GMP ActiveMax® human T cell magnetic beads

GMP ActiveMax^® Human T Cell Activation/Expansion CD3/CD28 Beads are uniform 5.5 μm magnetic beads coated with an optimized mixture of GMP-grade mouse monoclonal antibodies targeting CD3 and CD28, mimicking in vivo APC stimulation.

Manufactured in a GMP-compliant facility using animal-free raw materials and tested under GMP guidelines, these beads are designed for in vitro isolation, stimulation, and expansion of purified T cell populations, including CD3+ T cells, CD4+ T cells, CD8+ T cells, or human PBMCs, for cell-based clinical and preclinical research.

Source: ACROBiosystems

Features

• Designed in an ISO 9001:2015 and ISO 13485:2016 certified facility
• Manufactured and QC tested in a GMP-compliant facility
• FDA DMF filed
• Animal-free materials
• Beta-lactam-free formulation
• Consistent batch-to-batch quality
• GMP-grade antibodies as raw materials, with strict virus removal steps and testing
• GMP-grade recombinant HSA as an excipient
• Stringent quality control testing

Storage

After being received, the product must be stored between 2 °C and 8 °C. It remains stable for five years when stored in a sterile environment.

Sterility

The membrane filtration method outlined in CP<1101>, USP<71>, and Eur. Ph. 2.6.1 was used to conduct the sterility test.

Endotoxin

Less than 0.5 EU per mL by the LAL method.

Formulation

GMP ActiveMax^® Human T Cell Activation/Expansion CD3/CD28 Beads are supplied at a concentration of 5 × 10⁷ beads/mL in PBS (pH 7.4), containing 0.1% recombinant human serum albumin (recombinant HSA).

ACRO quality management system

• ISO, GMP, and QMS
• Quality Benefits
• Procedure for Quality Control

Typical data

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

Image Credit: ACROBiosystems

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). T cell proliferation was then assessed on day 5 after stimulation using a CFSE dilution assay by flow cytometry (QC tested).

Image Credit: ACROBiosystems

The purified human T cells were activated for 24 hours with CTS Optimizer Medium, using Human T Cell Activation/Expansion CD3/CD28 Beads (ACRO, Cat. No. GMP-MBS001) and Competitor-Beads. After activation, the cells were stained with PE-conjugated anti-human CD25 antibody and FITC-conjugated anti-human CD69 antibody. Flow cytometry was used for analysis of the stained cells.

Image Credit: ACROBiosystems

Human CD3+ T cells were expanded using ACROBiosystems CD3/CD28 Beads (ACRO, Cat. No. GMP-MBS001) in two different media for a period of two weeks. The results indicated that ACROBiosystems’ beads demonstrated superior proliferative capabilities while maintaining similar competitive performance when compared to the competitor product.

Image Credit: ACROBiosystems

The purified human T cells were activated using Human T Cell Activation/Expansion CD3/CD28 Beads at a 1:1 beads-to-cells ratio. The cells were cultured in T cell medium supplemented with 4 ng/mL of rhIL-2 Protein. After activation, the T cells were expanded for up to 8 days, showing minimal PD-1 expression.

Image Credit: ACROBiosystems

Human CD4+ cells were activated using GMP ActiveMax Human T Cell Activation/Expansion CD3/CD28 Beads (Cat. No. GMP-MBS001) and cultured with GMP Human IL-2 Protein (Cat. No. GMP-L02H14), GMP Human TGF-Beta 1 Protein (Cat. No. GMP-TG1H25), Rapamycin, all-trans retinoic acid, sodium butyrate, and CelThrea^TM GMP T Cell Expansion Medium (Cat. No. GMP-CM3101) for two weeks.

The results demonstrated that the combination of CelThrea^TM GMP T Cell Expansion Medium, GMP ActiveMax Beads, GMP Human IL-2 Protein, and GMP Human TGF-Beta 1 Protein effectively supports the expansion of Treg cells while maintaining reasonable cell viability.

Image Credit: ACROBiosystems

Human CD4+ cells were activated using GMP ActiveMax Human T Cell Activation/Expansion CD3/CD28 Beads (Cat. No. GMP-MBS001) and cultured with GMP Human IL-2 Protein (Cat. No. GMP-L02H14), GMP Human TGF-Beta 1 Protein (Cat. No. GMP-TG1H25), Rapamycin, all-trans retinoic acid, sodium butyrate, and CelThrea^TM GMP T Cell Expansion Medium (Cat. No. GMP-CM3101) for two weeks.

The results indicated that CelThrea^TM GMP T Cell Expansion Medium, combined with GMP ActiveMax^® Beads, GMP Human IL-2 Protein, and GMP Human TGF-Beta 1 Protein, successfully increased the percentage of CD4+CD25+CD127lo/- cells. Furthermore, the proportion of CD4+CD25+CD127lo/- cells remained stable over the course of the culture period.

Image Credit: ACROBiosystems

Stability

GMP ActiveMax^® Human T cell Expansion CD3/CD28 Beads (GMP-MBS001) exhibit stability at 37 °C for 35 days, according to the cell-based assay.

Image Credit: ACROBiosystems

The purified human T cells were activated for 24 hours using Human T Cell Activation/Expansion CD3/CD28 Beads (ACRO, Cat. No. GMP-MBS001/MBS-C001) in CTS Optimizer Medium. After activation, the cells were stained with PE-conjugated anti-human CD25 antibody and FITC-conjugated anti-human CD69 antibody, and analyzed using flow cytometry.

Image Credit: ACROBiosystems

Human CD3+ T cells were expanded using ACROBiosystems CD3/CD28 Beads (ACRO, Cat. No. GMP-MBS001/MBS-C001) in two different media for a duration of two weeks. The results demonstrated that both ACROBiosystems' GMP and PG beads exhibited comparable proliferative abilities.

Image Credit: ACROBiosystems

The purified human T cells were stimulated using Human T Cell Activation/Expansion CD3/CD28 Beads at a 1:1 beads-to-cells ratio. The cells were cultured in T cell medium supplemented with 4 ng/mL of rhIL-2 Protein. After activation, the T cells were expanded for up to 8 days, exhibiting low levels of PD-1 expression.

Image Credit: ACROBiosystems