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Your Position: Home > GMP > CD3 > GMP-MC0323

GMP Monoclonal Anti-Human CD3 Antibody (OKT3)

Recommended Hot Products: GMP Human IL-15  GMP Human IL-7 
ACROBiosystems has established the GMP grade facility and strict quality management system to support the clinical study of immune cell therapy. If you have any customized inquiries of GMP products, please click here to leave your message.
    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. Batch-to-batch consistency

    5. Stringent quality control tests

  • Source
    HEK293 cells-expressed human GMP Monoclonal Anti-Human CD3 Antibody (OKT3).
  • Isotype
    Mouse IgG2a/kappa
  • Specificity
    The cross-reactivity with other species has not been tested yet.
  • Purity

    >95% as determined by SDS-PAGE.

  • Endotoxin
    Less than 0.002 EU per μg by the LAL method.
  • Host Cell Protein
    <0.5 ng/μg of protein tested by ELISA.
  • Host Cell Protein
    0.02 ng/μg of protein tested by qPCR method.
  • Sterility
    The sterility testing was performed by Membrane Filtration Method described in CP<1101>.
  • Mycoplasma
    Negative.
  • Formulation

    Supplied as 0.2 μm filtered solution in PBS, pH7.4 with trehalose as protectant.

    Contact us for customized product form or formulation.

  • Shipping

    This product is supplied and shipped as sterile liquid solution with dry ice, please inquire the shipping cost.

  • Storage

    For long term storage, the product should be stored at liquid state at -70°C.

    Please avoid repeated freeze-thaw cycles.

    This product is stable after storage at:

    1. 2-8°C for 12 months under sterile condition;

    2. -70°C for 24 months.

SDS-PAGE
CD3 SDS-PAGE

GMP Monoclonal Anti-Human CD3 Antibody (OKT3) on SDS-PAGE under reducing (R) condition. The gel was stained overnight with Coomassie Blue. The purity of the protein is greater than 95%.

Bioactivity-Bioactivity CELL BASE
 CD3 CELL

GMP Monoclonal Anti-Human CD3 Antibody (OKT3) (GMP-MC0323) stimulates secretion of IL-2 by PBMC stimulated with 10 ng/mL Monoclonal Anti-Human CD28 Antibody, Mouse IgG1. The EC50 for this effect is 0.11 ng/mL (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
    CD3e molecule, epsilon is also known as CD3E, is a T-cell surface single-pass type I membrane glycoprotein. CD3E contains 1 Ig-like (immunoglobulin-like) domain and 1 ITAM domain. CD3E, together with CD3-gamma, CD3-delta and CD3-zeta, and the T-cell receptor alpha/beta and gamma/delta heterodimers, forms the T cell receptor-CD3 complex. This complex plays an important role in coupling antigen recognition to several intracellular signal-transduction pathways. The genes encoding the epsilon, gamma and delta polypeptides are located in the same cluster on chromosome 11. The epsilon polypeptide plays an essential role in T-cell development. CD3E plays an essential role in T-cell development, and defects in CD3E gene cause severe immunodeficiency. CD3E gene has also been linked to a susceptibility to type I diabetes in women. CD3E has been shown to interact with TOP2B, CD3EAP and NCK2.
  • Clinical and Translational Updates
  • Please contact us via TechSupport@acrobiosystems.com if you have any question on this product.

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ETD of in-stock products: 2 business days

Price(USD) : $950.00

Price(USD) : $1400.00

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