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Publications
Publications

CRISPR-Mediated Base Conversion Allows Discriminatory Depletion of Endogenous T Cell Receptors for Enhanced Synthetic Immunity

This study utilizes CRISPR base editing to disrupt endogenous TCRs while expressing a hepatitis B-specific recombinant TCR. Cells expanded in G-Rex showed high purity and enhanced functional avidity. This approach enables the production of potent, off-the-shelf TCR-T cells for treating HCC.
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Publications

Anti-CD30 CAR-T Cell Therapy in Relapsed and Refractory Hodgkin Lymphoma

This phase I/II study evaluates autologous CD30 CAR-T cells in relapsed/refractory Hodgkin lymphoma. Fludarabine-based lymphodepletion led to high response rates and durability. The therapy was safe with no neurotoxicity. The study highlights the potential of CD30 CAR-Ts for heavily pretreated patients.
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Publications

Virus-specific T-cell therapy to treat BK polyomavirus infection in bone marrow and solid organ transplant recipients

This phase 2 trial evaluates virus-specific T cells (VSTs) for treating BK polyomavirus in transplant recipients. Manufactured in G-Rex devices, donor-derived and third-party VSTs demonstrated high response rates for viremia and hemorrhagic cystitis with minimal toxicity, offering a safe therapy for BKPyV.
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Publications

A serum-free protocol for the ex vivo expansion of Cytokine-Induced Killer cells using gas-permeable static culture

This study presents a serum-free protocol for expanding Cytokine-Induced Killer (CIK) cells using G-Rex devices. The method reduced manipulation while yielding high cell numbers with a naive-like phenotype. G-Rex cultures supported efficient expansion and cytotoxic activity, suitable for clinical manufacturing.
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Publications

Autologous non-human primate model for safety assessment of piggyBac transposon-mediated chimeric antigen receptor T cells on granulocyte–macrophage colony-stimulating factor receptor

This study assesses the safety of piggyBac transposon-mediated hGMR-CAR T cells in a non-human primate model. Using G-Rex for expansion, researchers generated autologous CAR T cells that showed potent killing in vitro and no overt toxicity in vivo, supporting the safety of this approach for clinical trials.
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Publications

Methods and Process Optimization for Large-Scale CAR T Expansion Using the G-Rex Cell Culture Platform

This book chapter details the use of G-Rex technology for large-scale cell expansion. It covers protocols for G-Rex plates and closed systems, optimization of seeding and feeding, and harvesting. It highlights the linear scalability of the platform for CAR-T and NK cell production.
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Publications

AIM Platform: A Novel Nano Artificial Antigen-Presenting Cell-Based Clinical System Designed to Consistently Produce Multi-Antigen-Specific T-Cell Products with Potent and Durable Anti-Tumor Properties

This review describes the AIM platform, which uses nanoparticle-based artificial APCs to generate antigen-specific T cells. The enrichment and expansion (E+E) process, utilizing G-Rex culture systems, produces consistent, high-quality memory CD8+ T cells for clinical adoptive cell therapy applications.
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Publications

A soluble activator that favors the ex vivo expansion of CD8+CD27+ T cells

This study introduces T-CEP, a soluble activator for T cell expansion. G-Rex 24-well plates were used for the 12-day expansion period. T-CEP stimulation favored the growth of CD8+CD27+ T cells, a phenotype associated with better persistence and clinical outcomes.
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Publications

Identification of new cytokine combinations for antigen-specific T-cell therapy products via a high-throughput multi-parameter assay

The authors used a high-throughput assay to optimize cytokine conditions for VST expansion. Results showed IL-15/IL-6 was effective. These findings were validated by scaling up cultures in G-Rex 10 devices, which produced functional T cells equivalent to standard protocols.
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Publications

Preclinical Development and Clinical-Scale Manufacturing of HIV Gag-Specific, Lentivirus Modified CD4 T Cells for HIV Functional Cure

Describes a manufacturing process for HIV Gag-specific CD4 T cells modified with AGT103 lentivirus. The process was improved by combining CliniMACS Prodigy with static culture in G-Rex 500M-CS vessels, significantly increasing cell expansion and yield compared to the automated system alone.
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Publications

A multivariate, quantitative assay that disentangles key kinetic parameters of primary human T cell function in vitro

The authors developed the QuIK assay to measure proliferation and killing kinetics of engineered T cells. Primary human T cells were transduced and expanded in 24-well G-Rex plates. The assay provides detailed insights into the functional biology of CAR-T and TCR-T cells over time.
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Publications

Preclinical Validation and Manufacture of IL-8 Receptor-Modified CD70 CAR T Cells for Clinical Trial

Abstract describing the preclinical validation of IL-8 receptor-modified CD70 CAR T cells. The G-Rex system was used for ex vivo expansion, achieving approximately 1200-fold expansion in 2 weeks. The optimized process allows for clinical scale production using small blood volumes.
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