Knowledge HQ

Miltenyi Biotec evaluates four automated CAR T cell manufacturing workflows. The study compares CliniMACS Prodigy and CliniMACS Plus systems for scalability. A G-Rex 500M bioreactor is paired with the CliniMACS Plus instrument to support automated cell enrichment and expanded culture capacity.

This guidance describes FDA CMC flexibilities for human cell and gene therapy products. It details approaches for clinical development, process validation, and specifications. G-Rex is not referenced in this document.

This guidance discusses methods for capturing postapproval safety and efficacy data for cell and gene therapy products. It explores the use of real-world evidence, electronic health records, and registries. G-Rex is not referenced in this document.

This guidance outlines innovative clinical trial designs for cell and gene therapy products in small populations. It details single-arm trials, disease progression modeling, and adaptive designs. G-Rex is not referenced in this document.

This document describes the Plausible Mechanism Framework for developing individualized therapies for specific genetic conditions. It covers regulatory, nonclinical, clinical, and CMC considerations. G-Rex is not referenced in this document.

This draft guidance provides recommendations for expedited development and review of regenerative medicine therapies for serious conditions. It outlines programs like RMAT, fast track, and breakthrough designations. G-Rex is not referenced in this document.

Provides guidance on the Pharmaceutical Development section for regulatory submissions [1]. Outlines Quality by Design (QbD) principles, design space, and control strategies to ensure product quality [2, 3]. G-Rex is not referenced in this document.

Develops a non-viral TcBuster engineering method for CD70 CAR NK cells. Armored cells secrete IL-15 and resist TGF-β suppression, enhancing cytotoxicity against osteosarcoma. G-Rex is referenced in the expansion workflow schematic on day 14 as the platform for CAR NK cell expansion.

Reviews genetic engineering strategies for Vδ1 γδ T cells, specifically ADI-270. Focuses on coexpressing a CD70 CAR and dnTGFβRII to target malignancies and resist the tumor microenvironment. G-Rex is not explicitly referenced.

The Cell Trajectory Modulation (CTM) assay provides rapid, label-free profiling of CAR T cell biophysical features like size and deformability. The study compares CAR T cells manufactured in G-Rex gas-permeable plates versus perfusion bioreactors, showing that biophysical signatures correlate with potency and phenotype.

This poster outlines a semi-automated GMP platform using artificial antigen presenting cells (aAPCs) to generate AML-specific CD8+ T cells. Following magnetic enrichment, the antigen-specific T cells were successfully expanded to clinically relevant numbers using G-REX expansion over a 14-day period.

This study investigates the efficacy of Delta One T (DOT) cells against colorectal cancer. It identifies NKG2D ligand upregulation and simultaneous TIGIT/PD1 blockade as strategies to enhance cytotoxicity. The expansion protocol for producing clinical-grade DOT cells utilized the G-REX platform with OpTmizer-CTS medium.