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Publications

CAR T cell engineering impacts antigen-independent activation and co-inhibition

Lentiviral and non-viral Sleeping Beauty manufacturing were compared for R110- and CD19-CAR T cells. Transposon products shifted to CD8+ subsets with activation and co-inhibition markers and inflammatory nucleotide-sensing signatures. Both arms were expanded in G-Rex® 24-well vessels.
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Publications

TSCM-predominant allogeneic anti-BCMA CAR-T therapy for relapsed/refractory multiple myeloma: preclinical characterization and interim results from a phase 1 trial

P-BCMA-ALLO1 is an allogeneic anti-BCMA CAR-T therapy with a TSCM-predominant phenotype. Preclinical lots and interim phase 1 data in relapsed/refractory myeloma showed 82% response with enhanced lymphodepletion. After electroporation, cells were pooled and cultured overnight in a G-Rex® vessel.
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Publications

Tumor-infiltrating lymphocyte expansion protocols for adoptive cell therapy in cancer

This review examines tumor-infiltrating lymphocyte (TIL) expansion protocols for adoptive cell therapy. It discusses modifications like cytokines (IL-7, IL-15, IL-21) and closed manufacturing systems. G-Rex® devices are referenced as a specialized system to optimize clinical-scale therapeutic T-cell expansion.
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Publications

Comparison of lentiviral promoters on the therapeutic efficacy of tri-specific CAR-T cells targeting CD19/CD20/CD22

This abstract compares EF1α and MND promoters in tri-specific CAR-T cells targeting CD19/CD20/CD22. MND vectors achieve higher expression, while EF1α shows faster tumor clearance in vivo. The G-Rex® 6M system was used for scale-up studies in preparation for manufacturing in G-Rex® 100M.
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Publications

Targeting triple-negative breast cancer using cord-blood CD34⁺ HSPC-derived mesothelin-specific CAR-NKT cells with potent antitumor activity

This study develops Allo15MCAR-NKT cells from gene-engineered cord-blood CD34+ HSPCs to target triple-negative breast cancer. The NKT cells home to lungs and bone marrow, reprogram the immunosuppressive tumor microenvironment, and safely suppress metastatic tumors. G-Rex® is not referenced in this document.
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Publications

Selective expansion of T-cell receptor engineered T cells with increased stem-like phenotypes using neoantigen stimulation

This study introduces NeoExpand, a platform to selectively expand TCR-engineered T cells against neoantigens while preserving stemness. G-Rex® culture systems (including 24-well and 6-well formats and G-Rex® 100 flasks) are referenced for executing cell activation and rapid expansion protocols.
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Publications

Feeder cell-free production of CAR-NK cells via activation of PKC and calcium signaling pathways

This article describes a novel feeder cell-free method to activate and expand human CAR-NK cells using PMA and ionomycin. Large-scale manufacturing in G-Rex® bioreactors, such as G-Rex® 6-well plates, successfully supports high cell viability, comparable transduction, and significantly enhanced potency.
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Publications

A Scalable Protocol for Ex Vivo Production of CAR-Engineered Human NK Cells

This protocol details ex vivo manufacturing of CAR-engineered human NK cells from peripheral blood. It optimizes immunomagnetic isolation, viral transduction, and cell expansion. G-Rex® system devices, specifically G-Rex® 6-well plates, are recommended to achieve robust NK cell expansion and high cell yields.
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Publications

Robust, scalable and xeno-free protocol for differentiating human induced pluripotent stem cells into functional macrophages

This study presents a robust, scalable, xeno-free protocol to differentiate human induced pluripotent stem cells into functional macrophages. Culturing myeloid progenitors in G-Rex® bioreactors, including proposed scaling to G-Rex® 10, 50, and 500 models, significantly optimizes cell yield and purity.
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Publications

Fratricide-resistant anti-CD7 CAR-T cells for relapsed/refractory Acute Myeloid Leukemia

This study evaluates fratricide-resistant anti-CD7 CAR T-cells in acute myeloid leukemia. The therapy exhibits potent anti-leukemic activity with minimized fratricide of engineered cells. G-Rex® is not referenced in this document.
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Publications

Clinical development of tacrolimus-resistant regulatory T cells to allow simultaneous immunosuppression and immune regulation

This study presents the clinical development and GMP manufacturing of gene-edited, tacrolimus-resistant regulatory T cells (FKBP12KO-Tregs) to prevent organ transplant rejection. Tregs are cultured in G-Rex® 10 and 100 bioreactors for robust clinical-scale expansion with high viability.
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Publications

CRISPR-Cas9 engineering of human T regulatory cells – Design and optimization of a production process

This study optimizes isolation, CRISPR-Cas9 knockout of SRC-3, and expansion of human regulatory T cells (Tregs) for adoptive cell therapy in solid tumors. Using G-Rex® bioreactors, they achieved a 25-to-40-fold expansion rate, maintaining high FOXP3 expression and viability.
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