Publications
RESET: A TCR-coupled antigen receptor with superior targeting sensitivity and reversible drug-regulated anti-tumor activity
This study introduces RESET, a two-component receptor system engaging the endogenous TCR with drug-regulated control. RESET-T cells exhibited superior sensitivity and potency compared to CARs. G-Rex vessels were used for the culture and expansion of the engineered T cells during the study.
Publications
Protocol for isolation and expansion of natural killer cells from human peripheral blood scalable for clinical applications
This protocol describes the isolation and feeder-cell-based expansion of NK cells. To demonstrate clinical scalability, the method was tested on GMP-grade G-Rex 100M platforms, achieving clinically relevant numbers of highly pure and functional NK cells suitable for adoptive therapy.
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
Anti-CD137 agonist antibody– independent and clinically feasible preparation of tumor-infiltrating lymphocytes from soft tissue sarcoma and osteosarcoma
The authors developed a GMP-feasible protocol for expanding TILs from sarcoma without anti-CD137 agonist, using CD3/CD28 beads instead. The rapid expansion phase (REP) utilized G-Rex 10M, which achieved a 2- to 3-fold higher expansion compared to T-75 flasks, boosting clinical feasibility.
Publications
Enhancing CAR T-cell therapy manufacturing efficiency through semi-automated bioprocessing
This study demonstrates a semi-automated workflow for non-viral CAR T-cell production using digitally connected instruments. T cells were isolated, activated, and then cultured in G-Rex 100 and G-Rex 100M. The process yielded high-quality CAR T cells with reduced manual touchpoints and variability.
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
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
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
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
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
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.