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SMART Sensors for Cell Growth Monitoring in Closed System G-Rex: Supplemental Figures

This document provides supplemental data on the SMART sensor in G-Rex devices. It evaluates sensor responses to T cell-secreted metabolites, kerf width effects, and reader hardware temperature impact. G-Rex 100M is explicitly referenced as the cell culture vessel used for these tests.
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Publications

SMART sensors for cell growth monitoring in closed system G-Rex for scalable, cost-conscious cell and gene therapy manufacturing

This article describes integrating a SMART sensor into the G-Rex bioreactor for real-time, noninvasive monitoring of cell expansion. G-Rex devices, including the G-Rex 100M and 500M, are explicitly referenced as the core manufacturing platform for scaling CAR-T cell production.
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Publications

Kirigami-Enabled, Passive Resonant Sensors for Wireless Deformation Monitoring

This paper presents a kirigami-enabled passive resonant sensor to wirelessly monitor material deformation. The sensor responds to stretching via changes in capacitance and inductance. The study evaluates sensor gain and flow rate monitoring. G-Rex is not referenced in this document.
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Publications

LC Passive Wireless Sensors Toward a Wireless Sensing Platform: Status, Prospects, and Challenges

This paper reviews the status and challenges of LC passive wireless sensors. It covers sensing principles for pressure, temperature, and biochemical parameters. It discusses increasing interrogation distance and measuring multiple parameters. G-Rex is not referenced in this document.
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Publications

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.
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Publications

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.
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Publications

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.
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Publications

Clinical development of tacrolimus-resistant regulatory T cells to enable simultaneous immunosuppression and immune regulation

This study presents the clinical development and GMP manufacturing of gene-edited, tacrolimus-resistant regulatory T cells (FKBP12KO-Tregs) to prevent organ transplant rejection. Tregs are cultured in G-Rex 10 and 100 bioreactors for robust clinical-scale expansion with high viability.
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Publications

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.
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Publications

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.
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Publications

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.
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Publications

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.
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ScaleReady is a joint venture between Wilson Wolf Manufacturing and Bio-Techne.