHOW

CytoPak GMP Human IL-2 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-2 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
    11. FDA DMF filed
  • Source
    CytoPak GMP Human IL-2 Protein(GMP-L02H14GB01) 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. The protein migrates as 16 kDa±2 kDa when calibrated against Star Ribbon Pre-stained Protein Marker under reducing (R) condition (SDS-PAGE).

  • Endotoxin
    Less than 5.0 EU/mL by the LAL method / rFC method.
  • Host Cell Protein
    <0.5 ng/µg of protein tested by ELISA.
  • Host Cell DNA
    <0.1 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 phosphate 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 -70°C or lower for long term storage.

    Please avoid repeated freeze-thaw cycles.

    This product is stable after storage at:

    1. -70°C for 24 months;
    2. Can be stored up to 1 month at -20°C;
    3. Can be stored up to 1 week at 2-8°C.
SDS-PAGE
IL-2 SDS-PAGE

CytoPak GMP Human IL-2 Protein on SDS-PAGE under reducing (R) and non-reducing (NR) conditions. The gel was stained with Coomassie Blue. The purity of the protein is greater than 95% (With Star Ribbon Pre-stained Protein Marker).

Bioactivity-CELL BASE
 IL-2 CELL

CytoPak GMP Human IL-2 Protein (Cat. No. GMP-L02H14GB01) stimulates proliferation of CTLL-2 cells. The specific activity of CytoPak GMP Human IL-2 Protein is ≥1.20 x 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 CytoPak GMP Human IL-2 Protein (Cat. No. GMP-L02H14GB01) is stable at 25°C for 65 hours.

 IL-2 STABILITY

The Cell based assay shows that CytoPak GMP Human IL-2 Protein (Cat. No. GMP-L02H14GB01) 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. 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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ETA des produits en stock: 2 jours ouvrables

Drug Development Status

  • Number of Launched Drugs:1 Details
  • Number of Drugs in Clinical Trials:31 Details
  • Latest Research Phase:Approved

Datasheet & Documentation

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