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| Product | Size | Amount |
| GMP ActiveMax® Human T cell Activation/Expansion CD3/CD28 Beads | 10 mg | 1 × 10⁸ beads |
| 100 mg (10 mg × 10) | 1 × 10⁹ beads | |
| 400 mg (10 mg × 40) | 4 × 10⁹ beads |
Designed in ISO 9001:2015 and ISO 13485:2016 certified facility
Manufactured and QC tested under a GMP compliance factory
FDA DMF filed
Animal-Free materials
Beta-lactam materials free
Batch-to-batch consistency
GMP grade antibodies as raw materials with strict virus removal steps and testing
GMP grade recombinant HSA as excipient
Stringent quality control tests
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).
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).
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).
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.
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.
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. Activated T cells were expanded for up to 8 days with low PD-1 expression.
The Cell based assay shows that GMP ActiveMax® Human T cell Expansion CD3/CD28 Beads(GMP-MBS001) is stable at 37℃ for 35 days.
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.
Expansion of the human CD3+T cells. Human T cells using ACROBiosystems CD3/CD28 Beads (ACRO, Cat. No. GMP-MBS001/MBS-C001) were expanded under two different medium, respectively. Expansion was performed for two weeks, showing that ACROBiosystems’ GMP and PG beads showing similar proliferative abilities.
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. Activated T cells were expanded for up to 8 days with low PD-1 expression.
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：
Designed in ISO 9001:2015 and ISO 13485:2016 certified facility, Manufactured and QC tested under a GMP compliance factory.
Animal-Free materials
Materials purchased from the approved suppliers by QA
Qualified personnel
Quality-related documents review and approve by QA
Fully batch production and control records
Equipment maintenance and calibration
Validation of analytical procedures
Stability studies conducted
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:
SDS-PAGE
Protein content
Endotoxin level
Residual Host Cell DNA content
Residual Host Cell Protein content
Biological activity analysis
Microbial testing
Mycoplasma testing
In vitro virus assay
Batch-to-batch consistency
Price(USD) : $600.00
Price(USD) : $1800.00
Price(USD) : $5400.00
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