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Publications

Allogeneic Polyclonal CD38KO/CD38-CAR γδT Cells For The Treatment Of T Cell Malignancies

This study develops CD38KO/CD38-CAR γδT cells to treat T-cell malignancies, avoiding fratricide. A hybrid expansion protocol using G-Rex plates allowed robust expansion of polyclonal γδT cells. The edited cells showed potent anti-tumor activity in vitro and in vivo against T-ALL.
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Publications

Targeting of acute myeloid leukemia by five-gene engineered T cells expressing transgenic T-cell receptor specific to WT1, chimeric antigenic receptor specific to GM-CSF receptor, bispecific T-cell engager specific to CD33 and tEGFR suicide gene system

This study describes T cells engineered with five genes (WT1-TCR, NFAT-GMCAR, CD33 BiTE, tEGFR) to target AML. G-Rex plates were used for co-culture assays with primary AML cells and bone marrow to evaluate cytotoxicity and safety. The strategy enhances anti-tumor potency and provides a safety switch.
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Publications

Iterative Process Development of an HDR Gene Edited HSPC Drug Product to Treat Sickle Cell Disease

This presentation details the process development (V2.0) for nula-cel, a gene-edited HSPC product for Sickle Cell Disease. G-Rex were implemented for cell culture, improving cell health and scalability compared to the V1.0 process. The optimized process showed improved engraftment and editing efficiency.
Publications

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

This paper outlines a process for producing SRC-3 knockout human Tregs using CRISPR-Cas9. G-Rex devices were used to scale up production, achieving a 25-40 fold expansion in 14 days. The protocol is compatible with GMP standards for clinical-scale manufacturing of engineered Tregs.
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Publications

CD147-CAR-NK cell therapy shows minimal toxicities in human CD147 transgenic mouse model with solid tumors

The study investigates the toxicity of CD147-CAR-NK therapy in a human CD147 transgenic mouse model. NK cells were expanded and transduced in G-Rex plates. Results indicate minimal on-target/off-tumor toxicities and less neuroinflammation compared to CAR-T therapy, supporting clinical potential.
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Publications

Donor insertion into CX3CR1 allows epigenetic modulation of a constitutive promoter on hematopoietic stem cells and its activation upon myeloid differentiation

This paper describes a knock-in strategy (KI-Ep) inserting a constitutive expression cassette into the CX3CR1 locus of HSPCs to regulate transgene expression. G-Rex systems were used for the long-term culture of edited HSPCs. The method enables low expression in stem cells and activation upon myeloid differentiation.
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Publications

Optimized GMP-grade production of non-viral Sleeping Beauty-generated CARCIK cells for enhanced fitness and clinical scalability

This study optimizes non-viral Sleeping Beauty CAR-CIK cell production. Switching from T-flasks to G-Rex reduced handling time and produced less differentiated cells with enhanced metabolic fitness and in vivo efficacy. The method was validated in GMP conditions for clinical scalability.
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Publications

Proof of concept of a fully enclosed CAR-T process without use of a biosafety cabinet

This study evaluates a fully enclosed CAR-T manufacturing process eliminating biosafety cabinets. It uses CellSeal Connect vials for cryopreservation and G-Rex for cell activation and expansion. Results show comparable cell expansion, viability, and transduction to standard open processes.
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Publications

Preclinical data and design of a phase I clinical trial of neoantigen-reactive TILs for advanced epithelial or ICB-resistant solid cancers

This study presents the design of a phase I clinical trial for NEXTGEN-TIL, a product selected for neoantigen recognition in solid tumors. It details preclinical expansion from biopsies. G-Rex vessels were used for clinical-scale GMP validation of the rapid expansion protocol (REP) to obtain sufficient cell doses.
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Publications

Increased functional potency of multi-edited CAR-T cells manufactured by a non-viral transfection system

This study compares Solupore and electroporation for manufacturing multi-edited CAR-T cells. Solupore-transfected cells showed higher viability, TSCM retention, and in vivo efficacy. 24-well G-Rex were used to assess cell proliferation and cytokine production, supporting metabolic health analysis.
Publications

Scalable Manufacturing of T Cells Using cGMP-Compliant Ancillary Reagents

This poster evaluates cGMP T cell expansion protocols using ImmunoCult reagents across G-Rex (6M plate and 50M bottle), Xuri, and PBS-MINI bioreactors. G-Rex produced high cell densities and yields of functional T cells, including central memory subsets, suitable for clinical manufacturing.
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Publications

Improving lung cancer tumor-infiltrating lymphocyte (TIL) manufacturing

This study describes the MC3 protocol for lung TIL manufacturing, which simplifies the process by using G-Rex for both preREP and REP phases and replacing feeder cells with CD3/CD28 nanobeads. The method reduced culture time and costs while producing TILs with superior cytotoxicity against tumor organoids.
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