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Publications
CAR T Cells, CTL Cells, DC Cells, NK Cells, T-Cells
G-Rex100M, G-Rex10M
Multi-antigen-targeting T cells in pediatric central nervous system tumors: a phase 1 trial
This phase 1 trial evaluates the safety and feasibility of multi-antigen-targeting T cells (TAA-T cells) in pediatric CNS tumors. The systemic therapy showed a favorable safety profile and preliminary efficacy. G-Rex10 and G-Rex100 devices are explicitly referenced for stimulating T cells during manufacturing.
Publications
B Cells, CAR T Cells, CD34 Cells, NK Cells, TCR T Cells, TIL Cells
A case study-based approach to integrating QbD principles in Cell-based Therapy CMC programs
This document presents A-CELL, a case study applying Quality by Design (QbD) principles to the manufacturing and CMC of cell therapies. It details regulatory frameworks, risk assessments, and control strategies, primarily using a hypothetical CAR-T product. G-Rex is not referenced in this document.
Publications
Other
Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments
This proposed FDA rule amends drug establishment registration to accommodate distributed manufacturing via a hub-and-spoke model. It also clarifies requirements for foreign establishments. G-Rex is not referenced in this document.
Publications
Treg Cells
G-Rex100M, G-Rex10M
Clinical development of tacrolimus-resistant regulatory T cells to enable simultaneous immunosuppression and immune regulation
This article details the clinical development of tacrolimus-resistant regulatory T cells (FKBP12KO-Tregs) using CRISPR-Cas9. This enables simultaneous immunosuppression and immune regulation in transplant recipients. For GMP-grade expansion, G-Rex 10 and G-Rex 100 bioreactors are explicitly used.
Publications
B Cells, T-Cells
G-Rex100M, G-Rex100M-CS
No compromise in cell expansion: Atract™ Kit T-cell activation reagent performance in closed G-Rex® systems
This white paper evaluates the Atract T-Cell Activation Kit comparing open and closed workflows. G-Rex 100M and G-Rex 100M-CS bioreactors are explicitly referenced for efficient T-cell expansion, demonstrating comparable high cell yields and low exhaustion markers across both setups.
Publications
CAR T Cells, NK Cells, T-Cells
G-Rex500M-CS
G-Rex bioreactors incubated in Heracell™ Vios™ CR CO₂ Incubators help prevent cross contamination and bacterial contamination in cell and gene modified cell therapy production
This article details how closed-system G-Rex bioreactors, specifically the G-Rex 500M-CS, paired with Heracell Vios incubators, prevent contamination in cell therapy production. It confirms G-Rex sterile fluid path integrity via microbial ingress and viral penetration testing.
Publications
B Cells, CAR T Cells, T-Cells
G-Rex6M – 2cm²
An Agile Phase I Platform Trial
This poster evaluates CAR T-cell manufacturing processes for an agile phase I trial. It compares 11-day manual methods, an automated Cocoon protocol, and a G-Rex platform. The study shortened the protocol to 7 days. G-Rex 2cm2 plates are explicitly referenced for efficient CAR T-cell expansion.
Publications
T-Cells
G-Rex10M-CS
Clinical-Grade Tumor-Reactive T Cells (TRT) from Antigen-Naïve Healthy Donors and Allogeneic Transplant Recipients
This study evaluates manufacturing clinical-grade tumor-reactive T cells using the CliniMACS Prodigy system. A closed-system G-Rex 10M-CS (GREX-CS) device is explicitly referenced for cell expansion to maximize throughput and support scalable, decentralized manufacturing.
