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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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

The authors developed 'enGager', a Cas9 fusion system that tethers cssDNA donors to enhance non-viral targeted integration. Used to engineer CD19/CD22 dual CAR-T cells. Post-electroporation, T cells were transferred to G-Rex 24-well plates for expansion, achieving high knock-in efficiency and cell viability.

This abstract presents SENTI-202, a logic-gated CAR-NK therapy for AML. The EMCN inhibitory CAR protects healthy HSCs from off-tumor toxicity. R&D scale CAR-NK cell manufacturing utilized 1L G-Rex for expansion, achieving high cell numbers and viability while maintaining logic gate function.