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PHARMACEUTICAL DEVELOPMENT Q8(R2)
Provides guidance on the Pharmaceutical Development section for regulatory submissions [1]. Outlines Quality by Design (QbD) principles, design space, and control strategies to ensure product quality [2, 3]. G-Rex is not referenced in this document.
Publications
B Cells, CAR T Cells, CTL Cells, DC Cells, NK Cells
Non-viral TcBuster transposon engineering of CD70-CAR natural killer cells for the treatment of osteosarcoma
Develops a non-viral TcBuster engineering method for CD70 CAR NK cells. Armored cells secrete IL-15 and resist TGF-β suppression, enhancing cytotoxicity against osteosarcoma. G-Rex is referenced in the expansion workflow schematic on day 14 as the platform for CAR NK cell expansion.
Publications
CAR T Cells, CTL Cells, NK Cells, NKT Cells, T-Cells
Genetic engineering and allogeneic optimization of Vδ1 γδ CAR- T cells (ADI- 270) for cancer immunotherapy
Reviews genetic engineering strategies for Vδ1 γδ T cells, specifically ADI-270. Focuses on coexpressing a CD70 CAR and dnTGFβRII to target malignancies and resist the tumor microenvironment. G-Rex is not explicitly referenced.
Publications
CAR T Cells, CTL Cells, NK Cells, NKT Cells, T-Cells
Genetic engineering and allogeneic optimization of Vδ1 γδ CAR- T cells (ADI- 270) for cancer immunotherapy [Review]
Explores genetic engineering of Vδ1 γδ T cells (ADI-270) with a CD70-targeted CAR and dnTGFβRII. Aims to overcome immunosuppression and host-versus-graft rejection in cancer immunotherapy. G-Rex is not referenced in this document.
Publications
CTL Cells
Generation of Tumor-Specific CD8+ T cells
This poster outlines a semi-automated GMP platform using artificial antigen presenting cells (aAPCs) to generate AML-specific CD8+ T cells. Following magnetic enrichment, the antigen-specific T cells were successfully expanded to clinically relevant numbers using G-REX expansion over a 14-day period.
Publications
CAR T Cells
Cell trajectory modulation: rapid microfluidic biophysical profiling of CAR T cell functional phenotypes
The Cell Trajectory Modulation (CTM) assay provides rapid, label-free profiling of CAR T cell biophysical features like size and deformability. The study compares CAR T cells manufactured in G-Rex gas-permeable plates versus perfusion bioreactors, showing that biophysical signatures correlate with potency and phenotype.
Publications
NK Cells
Enhancement of anti-sarcoma immunity by NK cells engineered with mRNA for expression of a EphA2-targeted CAR
This study demonstrates that NK cells engineered with mRNA to express an EphA2-targeted CAR exhibit enhanced cytotoxicity against pediatric sarcomas. The protocol involved expanding human primary NK cells in G-Rex 24 multi-well cell culture plates using supplemented NK MACS media and activation beads or feeder cells.
Publications
T-Cells
Dual modulation of cytotoxic and checkpoint receptors tunes the efficacy of adoptive Delta One T cell therapy against colorectal cancer
This study investigates the efficacy of Delta One T (DOT) cells against colorectal cancer. It identifies NKG2D ligand upregulation and simultaneous TIGIT/PD1 blockade as strategies to enhance cytotoxicity. The expansion protocol for producing clinical-grade DOT cells utilized the G-REX platform with OpTmizer-CTS medium.