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CMC Production Process of Adoptive T Cell Therapies

T lymphocytes play a crucial role in the human immune system, and transferable T cell therapy utilizes the inherent functions of specific T cells to combat diseases. Common T cell-based therapies include CAR-T therapy, TIL therapy, etc., which as revolutionary techniques, have generated persistent and effective clinical responses in patients. Currently, scaling-up the CMC process for engineering T cells is one of the major challenges in this field, involving various complex procedures such as ex vivo activation, expansion, and engineering modification of T cells.

Our focus is on supporting research related to immune cell therapy. With a robust cell culture platform, antibody development platform, flow cytometry validation platform, and GMP quality management system, we offer a series of reagents for the CMC production process of T cells to help our customers accelerate their production processes.

CMC Production Process of Adoptive T Cell Therapies

T Cell Activation
T Cell Culture
T Cell Engineering
Process Purification

T Cell Activation

Typically, anti-CD3 antibody and anti-CD28 antibody or CD3/CD28 antibody-conjugated beads are used to mimic the first and second signaling processes in vivo to activate T cells, along with the addition of relevant cytokines.

GMP-grade products for T cell activation

CMC Production Process of Adoptive T Cell Therapies GMP Monoclonal Anti-Human CD3 Antibody (OKT3)

CMC Production Process of Adoptive T Cell Therapies GMP ActiveMax® Human T cell Activation/Expansion CD3/CD28 Beads

CMC Production Process of Adoptive T Cell Therapies GMP Human 4-1BB Ligand Protein

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Product Features

Efficiently activate and expand T cells

Adheres to GMP grade quality system

Animal-free materials for enhanced safety

Rigorous viral removal steps and testing

High stability; high batch-to-batch consistency

Effective stimulation and Excellent proliferation

Figure 1. 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).

Figure 2. 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).

Figure 3. Activation of the purified human T Cells. The purified human T cells were activated using Human T cell Activation/Expansion CD3/CD28 Beads, (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.

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