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Your Position: Home > Cell Grade Beads > CD3 & CD28 > GMP-MBS001

GMP ActiveMax® Human T cell Activation/Expansion CD3/CD28 Beads

PG version MBS-C001 is now available for seamless transition.
The Magnetic Stand (Cat.No. MB-01 & Cat.No. MB-02) can be used in conjunction with Beads.

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ProductSizeAmount
GMP ActiveMax® Human T cell Activation/Expansion CD3/CD28 Beads10 mg1 × 10⁸ beads
100 mg (10 mg × 10)1 × 10⁹ beads
500 mg (10 mg × 50)5 × 10⁹ beads
  • Features
    1. Designed in ISO 9001:2015 and ISO 13485:2016 certified facility

    2. Manufactured and QC tested under a GMP compliance factory

    3. Animal-Free materials

    4. Batch-to-batch consistency

    5. GMP grade antibodies as raw materials with strict virus removal steps and testing
    6. GMP grade recombinant HSA as excipient
    7. Stringent quality control tests

  • Background
    GMP ActiveMax® Human T cell Activation/Expansion CD3/CD28 Beads are uniform 5.5 μm of magnetic beads coated with an optimized mixture of GMP grade mouse monoclonal antibodies against the CD3 and CD28, mimicking in vivo stimulation by APCs. GMP ActiveMax® Human T cell Activation/Expansion CD3/CD28 Beads are Manufactured under a GMP compliance factory with animal free raw materials, and tested under GMP guidelines. GMP ActiveMax® Human T cell Activation/Expansion CD3/CD28 Beads are intended for the in vitro isolation, stimulation and expansion of purified T cell populations of, for example, CD3+T cells, CD4+ T cells, CD8+ T cells or human PBMC for cell based clinical and preclinical research.
  • Storage
    The product MUST be stored at 2-8°C upon receipt; This product is stable after storage at 2-8°C for 5 years under sterile conditions.
  • Sterility
    The sterility testing was performed by membrane filtration method described in USP<71>.
  • Endotoxin
    Less than 0.5 EU per mL by the LAL method.
  • Formulation

    GMP ActiveMax Human T cell Activation/Expansion CD3/CD28 Beads is supplied with 5x10⁷ beads/mL in PBS, pH 7.4, with 0.1% recombinant human serum albumin (recombinant HSA).

Typical Data Please refer to Ds document for the assay protocol.
 CD3 & CD28 TYPICAL DATA

The human T cells were stimulated with GMP ActiveMax® Human T cell Activation/Expansion CD3/CD28 Beads (Cat. No. GMP-MBS001) for 24hrs, and the activation was assessed by measuring expression of both activation markers CD25 and CD69 expression on the T cells surface by stanning with PE labeled anti-human CD25 antibody and FITC labeled anti-human CD69 antibody respectively (QC tested).

 CD3 & CD28 TYPICAL DATA

The human T cells were labeled with carboxy fluorescein succinimidyl ester (CFSE) and stimulated with GMP ActiveMax® Human T cell Activation/Expansion CD3/CD28 Beads (Cat. No. GMP-MBS001), and then the proliferation of the T cells was assessed with CFSE dilution assay by flow cytometry on day 5 after stimulation (QC tested).

 CD3 & CD28 TYPICAL DATA

Activation of the purified human T Cells. The purified human T cells were activated using Human T cell Activation/Expansion CD3/CD28 Beads, (ACRO, Cat. No. GMP-MBS001) and Competitor-Beads respectively for 24 hours with CTS Optimizer Medium. Cells were fluorescently stained using PE labeled anti-human CD25 antibody and labeled FITC anti-human CD69 antibody and analyzed by flow cytometry.

 CD3 & CD28 TYPICAL DATA

Expansion of the human CD3+T cells. Human T cells using ACROBiosystems CD3/CD28 Beads (ACRO, Cat. No. GMP-MBS001) were expanded under two different medium, respectively. Expansion was performed for two weeks, showing that ACROBiosystems’ beads showing better proliferative abilities and comparable competitive ideas compared with competitor product.

 CD3 & CD28 TYPICAL DATA

PD-1 expression of the activated human T Cells. The purified human T cells were stimulated using Human T cell Activation/Expansion CD3/CD28 Beads at a ratio of 1:1 beads-to-cells. Cells were expanded in T cell culture medium supplemented with 4ng/mL of rhIL-2 Protein (Acrobiosystems, Cat. No. IL2-H4113). Activated T cells were expanded for up to 8 days with low PD-1 expression.

Stability
 CD3 & CD28 STABILITY

The Cell based assay shows that GMP ActiveMax® Human T cell Expansion CD3/CD28 Beads(GMP-MBS001) is stable at 37℃ for 35 days.

 CD3 & CD28 STABILITY

Activation of the purified human T Cells. The purified human T cells were activated using Human T cell Activation/Expansion CD3/CD28 Beads, (ACRO, Cat. No. GMP-MBS001/MBS-C001) respectively for 24 hours with CTS Optimizer Medium. Cells were fluorescently stained using PE labeled anti-human CD25 antibody and labeled FITC anti-human CD69 antibody and analyzed by flow cytometry.

  • 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 in ISO 9001:2015 and ISO 13485:2016 certified facility, Manufactured and QC tested under a GMP compliance factory.

    2. Animal-Free materials

    3. Materials purchased from the approved suppliers by QA

    4. Qualified personnel

    5. Quality-related documents review and approve by QA

    6. Fully batch production and control records

    7. Equipment maintenance and calibration

    8. Validation of analytical procedures

    9. Stability studies conducted

    10. 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

  • Clinical and Translational Updates

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