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Publications
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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Publications

Challenges and advantages of cell therapy manufacturing under Good Manufacturing Practices within the hospital setting

This review discusses establishing academic GMP facilities for cell therapy. It highlights the use of closed systems like G-Rex (referenced via Harari et al.) to improve efficiency and compliance. The article emphasizes the benefits of hospital-based manufacturing for personalized therapies like TILs.
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Publications

Development of an optimized closed and semi-automatic protocol for Good Manufacturing Practice manufacturing of tumor-infiltrating lymphocytes in a hospital environment

The authors developed a GMP-compliant TIL expansion protocol using G-Rex and the Xuri bioreactor. Pre-REP expansion in G-Rex resulted in higher cell numbers compared to 24-well plates. The closed-system process reduced operator time and produced functional TILs suitable for clinical trials.
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Publications

Characterization of a Cytomegalovirus-Specific T Lymphocyte Product Obtained Through a Rapid and Scalable Production Process for Use in Adoptive Immunotherapy

This study characterizes CMV-specific T lymphocytes (VSTs) expanded rapidly for adoptive immunotherapy. Using G-Rex technology with IL-2, IL-7, and IL-15, researchers achieved a scalable process yielding functional, cytotoxic T cells. The method ensures high specificity and safety for treating viral infections.
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Publications

Photodepletion with 2-Se-Cl prevents lethal graft-versus-host disease while preserving antitumor immunity

This research demonstrates that photodepletion with 2-Se-Cl selectively removes alloreactive T cells to prevent GVHD without compromising antitumor immunity. G-Rex devices were utilized for the initial co-culture and priming of splenocytes before the photodepletion step.
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