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Publications
Treg Cells
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.
Publications
Treg Cells
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.
Publications
CAR T Cells
Efficient nonviral integration of large transgenes into human T lymphocytes using Cas9-CLIPT
This study introduces Cas9-CLIPT, a method to efficiently integrate large transgenes (2-6 kb) into human T cells without restriction enzymes. It produces highly potent GD2 TRAC-CAR T cells with an enriched stem cell memory phenotype. G-Rex 6M well plates are referenced for cell cultivation post-electroporation.
Publications
CAR T Cells
Metabolic priming of GD2 TRAC-CAR T cells during biomanufacturing promotes memory phenotypes while enhancing persistence
This study describes ‘metabolic priming’ of GD2 TRAC-CAR T cells during manufacturing by activating them in glucose/glutamine-low medium and expanding in glucose/glutamine-high medium. This process enhances stem-like memory phenotypes and in vivo persistence. G-Rex6M plates are referenced for ex vivo cell expansion.
Publications
NK Cells, Other
G-Rex bioreactors incubated in Vios™ iDx CR CO2 Incubators help prevent cross contamination and bacterial contamination in cell and gene modified cell therapy production
This study demonstrates that closed-system G-Rex bioreactors combined with Thermo Scientific Vios iDx CR CO2 incubators significantly reduce contamination risks. G-Rex bioreactors eliminate manual handling, feature a validated sterile fluid path, and expand cells safely in low-grade cleanrooms.
Publications
CAR T Cells
Class I HDAC inhibition enhances the stem-like memory properties of CRISPR-engineered CAR T cells in neuroblastoma
This study shows that treating CRISPR-engineered GD2 TRAC-CAR T cells with the class I HDAC inhibitor chidamide enhances their stem cell memory phenotype (CD62L+/CCR7+/IL-7Rα+) and in vivo persistence without increasing exhaustion. Technical support on the G-Rex system from ScaleReady is acknowledged.
Publications
B Cells, CAR T Cells, NK Cells, T-Cells
Development of a 3-day manufacturing method to generate CD19-CD20-CD22 trispecific CAR T-cells from whole blood
This study outlines a rapid 3-day manufacturing method to generate CD19-CD20-CD22 trispecific CAR T-cells from whole blood. The process maintains high cell viability, transduction efficiency, and therapeutic potency. A G-Rex 10M vessel is explicitly used for the brief T-cell culture and expansion phase.
Publications
B Cells, CAR T Cells, T-Cells, TCR T Cells
G-Rex100M-CS, G-Rex6M – 10cm²
Integrated T-Cell Enrichment, Static Transduction, and Expansion in Gas-Permeable Bioreactors for Adoptive Cell Therapy
This study details an integrated, closed CAR T-cell manufacturing workflow. The process utilizes a G-Rex 100M-CS bioreactor for direct in-vessel CD4+/CD8+ magnetic enrichment using a prototype SepaRex base, static retroviral transduction, and T-cell expansion, eliminating separate selection or spinoculation devices.