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GMP Human DLL4 Protein, Fc Tag DMF

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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

  • Source
    GMP Human DLL4 Protein, Fc Tag(GMP-DL4H28) is expressed from human 293 cells (HEK293). It contains AA Ser 27 - Pro 524 (Accession # NP_061947.1).
    Predicted N-terminus: Ser 27
  • Molecular Characterization
    DLL4 Structure

    This protein carries a human IgG1 Fc tag at the C-terminus.

    The protein has a calculated MW of 80.7 kDa. The protein migrates as 90 kDa±3 kDa under reducing (R) condition (SDS-PAGE) due to glycosylation.

  • Endotoxin
    Less than 10 EU/mg by the LAL method.
  • Protein A
    <5 ppm of protein tested by ELISA.
  • 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
DLL4 SDS-PAGE

GMP Human DLL4 Protein, Fc Tag on SDS-PAGE under reducing (R) condition. The gel was stained with Coomassie Blue. The purity of the protein is greater than 95%.

Bioactivity-SPR
 DLL4 SPR

GMP Human DLL4 Protein, Fc Tag (Cat. No. GMP-DL4H28) captured on Protein A Chip can bind Human NOTCH1 Protein, His Tag, premium grade (Cat. No. NO1-H52H3) with an affinity constant between 1.00 nM - 150 nM as determined in a SPR assay (Biacore 8K) (QC tested).

Application Data
 DLL4 APPLICATION DATA

CD34+ CD45+ hematopoietic cells were seeded on GMP Human DLL4 Protein, Fc Tag (Cat. No. GMP-DL4H28) - coated plates and differentiated for 26 days, then flow cytometry was used to detect the expression of T-cell progenitor markers, CD7 and CD5. GMP Human DLL4 Protein, Fc Tag (Cat. No. GMP-DL4H28) together with other growth factors could induce the formation of CD7+ and CD7+ CD5+ T-cell progenitors. However, the cells cultured without GMP Human DLL4 Protein, Fc Tag (Cat. No. GMP-DL4H28) - coated plates expressed neither CD5 nor CD7.

 DLL4 APPLICATION DATA

The Recombinant Fibronectin fragment, premium grade (Cat. No. FIN-H5116) combined with GMP Human DLL4 Protein, Fc Tag (Cat. No. GMP-DL4H28), GMP Human VCAM-1 Protein, Fc Tag (Cat. No. GMP-VC1H25) coating on the plate could efficiently induce hematopoietic stem cells differentiation to NK cells, with high expression of CD56+ CD3-.

Bioactivity-Stability
 DLL4 STABILITY

The SPR based assay shows that GMP Human DLL4 Protein, Fc Tag (Cat. No. GMP-DL4H28) is stable at 37℃ for 24 hours.

 DLL4 STABILITY

The SPR based assay shows that GMP Human DLL4 Protein, Fc Tag (Cat. No. GMP-DL4H28) 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. Residual moisture
    11. Batch-to-batch consistency

  • Background
    Delta-like protein 4 (DLL4) is also known as Drosophila Delta homolog 4 (Delta4), which contains one DSL domain and eight EGF-like domains. DLL4 is expressed in vascular endothelium. DLL4 is involved in the Notch signaling pathway as Notch ligand, which can activates NOTCH1 and NOTCH4. DLL4 is involved in angiogenesis and negatively regulates endothelial cell proliferation and migration and angiogenic sprouting. DLL4 can bind to Notch-1 and Notch-4.
  • Clinical and Translational Updates

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ETA des produits en stock: 2 jours ouvrables

Price(EUR) : €790.00

Price(EUR) : €3290.00

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Drug Development Status

  • Number of Launched Drugs:0 Details
  • Number of Drugs in Clinical Trials:3 Details
  • Latest Research Phase:Phase 3 Clinical

Datasheet & Documentation

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DMF (Drug Master File)

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