Enhancing cell therapy manufacturing with the CGX10 Cell Isolation System

Cell and gene therapies are revolutionizing medicine, offering curative potential for previously untreatable diseases. However, manufacturing these therapies often demands complex, time-consuming, and resource-intensive processes, and innovative technologies are therefore required to streamline workflows and improve efficiency. At Stanford’s Laboratory for Cell and Gene Medicine (LCGM), advanced automation tools like the CGX10 Cell Isolation System are reshaping the future of cell therapy manufacturing.¹

Improving cell sorting for precision therapies

The LCGM is a state-of-of-the-art GMP manufacturing facility that supports the production of clinical cell therapy products for Phase 1 and 2 trials. Spanning 23,000 square feet, the site is equipped with multiple cleanrooms for cell therapy manufacturing and viral vector production, as well as a dedicated space for process development. One of the facility’s recent technological advancements has been the addition of the CGX10 Cell Isolation System, which enables precise selection and isolation of cell populations for therapeutic applications.

Alex Anneling, Clinical Manufacturing Manager at the LCGM, explained: “Most of the products that we manufacture are derived from apheresis products: mononuclear cells collected from patients or donors. We isolate specific cell populations – such as CD34 stem cells, CAR-T cells, and CD4+ and CD8+ T cells – from these samples to create products tailored to individual patient needs. Previously, we relied solely on magnetic bead-based technologies to isolate these cells, but the addition of the CGX10 has significantly refined this process, enabling precise targeting and sorting of very specific cell subsets.”

Streamlining workflows with automation

Cell therapy manufacturing can be conducted using either an open or closed system. Open systems are commonly used in research settings, due to their simplicity and low costs, but they typically involve extensive operator input and documentation at every stage, significantly increasing manual workloads. In contrast, closed systems minimize contamination risks, ensure regulatory compliance, and streamline resource-intensive process steps by reducing the need for manual sample handling.

The CGX10 is a fully closed system offering advanced automation capabilities that address the challenges associated with open systems. “The CGX10 is compatible with tubing sets used across both upstream and downstream workflows,” Alex continued. “This allows sterile welding of containers directly onto the tubing kit, eliminating the need for manual sample transfers. Operators can simply set up the kit, load the cells, and walk away while the machine runs independently. This approach not only saves time and frees up the operator to focus on other tasks, but also eliminates much of the documentation burden associated with open systems.”

Enhancing efficiency and ensuring compliance

By combining automation, a user-friendly interface, and compliance-focused features, the CGX10 offers a comprehensive solution that enhances productivity and confidence in manufacturing workflows. These features enhance efficiency for the LCGM team and make the CGX10 an ideal solution for GMP facilities. “The CGX10’s software navigation wizard guides operators step-by-step through the setup and operation process,” Alex noted. “This ease of use significantly reduces training time and minimizes the potential for user errors, making the system accessible even to less experienced operators. Automation also ensures reproducibility between batches regardless of the operator, which is important for ensuring consistent therapeutic outcomes. Crucially, the system includes robust controls – such as user-specific access credentials – to ensure accountability and secure documentation. Operators can generate and manage sorting reports easily, providing detailed records to confirm the sorted product meets compliance standards. Combined with accessible on-screen guidelines and help manuals, these features streamline operations while adhering to stringent regulatory requirements.”

Accelerating research and expanding applications

The CGX10’s advanced capabilities are driving innovation in targeted cell therapies, enabling a more refined approach to treatment. Instead of administering bulk CAR-T cells, future therapies may involve selecting specific subsets of CAR-T cells tailored to individual patients. Similarly, for stem cell therapies, the ability to sort beyond CD34 to isolate naive stem cells opens possibilities for improving therapeutic outcomes like engraftment. One notable example where the CGX10 is helping to drive progress is in the work led by Dr Irving Weissman, Professor of Pathology and Developmental Biology at Stanford University. “We’ve been collaborating with Dr Weissman to develop a purified stem cell product for women with metastatic breast cancer, and the CGX10 has been instrumental in advancing this project. The level of sorting precision for this type of application is where the CGX10 truly shines,” Alex commented.

Looking to the future

Looking ahead, the LCGM team anticipates even greater automation in cell therapy manufacturing. “In the next three years, I expect a significant shift towards automation, with robotic systems handling tasks like media exchanges and cell transfers,” Alex predicted. “The CGX10 positions us to stay ahead of these advancements, enabling the development of more potent and precise therapies. With this system, we’re not just enhancing our own capabilities but also making cell therapy more accessible and impactful for patients worldwide.”

Watch the Full Video Interview

Alex Anneling
Clinical Manufacturing Manager
Laboratory for Cell and Gene Medicine, Stanford University
California, USA