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For Cell and Gene Modified Cell Therapy (CGT) manufacturing, a robust contamination control strategy (CCS) is necessary to ensure compliance with current Good Manufacturing Practices (cGMP). A successful CCS helps ensure safety, purity, efficacy, and quality of a CGT product. CGT manufacturers should implement Closed Systems wherever possible and employ equipment that maintains a stable, clean environment with advanced monitoring. We show that Closed System G-Rex® bioreactors combined with Thermo ScientificTM HeracellTM ViosTM CR carbon dioxide (CO2) incubators enable simplified parallel processing capabilities and significantly reduced contamination risks in a highly efficient production.

Rizwan Chaudrey spoke with Ignacio Núñez, COO, CellReady, at ISCT 2024  about the company, its relationship with ScaleReady, what they are showcasing tat ISCT and what makes them unique.

In this application, the health of Triple Knock-Out (KO) transfected T-cells was evaluated by measuring cell expansion and viability in a Gas Permeable Rapid Expansion (G-Rex® - Wilson Wolf Manufacturing, LLC) platform using different cell culture media and cytokine supplement.

The G-Rex® Grant Program is empowering CGT manufacturers with resources and expertise and is a $20 million initiative by ScaleReady, Wilson Wolf Manufacturing, Bio-Techne, and CellReady, that is designed to propel the advancement of cell and gene therapies (CGT).  If you’re engaged in pre-clinical research, process development, or cGMP manufacturing of cell and gene-modified cell therapies, this program is for you!

Review the official description and outline of the new G-Rex® Grant Program, which empowers CGT manufacturers with resources and expertise. This $20 million initiative by ScaleReady, Wilson Wolf Manufacturing, Bio-Techne, and CellReady is designed to propel the advancement of cell and gene therapies (CGT).

Multiply Labs, a robotics company developing industry-leading automated manufacturing systems to produce individualized drugs, and Wilson Wolf, an innovative leader in cell and gene-modified cell (CGT) manufacturing technology, today announced a collaboration around the automation of Wilson Wolf’s G-Rex® bioreactors.

To better optimize their manufacturing process for a current clinical trial and IND amendment, AgonOx and Providence began to look for products to close and streamline key portions of the established manufacturing process for a shared project. It was imperative to find products that would maintain established levels of cell recovery, viability, and efficacy.

CAR-T cell therapy has emerged as a powerful weapon in the fight against specific B-cell malignancies. Its success has fueled significant research efforts to broaden its reach to encompass a wider range of hematologic and solid tumors.    Optimizing CAR-T cell therapy hinges on a deeper understanding of the intricate signaling pathways that govern these potent immune cells. This includes their ability to infiltrate tumors, evade antigen escape mechanisms, resist immunosuppression, and minimize potentially fatal toxicities. To achieve this, researchers require a comprehensive characterization of the signaling molecules involved, encompassing the extracellular, membrane-bound, and intracellular compartments. However, this endeavor is often hampered by limited and complex sample types.    The Wilson Wolf G-Rex platform offers a unique solution for large-scale expansion of CAR-T cells, enabling researchers to study these vital communication networks within larger, more robust cell populations. This facilitates a deeper understanding of CAR-T cell function and paves the way for the development of safer and more effective CAR-T therapies.    Unleash the Full Potential of CAR-T Cells: Learn More  Understanding these vital communication networks within CAR-T cells is critical to unlocking their full potential. Download our free App Note: Analytical Tools to Evaluate CAR-T Cell Signaling & Activation to explore the latest advancements in research methods for optimizing CAR-T cell therapy. 

Current methods of final formulation fill and finish either require manual processing which has the potential to result in operator error, or utilized automated systems with limited capabilities. Manual methods or semi-automated systems may present the risk of increased exposure time of cells to DMSO within the cryoprotectant, causing a reduction in post-thaw viability and recovery. The Cue Cell Processing System is a functionally closed and fully automated instrument with enhanced system functionalities for F/F/F of Cell and Gene therapy products

G-Rex bioreactors from Wilson Wolf are designed to be used in a "fill-and-forget" manufacturing workflow with Bio-Techne reagents and cytokines. During T-cell expansion, manual interventions for media change and cytokine supplementation can be eliminated. This reduces the risk of contamination and greatly streamlines manufacturing workflows while reducing reagent and overhead costs.