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Publications
B Cells, CAR T Cells, T-Cells
G-Rex6M – 2cm²
An Agile Phase I Platform Trial
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.
Publications
T-Cells
G-Rex10M-CS
Clinical-Grade Tumor-Reactive T Cells (TRT) from Antigen-Naïve Healthy Donors and Allogeneic Transplant Recipients
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.
Publications
Other
Q8, Q9, and Q10 Questions and Answers (R5) Guidance for Industry
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.
Publications
CAR T Cells
Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing; Draft Guidance for Industry
This draft guidance outlines how to leverage prior knowledge to advance the development of human gene therapy products incorporating genome editing.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.
Publications
B Cells, CAR T Cells, NK Cells, NKT Cells
G-Rex500M
A streamlined, end-to-end solution for robust and efficient large-scale CART 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
CAR T Cells
G-Rex500M-CS
The CliniMACS Prodigy®: An adaptable, intelligent centerpiece for customizable manufacturing strategies
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.
Publications
CAR T Cells
A Rapid Approach to Streamlined CART Therapies and Reduced Cost of Goods
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.
Publications
TCR T Cells
G-Rex100M, G-Rex6M – 2cm²
Clinical-scale 10-day TCR-T cell manufacturing using IL-2/7/15 and TGF-β promotes early memory and tissue-resident-like phenotypes and robust antitumor activity in vitro
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.
