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A Cryopreserved Tumor Infiltrating Lymphocyte (TIL) Product for LN-144, Generated with an Abbreviated Method Suitable for High Throughput Commercial Manufacturing Exhibits Favorable Quality Attributes For Adoptive Cell Transfer

Describes Iovance's Gen 2 manufacturing process for LN-144 (TILs), an abbreviated 22-day closed process yielding cryopreserved product. The Gen 2 process uses a single closed bioreactor to improve scalability and throughput compared to the Gen 1 method.
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Publications

Surrogate in vitro activation of innate immunity synergizes with interleukin-7 to unleash rapid antigen-driven outgrowth of CD4+ and CD8+ human peripheral blood T-cells naturally recognizing MUC1, HER2/neu and other tumor-associated antigens

Describes a culture method using GM-CSF, TLR agonists, and IL-7 to expand antigen-specific T-cells from PBMC. The study confirmed the culture method could be scaled up using G-Rex 100M vessels, showing effectiveness comparable to 24-well plates for patient treatment.
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Publications

Mesothelin as a novel biomarker and immunotherapeutic target in human glioblastoma

Investigates mesothelin as an immunotherapeutic target in glioblastoma. Mesothelin-specific T-cell responses were detected in TILs. G-Rex were utilized for the further expansion of TILs isolated from glioma tumor tissue to achieve necessary cell numbers.
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Publications

Clinical-Scale Rapid Autologous BK Virus-Specific T Cell Line Generation From Kidney Transplant Recipients With Active Viremia for Adoptive Immunotherapy

Describes a clinical-scale protocol to generate autologous BK virus-specific T cell lines from kidney transplant recipients. G-Rex10 vessels were used for all T cell cultures, allowing for rapid expansion and generation of antigen-specific T cell lines suitable for adoptive immunotherapy.
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Publications

Toward a Rapid Production of Multivirus-Specific T Cells Targeting BKV, Adenovirus, CMV, and EBV from Umbilical Cord Blood

Developed a rapid method to produce multivirus-specific T cells from cord blood using overlapping PepMixes. G-Rex culture devices maintained or improved antigen recognition and overcame limitations in expanding sufficient cells for clinical application, allowing large-scale production.
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Publications

Single-cell profiling of dynamic cytokine secretion and the phenotype of immune cells

A single-cell methodology integrating cellular phenotyping and dynamic cytokine secretion was developed using nanowell arrays. G-Rex 100M were used for the rapid expansion protocol (REP) of tumor-infiltrating lymphocytes (TILs) to achieve desired cell numbers for experiments.
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Publications

Large-scale isolation and cytotoxicity of extracellular vesicles derived from activated human natural killer cells

Describes a method for large-scale isolation of extracellular vesicles (EVs) from activated NK cells. The G-Rex cell culture device allowed for the expansion of 1-3 billion aNK cells per 100 cm2, increasing EV production while reducing cost and complexity. Isolated EVs showed cytotoxicity against cancer cells.
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Publications

A single exercise bout enhances the manufacture of viral-specific T-cells from healthy donors: implications for allogeneic adoptive transfer immunotherapy

This study showed that collecting PBMCs after exercise increases the yield of VSTs. The VSTs were expanded in G-Rex10 for 8 days, demonstrating that exercise is a simple adjuvant for improving VST manufacture.
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Publications

Anti-proliferative effects of T cells expressing a ligand-based chimeric antigen receptor against CD116 on CD34+ cells of juvenile myelomonocytic leukemia

The authors developed GM-CSF Receptor (CD116) CAR T cells using the piggyBac transposon system. The transgenic CAR T cells were expanded in G-Rex 10 devices to generate effector cells for testing against JMML cells.
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Publications

Safety of Intra-Arterial Injection With Tumor-Activated T Cells to the Rabbit Brain Evaluated by MRI and SPECT/CT

This study evaluated the safety of intra-arterial TIL delivery in rabbits. The human TILs used for infusion were expanded from glioblastoma tumors using G-Rex to obtain sufficient cell numbers for the experiment.
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Publications

Large-Scale Culture and Genetic Modification of Human Natural Killer Cells for Cellular Therapy

Describes a GMP-compliant method for expanding NK cells using K562 feeder cells in G-Rex 10 and G-Rex 100. The method yields large numbers of functional NK cells in 10 days without feeding, and supports efficient retroviral transduction.
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Publications

Plasticity and Aggregation of Juvenile Porcine Islets in Modified Culture: Preliminary Observations

The study reports that culturing juvenile porcine islets in Wilson Wolf gas-permeable (G-Rex) allows them to aggregate into functional 'pancreatites'. These flasks were also used for shipping the islets, maintaining viability and function.
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