【免费试用】GMP Activ

优势特色（Features）

1. Designed in ISO 9001:2015 and ISO 13485:2016 certified facility
2. Manufactured and QC tested under a GMP compliance factory
3. FDA DMF filed
4. Animal-Free materials
5. Beta-lactam materials free
6. Batch-to-batch consistency
7. GMP grade antibodies as raw materials with strict virus removal steps and testing
8. GMP grade recombinant HSA as excipient
9. Stringent quality control tests

背景（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.

存储（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.

无菌（Sterility）

The sterility testing was performed by membrane filtration method described in CP<1101>, USP<71> and Eur. Ph. 2.6.1.

内毒素（Endotoxin）

Less than 0.5 EU per mL by the LAL method.

制剂（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).

典型数据-Typical Data Please refer to DS document for the assay protocol.

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.