Knowledge HQ

This study details an integrated, closed CAR T-cell manufacturing workflow. The process utilizes a G-Rex 100M-CS bioreactor for direct in-vessel CD4+/CD8+ magnetic enrichment using a prototype SepaRex base, static retroviral transduction, and T-cell expansion, eliminating separate selection or spinoculation devices.

This document provides supplemental data for the SMART culture vessel study. It details chemical solvents, concentrations, liposome additions, and experimental controls like phosphate-buffered saline. G-Rex is not explicitly referenced in this supplemental document.

This article details a single-use metabolite absorbing resonant transducer (SMART) for continuous cell culture monitoring. Polyacrylate films absorb secreted metabolites, altering sensor permittivity. G-Rex10 static culture vessels are explicitly referenced for validating sensor sensitivity to live cells.

This paper proposes a low-cost, portable readout system to wirelessly interrogate LC resonant sensors. Using coherent demodulation and a direct digital synthesizer, the system successfully tracks temperature changes in water. G-Rex is not referenced in this document.

This review discusses contact-free, passive electromagnetic resonant sensors for biomedical applications. It highlights challenges like environmental noise and positional sensitivity, proposing differential sensors to increase specificity. G-Rex is not referenced in this document.

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.

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.

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.

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.

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.

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.

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.