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.
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
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
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
Extracellular viral microRNAs as biomarkers of virus infection in human cells
The study identifies viral exmiRs as markers for live virus infection in T cells. Purified T cells were activated and cultured in a G-Rex 24-well plate.