Knowledge HQ
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.
Publications
High-dimensional temporal mapping of CAR T cells reveals phenotypic and functional remodeling during manufacturing
This study profiles CAR T cells across manufacturing. Transductions and expansion were carried out in G-Rex 6M vessels to support high-density cell growth.
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.
Publications
Generation and GMP scale-up of human CAR-T cells using non-viral Sleeping Beauty transposons for B cell malignances
The study reports the optimized GMP-grade manufacturing of TranspoCART19 cells. Following electroporation, cells were expanded for 11 days in G-Rex 100M devices, achieving high expansion and functionality.
Publications
AI-assisted quantification of tumor-infiltrating lymphocytes in colorectal cancer liver metastasis
This study develops AI models to quantify TILs in colorectal cancer liver metastasis. In the Rapid Expansion Protocol (REP) stage, TILs were cultured in G-Rex 100 M.