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Publications
B Cells, CAR T Cells, NK Cells, NKT Cells
G-Rex500M
A streamlined, end-to-end solution for robust and efficient large-scale CAR T manufacturing
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.
Publications
Other
Chemistry, Manufacturing, and Controls Flexibilities for Developing Human Cellular and Gene Therapy Products for a Biologics License Application
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.
Publications
Other
Postapproval Methods to Capture Safety and Efficacy Data for Cell and Gene Therapy Products
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.
Publications
Other
Considerations for the use of the Plausible Mechanism Framework to Develop Individualized Therapies that Target Specific Genetic Conditions with Known Biological Cause
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.
Publications
Other
Innovative Designs for Clinical Trials of Cellular and Gene Therapy Products in Small Populations
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.
Publications
CD34 Cells
Expedited Programs for Regenerative Medicine Therapies for Serious Conditions
This draft guidance provides recommendations for expedited development and review of regenerative medicine therapies for serious conditions.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.
Publications
Other
PHARMACEUTICAL DEVELOPMENT Q8(R2)
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.
Publications
B Cells, CAR T Cells, CTL Cells, DC Cells, NK Cells, γδ T
Non-viral TcBuster transposon engineering of CD70-CAR natural killer cells for the treatment of osteosarcoma
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.
