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.
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.
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.
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.
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.
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.
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.
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.
Publications
Inhibition of MICA and MICB Shedding Elicits NK cell–mediated Immunity against Tumors Resistant to Cytotoxic T cells
The study demonstrates that blocking MICA/B shedding enables NK cells to target tumors with MHC-I or IFN-gamma pathway mutations. Human NK cells were expanded in vitro using G-Rex 6-well plates. This therapeutic strategy effectively reduced metastases in humanized mouse models.
Publications
Optimization and Scale-up of Treg Expansion from CD4+ Cells in G-Rex6M plates
This poster details the optimization of Treg expansion using Cloudz™ Treg CD3/CD28 microspheres. The method achieved high purity and cell numbers. Scalability was demonstrated using G-Rex6M plates, which utilize a gas-permeable membrane to support efficient cell growth in serum-free media.
Publications
Detection of response to tumor microenvironment–targeted cellular immunotherapy using nano-radiomics
This study explores nano-radiomics to assess response to MDSC-directed NK cell therapy in solid tumors. Human NK cells were activated and expanded in G-Rex devices for in vivo testing. Radiomic analysis of CT images successfully identified treatment responses that conventional tumor metrics failed to detect.
Publications
Generation of Antitumor T Cells For Adoptive Cell Therapy With Artificial Antigen Presenting Cells
This study develops renewable artificial antigen presenting cells (aAPCs) for T cell expansion and transduction. Using G-Rex , aAPCs supported efficient production of CAR T cells and TILs with less exhaustion and higher potency than bead-based methods, offering a cost-effective manufacturing alternative.