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GMP Human IL-3 Protein

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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. Animal-Free materials

    4. Beta-lactam materials free

    5. Batch-to-batch consistency

    6. Stringent quality control tests

    7. No animal derived peptone and lactose used in production process

  • Source
    GMP Human IL-3 Protein(GMP-L03H18) is expressed from E. coli cells. It contains AA Ala 20 - Phe 152 (Accession # P08700-1).
    Predicted N-terminus: Met
  • Molecular Characterization
    IL-3 Structure

    This protein carries no "tag".

    The protein has a calculated MW of 15.1 kDa. The protein migrates as 14 kDa±3 kDa when calibrated against Star Ribbon Pre-stained Protein Marker under reducing (R) condition (SDS-PAGE).

  • Endotoxin
    Less than 10 EU/mg by the LAL 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 CP<1101>, USP<71> and Eur. Ph. 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.
SDS-PAGE
IL-3 SDS-PAGE

GMP Human IL-3 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-Bioactivity CELL BASE
 IL-3 CELL

GMP Human IL-3 Protein (Cat. No. GMP-L03H18) stimulates proliferation of TF-1 cells. The specific activity of GMP Human IL-3 Protein is > 1.00ⅹ10^6 IU/mg, which is calibrated against human IL-3 WHO International Standard (NIBSC code: 91/510) (QC tested).

 IL-3 CELL

The activity of GMP Human IL-3 (Cat. No. GMP-L03H18) was higher than other competing products.

Application Data
 IL-3 APPLICATION DATA

GMP Human SCF Protein (Cat. No. GMP-SCFH25), Human Flt-3 Ligand Protein (Cat. No. GMP-FLLH28), GMP Human IL-3 Protein (Cat. No. GMP-L03H18) and GMP Human IL-6 Protein (Cat. No. GMP-L06H27) could support the rapid cell expansion and good cell viability of CD34+ hematopoietic stem cells.

Bioactivity-Stability
 IL-3 STABILITY

The Cell based assay shows that GMP Human IL-3 Protein (Cat. No. GMP-L03H18) is stable at 37°C for 24 hours.

 IL-3 STABILITY

The Cell based assay shows that GMP Human IL-3 Protein (Cat. No. GMP-L03H18) is stable after freezing and thawing 3 times.

 IL-3 STABILITY

The Cell based assay shows that GMP Human IL-3 Protein(Cat. No. GMP-L03H18) is stable at 4℃ for 30 days.

 IL-3 STABILITY

The Cell based assay shows batch-to-batch consistency between Acro's GMP and PG IL-3.

  • 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-3 (IL-3) is an interleukin, a type of biological signal (cytokine) which is encoded by the IL-3 gene located on chromosome 5 and produced primarily by activated T cells beside human thymic epithelial cells, activated murine mast cells, murine keratinocytes and neurons/astrocytes. The protein acts in hematopoiesis by controlling the production, differentiation, and function of 2 related white cell populations of the blood, the granulocytes and the monocytes-macrophages. The human IL-3 reported to be a monomer, as it is known, contains 133 amino acids residues which is a single non-glycosylated polypeptide. Specifically, human and murine IL-3 share low homology and it does not show activity on murine cells.
  • Clinical and Translational Updates

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