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Your Position: Home > 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
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
Product Features
CMC Production Process of Adoptive T Cell TherapiesEfficiently activate and expand T cells
CMC Production Process of Adoptive T Cell TherapiesAdheres to GMP grade quality system
CMC Production Process of Adoptive T Cell TherapiesAnimal-free materials for enhanced safety
CMC Production Process of Adoptive T Cell TherapiesRigorous viral removal steps and testing
CMC Production Process of Adoptive T Cell TherapiesHigh stability; high batch-to-batch consistency
Effective stimulation and Excellent proliferation
T cell Activation

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).

T cell Activation

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).

T cell Activation

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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T Cell Culture

Common Types of T Cells Cultured in vitro

CAR-T细胞

CAR-T

TCR-T细胞

TCR-T

TIL

Treg细胞

Treg

After activation, T cells also rely on various cytokines (IL-2, IL-7, IL-15, IL-21, and TNF- α, etc.) to further promote proliferation and activation.

GMP-grade products for T cell culture
Product Features
CMC Production Process of Adoptive T Cell TherapiesComprehensive quality release verification, with 16 quality control indicators
CMC Production Process of Adoptive T Cell TherapiesEnhanced safety (aseptic mycoplasma, exogenous virus, residual endotoxin testing)
CMC Production Process of Adoptive T Cell TherapiesPharmaceutical-grade production facility
CMC Production Process of Adoptive T Cell TherapiesSupport for online and offline audits
CMC Production Process of Adoptive T Cell TherapiesCompletion of FDA Drug Master File (DMF) registration
High expansion
T cell Culture

Figure 1. Cell growth curves of PBMCs cultured with IL-2. Varying concentrations of GMP IL-2 (Cat. No. GMP-L02H14) were added as a growth factor supplement to PBMCs revealing optimal cell expansion using a concentration of 500 IU/mL at Day 14.

T cell Culture

Figure 2. Cell viability curve of PBMCs cultured with IL-2. Increasing concentrations of GMP IL-2 (Cat. No. GMP-L02H14) were added as a growth factor supplement to PBMCs showing consistent and high cell viabilities up to Day 14.

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T Cell Engineering

In allogeneic CAR-T therapy, the introduction of CRISPR/Cas gene editing technology can be used to control the risk of recipient immune system rejection of injected cells, and to some extent, minimize the onset of GVHD (graft-versus-host disease).
GMP-grade products for T cell Engineering
Product Features
CMC Production Process of Adoptive T Cell TherapiesHigh purity, high enzyme activity, high cleavage efficiency
CMC Production Process of Adoptive T Cell TherapiesPossesses nuclear localization signals to enhance editing efficiency
CMC Production Process of Adoptive T Cell TherapiesAseptic, ultra-low endotoxin
CMC Production Process of Adoptive T Cell TherapiesProduced in GMP-compliant facilities and undergoes QC testing
Validation Data
T cell Engineering High biological activity verified by in vitro and in vivo enzyme activity, high TCR knockout activity.
T cell Engineering
T cell Engineering

Different amounts of Cas9 were incubated with the same amount of excess gRNA and plasmid for 60 minutes at 37°C. When using 400-200 ng Acro Cas9, the cutting efficiency is greater than 90%. In comparison, when using a 200 ng Competitor T, the cutting efficiency is only about 50%.

T cell Engineering
T cell Engineering

The TCR knockout efficiency with GMP GENPower™ NLS-Cas9 Nuclease in human primary T cells, GMP GENPower™ NLS-Cas9 Nuclease achieved over 95% knockout efficiency.

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Process Purification

Process Purification

The production of lentiviral packaging plasmids is a critical step in CAR-T cell preparation. During this process, nucleic acid residues can be generated including host residual nucleic acid, poses significant safety concerns due to potential infectious or tumorigenic risks.

Our enzyme modification technology platform, coupled with collaborative AI simulation and high-throughput screening, helped us independently develop several GMP-grade nucleases (conventional: GMP-NUES19, salt active: GMP-NUES13). Both are ideal choices for removing nucleic acid contamination in your biopharmaceutical process flow.

GMP-grade products for CMC process purification
Product Features
CMC Production Process of Adoptive T Cell TherapiesWide range of salt concentration adaptation, maintains high enzyme activity under medium to high salt conditions
CMC Production Process of Adoptive T Cell TherapiesHigh stability, retains enzyme activity at 37°C for 21 days without impairment
CMC Production Process of Adoptive T Cell TherapiesDownstream processes do not require dialysis or desalination, saving time
CMC Production Process of Adoptive T Cell TherapiesProduced under GMP conditions, meeting the requirements from research to large-scale production
Validation Data
T cell EngineeringHigh enzyme activity
T cell Engineering

GMP Salt Active GENIUS ™ Nuclease (Cat. No. GMP-NUES13) can maintain high enzyme activity under 0-500mM NaCl conditions; The enzyme activity of GMP-NUES13 under 0-500mM conditions is significantly better than that of competitors.

T cell EngineeringHigh nucleic acid removal effect
T cell Engineering

Using a cell homogenate containing 6.5E+06cell/mL HEK293, host cell DNA residue was detected by qPCR after being treated with 40U/mL salt active nuclease for 30 minutes. The results showed the DNA residues after treatment with GMP Salt Active GENIUS ™ (Cat. No. GMP-NUES13) is extremely low, and the nucleic acid clearance effect is better than that of competitors.

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Resources

What does GMP mean to us?

High biological activity
CMC Production Process of Adoptive T Cell Therapies

GMP Human IL-15 Protein (Cat. No. GMP-L15H13) stimulates proliferation of CTLL-2 cells. The specific activity of GMP Human IL-15 is > 8.00ⅹ10^6 IU/mg, which is calibrated against human IL-15 WHO International Standard (NIBSC code: 95/554) (QC tested).

CMC Production Process of Adoptive T Cell Therapies

The activity of GMP Human IL-7 Protein (Cat. No. GMP-L07H24) was higher than other competing products.

High stability
CMC Production Process of Adoptive T Cell Therapies

The Cell based assay shows that GMP Human IL-7 Protein (Cat. No. GMP-L07H24) is stable after freezing and thawing 3 times.

CMC Production Process of Adoptive T Cell Therapies

The Cell based assay shows that GMP Human IL-21 Protein (Cat. No. GMP-L21H25) is stable at 4°C for 6 months.

High batch to batch consistency
CMC Production Process of Adoptive T Cell Therapies

The cell activity of GMP Human IL-15 (Cat. No. GMP-L15H13) remains consistent across different batches and exhibits high batch to batch consistency.

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CMC Production Process of Adoptive T Cell Therapies
CMC Production Process of Adoptive T Cell Therapies
CMC Production Process of Adoptive T Cell Therapies
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