Publications
Clinical manufacture of CRISPR/ Cas9-based cytokine-induced SH2 protein knock-out tumor-infiltrating lymphocytes for gastrointestinal cancers
This paper details the GMP manufacturing of CISH KO TILs for GI cancers. Tumor fragments were outgrown in 24-well G-Rex plates, and selected TILs were expanded in 100 cm² G-Rex vessels. An automated liquid handling system was developed to perform media exchanges directly in the G-Rex 24 plates.
Publications
Good manufacturing practice production of an off-the-shelf CD34+ progenitor-derived NK cell product with preserved anti-tumor functionality post-infusion in NOD/SCID/IL2Rgnull mice
This study presents a GMP-compliant process for manufacturing off-the-shelf NK cells from CD34+ HSPCs. The protocol was adapted to G-Rex 10M and 100M to facilitate scaling and reduce handling. The resulting NK cells showed high recovery, viability, and potent anti-tumor activity in vivo and in vitro.
Publications
Hypoimmune FK binding protein 12-knockout CD19 CAR T cells achieve deep tissue B-cell depletion and control Nalm6 tumors in immunosuppressed humanized mice
This paper describes the engineering of allogeneic CD19 CAR T cells with FKBP12 knockout to resist mTOR inhibitors like tacrolimus and rapamycin. The study utilized 24-well G-Rex plates for the recovery and expansion of nucleofected T cells. These cells demonstrated deep B-cell depletion in immunosuppressed mice.
Publications
Clinical grade expansion protocol for the manufacture of thymus-derived Treg cells for clinical application
This study establishes a GMP-compliant protocol for expanding thymus-derived regulatory T cells (Thy-Tregs). By optimizing CD8 depletion, CD25 enrichment, and cytokine stimulation, the authors achieved high purity. G-Rex (G-Rex 10 and 100) were successfully used to scale up production for clinical trials.
Publications
Cryopreserved G-CSF-Mobilized Apheresis Units in ATMP Manufacturing
This poster explores using cryopreserved G-CSF-mobilized apheresis units for manufacturing CIK and CAR-CIK cells. It compares manual versus automated washing and expansion methods. The use of G-Rex allowed for higher cell expansion in significantly less time (9-12 days) compared to standard.
Publications
Scaling up pluripotent stem cell-based therapies - considerations, current challenges and emerging technologies: perspectives from the ISCT Emerging Regenerative Medicine Working Group
This review addresses challenges in scaling iPSC-derived therapies, emphasizing automation, closed systems, and Quality-by-Design. It evaluates various technologies for expansion and differentiation. 1L and 5L G-Rex are referenced as technologies used for expansion during research and early process development.
Publications
Rapamycin-resistant polyclonal Th1/Tc1 cell therapy (RAPA-201) safely induces disease remissions in relapsed, refractory multiple myeloma
RAPA-201 T cells, reprogrammed via mTOR inhibition, showed safety and efficacy in RRMM patients. The manufacturing process involved incubating cells in G-REX culture vessels with cytokines and rapamycin.
Publications
T and B cell responses against Epstein–Barr virus in primary sclerosing cholangitis
This study analyzes adaptive immune responses in PSC. Cells were pulsed with peptides in a 24-well G-Rex device to generate EBV-specific T cell lines.
Publications
Generation of T cell responses against broad KRAS hotspot neoantigens for cell therapy or TCR discovery
The NEO-STIM process generates high-frequency T cell responses to KRAS neoantigens. The protocol utilizes G-Rex 24 Well Plates, G-Rex 6 Well Plates, and G-Rex 100M/500M closed-system vessels for cell culture and expansion.
Publications
In Vitro Evaluation of Genetically Unmodified Ligand-Armed Allogeneic Natural Killer Cells to Treat EGFR-Positive Glioblastoma
The study evaluates Pin-EGFR-armed eNK cells. CD3-negative cells were seeded into G-Rex 6M devices for expansion and transferred to 100 M G-Rex on day 7.
Publications
DNA-dependent protein kinase inhibitors PI-103 and samotolisib augment CRISPR/Cas9 knock-in efficiency in human T cells
The authors demonstrate that DNA-PK inhibitors enhance CRISPR/Cas9 KI efficiency. Under GMP-optimized conditions, T cells were cultured in G-Rex-100M vessels and seeded in G-Rex 24 well plates after electroporation.
Publications
Efficient and rapid GMP-scalable production of CAR-T and CIK cells
The authors developed an efficient protocol for expanding CAR-T and CIK cells using G-Rex 24 and G-Rex 6M devices. The study highlights the scalability and high cell yield obtained using these gas-permeable culture systems.