Knowledge HQ

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-Rex®10 and G-Rex®100 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.

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.

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.

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.

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.

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.

This guidance provides Q&A on implementing ICH Q8, Q9, and Q10 guidelines. It covers pharmaceutical development, quality risk management, design spaces, control strategies, and quality systems. G-Rex® is not referenced in this document.

This draft guidance outlines how to leverage prior knowledge to advance the development of human gene therapy products incorporating genome editing. It covers chemistry, manufacturing, controls, nonclinical, and clinical data. G-Rex® is not referenced in this document.