Knowledge HQ
Publications
Virus-specific T-cell therapy to treat BK polyomavirus infection in bone marrow and solid organ transplant recipients
This phase 2 trial evaluates virus-specific T cells (VSTs) for treating BK polyomavirus in transplant recipients. Manufactured in G-Rex devices, donor-derived and third-party VSTs demonstrated high response rates for viremia and hemorrhagic cystitis with minimal toxicity, offering a safe therapy for BKPyV.
Publications
Autologous non-human primate model for safety assessment of piggyBac transposon-mediated chimeric antigen receptor T cells on granulocyte–macrophage colony-stimulating factor receptor
This study assesses the safety of piggyBac transposon-mediated hGMR-CAR T cells in a non-human primate model. Using G-Rex for expansion, researchers generated autologous CAR T cells that showed potent killing in vitro and no overt toxicity in vivo, supporting the safety of this approach for clinical trials.
Publications
A soluble activator that favors the ex vivo expansion of CD8+CD27+ T cells
This study introduces T-CEP, a soluble activator for T cell expansion. G-Rex 24-well plates were used for the 12-day expansion period. T-CEP stimulation favored the growth of CD8+CD27+ T cells, a phenotype associated with better persistence and clinical outcomes.
Publications
AIM Platform: A Novel Nano Artificial Antigen-Presenting Cell-Based Clinical System Designed to Consistently Produce Multi-Antigen-Specific T-Cell Products with Potent and Durable Anti-Tumor Properties
This review describes the AIM platform, which uses nanoparticle-based artificial APCs to generate antigen-specific T cells. The enrichment and expansion (E+E) process, utilizing G-Rex culture systems, produces consistent, high-quality memory CD8+ T cells for clinical adoptive cell therapy applications.
Publications
Methods and Process Optimization for Large-Scale CAR T Expansion Using the G-Rex Cell Culture Platform
This book chapter details the use of G-Rex technology for large-scale cell expansion. It covers protocols for G-Rex plates and closed systems, optimization of seeding and feeding, and harvesting. It highlights the linear scalability of the platform for CAR-T and NK cell production.
Publications
Preclinical Development and Clinical-Scale Manufacturing of HIV Gag-Specific, Lentivirus Modified CD4 T Cells for HIV Functional Cure
Describes a manufacturing process for HIV Gag-specific CD4 T cells modified with AGT103 lentivirus. The process was improved by combining CliniMACS Prodigy with static culture in G-Rex 500M-CS vessels, significantly increasing cell expansion and yield compared to the automated system alone.
Publications
Identification of new cytokine combinations for antigen-specific T-cell therapy products via a high-throughput multi-parameter assay
The authors used a high-throughput assay to optimize cytokine conditions for VST expansion. Results showed IL-15/IL-6 was effective. These findings were validated by scaling up cultures in G-Rex 10 devices, which produced functional T cells equivalent to standard protocols.
Publications
Challenges and advantages of cell therapy manufacturing under Good Manufacturing Practices within the hospital setting
This review discusses establishing academic GMP facilities for cell therapy. It highlights the use of closed systems like G-Rex (referenced via Harari et al.) to improve efficiency and compliance. The article emphasizes the benefits of hospital-based manufacturing for personalized therapies like TILs.
Publications
Preclinical Validation and Manufacture of IL-8 Receptor-Modified CD70 CAR T Cells for Clinical Trial
Abstract describing the preclinical validation of IL-8 receptor-modified CD70 CAR T cells. The G-Rex system was used for ex vivo expansion, achieving approximately 1200-fold expansion in 2 weeks. The optimized process allows for clinical scale production using small blood volumes.
Publications
A multivariate, quantitative assay that disentangles key kinetic parameters of primary human T cell function in vitro
The authors developed the QuIK assay to measure proliferation and killing kinetics of engineered T cells. Primary human T cells were transduced and expanded in 24-well G-Rex plates. The assay provides detailed insights into the functional biology of CAR-T and TCR-T cells over time.
Publications
Photodepletion with 2-Se-Cl prevents lethal graft-versus-host disease while preserving antitumor immunity
This research demonstrates that photodepletion with 2-Se-Cl selectively removes alloreactive T cells to prevent GVHD without compromising antitumor immunity. G-Rex devices were utilized for the initial co-culture and priming of splenocytes before the photodepletion step.
Publications
Characterization of a Cytomegalovirus-Specific T Lymphocyte Product Obtained Through a Rapid and Scalable Production Process for Use in Adoptive Immunotherapy
This study characterizes CMV-specific T lymphocytes (VSTs) expanded rapidly for adoptive immunotherapy. Using G-Rex technology with IL-2, IL-7, and IL-15, researchers achieved a scalable process yielding functional, cytotoxic T cells. The method ensures high specificity and safety for treating viral infections.