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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 application note highlights the CliniMACS Prodigy as an adaptable hub for automated cell processing. It details a CAR T cell manufacturing workflow using the CliniMACS Prodigy integrated with a G-Rex® 500M-CS bioreactor for the expansion phase. This hybrid approach enables automated harvest and high yields.

Kincell Bio partnered with Syenex to evaluate the RapidCell engineered vector for CD19-targeting CAR-T manufacturing. The vector eliminates activation reagents and isolation steps, reducing processing time by 40% and cost of goods by 55%. G-Rex® is not referenced in this document.

A 10-day clinical-scale TCR-T manufacturing protocol using IL-2, IL-7, IL-15, and TGF-β generates KRAS G12D-targeting cells enriched in early memory and tissue-resident phenotypes. G-Rex® 6M-2 bioreactors were used for small-scale and G-Rex® 100M flasks for clinical-scale expansion, yielding 3.3-6.15 x 10⁹ cells.

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 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 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 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.