Knowledge HQ

Publications
Publications

G-Rex bioreactors incubated in Heracell™ Vios™ CR CO₂ Incubators help prevent cross contamination and bacterial contamination in cell and gene modified cell therapy production

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.
Download Now
Publications

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.
Download Now
Publications

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.
Download Now
Publications

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.
Download Now
Publications

Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing; Draft Guidance for Industry

This draft guidance outlines how to leverage prior knowledge to advance the development of human gene therapy products incorporating genome editing.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.
Download Now
Publications

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.
Download Now
Publications

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.
Download Now
Publications

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.
Download Now
Publications

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.
Download Now
Publications

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.
Download Now
Publications

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.
Download Now
Publications

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.
Download Now

ScaleReady is a joint venture between Wilson Wolf Manufacturing and Bio-Techne.