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Your Position: Home > Antibody > CD28 > GMP-MC2824

GMP Monoclonal Anti-Human CD28 Antibody DMF

Premium grade version CD8-M120b is now available for seamless transition.

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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. Batch-to-batch consistency

    6. Stringent quality control tests

  • Source
    HEK293 cells-expressed human GMP Monoclonal Anti-Human CD28 Antibody.
  • Isotype
    Mouse IgG1 | Mouse Kappa
  • Conjugate

    Unconjugated

  • Specificity
    This product is a specific antibody specifically reacts with CD28.
  • Endotoxin
    Less than 2 EU/mg by the LAL method / rFC 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.
  • Purity

    >95% as determined by SDS-PAGE.

    >95% as determined by SEC-HPLC.

  • Sterility
    The sterility testing was performed by membrane filtration method described in USP<71> and Ph. Eur. 2.6.1.
  • Mycoplasma
    Negative
  • Formulation

    Supplied as 0.2 μm filtered solution in PBS, polysorbate 80, pH7.4 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

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

    This product is stable after storage at:

    1. 2-8°C for 12 months under sterile condition;
    2. -70°C for 5 years.
SDS-PAGE
CD28 SDS-PAGE

GMP Monoclonal Anti-Human CD28 Antibody on SDS-PAGE under reducing (R) condition. The gel was stained with Coomassie Blue. The purity of the protein is greater than 95%.

SEC-HPLC
CD28 SEC-HPLC

The purity of GMP Monoclonal Anti-Human CD28 Antibody(Cat. No. GMP-MC2824) was greater than 95% as determined by SEC-HPLC.

Bioactivity-CELL BASE
 CD28 CELL

GMP Monoclonal Anti-Human CD28 Antibody (Cat. No. GMP-MC2824) stimulates secretion of IL-2 by PBMC stimulated with 4ng/mL GMP Monoclonal Anti-Human CD3 Antibody (OKT3). The typical EC50 for this effect is 1.382 ng/mL (QC tested).

 CD28 CELL

The activity of GMP Monoclonal Anti-Human CD28 Antibody (Cat. No. GMP-MC2824) was higher than other competing products.

Bioactivity-Stability
 CD28 STABILITY

The Cell based assay shows that GMP Monoclonal Anti-Human CD28 Antibody (Cat. No. GMP-MC2824) is stable at 37°C for 7 days.

 CD28 STABILITY

The Cell based assay shows that GMP Monoclonal Anti-Human CD28 Antibody (Cat. No. GMP-MC2824) is stable after freezing and thawing 3 times.

 CD28 STABILITY

The Cell based assay shows batch-to-batch consistency between Acro's GMP and PG CD28 Antibody.

  • 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
    T-cell-specific surface glycoprotein CD28 is also known as TP44, is a single-pass type I membrane protein which contains one Ig-like V-type (immunoglobulin-like) domain. is one of the molecules expressed on T cells that provide co-stimulatory signals, which are required for T cell activation. CD28 is the receptor for CD80 (B7.1) and CD86 (B7.2). When activated by Toll-like receptor ligands, the CD80 expression is upregulated in antigen presenting cells (APCs). The CD86 expression on antigen presenting cells is constitutive. CD28 is the only B7 receptor constitutively expressed on naive T cells.
  • Clinical and Translational Updates

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