Partnership Cuts Cost of CAR T Manufacturing
Manufacturing bottlenecks remain a key hurdle in CAR-T therapy. Can automation and digital integration change that? Trenchant and Autolomous explore the possibilities.
| 4 min read | Interview
CAR T manufacturing has long been plagued by high costs, inefficiencies, and scalability challenges. A new partnership between Trenchant BioSystems and Autolomous aims to change that by targeting an eightfold improvement in cell processing efficiency and an 80 percent reduction in costs. But how feasible is this approach, and what does it mean for the future of cell and gene therapy? Trenchant CEO Jon Ellis and Autolomous CEO Alexander Seyf explain.
An eightfold improvement in cell processing efficiency seems like quite the accomplishment. How did you achieve this?
JE: Our approach was not to incorporate inefficient, legacy technologies but rather to develop and integrate novel modules that can minimize cell loss and improve efficiency during washing, selection, activation, and transduction. The gains we can achieve during these unit operations allow us to eliminate the need for expansion. An eightfold improvement in processing is merely the sum of all these benefits.
And the 80 percent reduction in CAR-T manufacturing costs?
JE: The end to end, closed automated platform enables CAR-T manufacturers to optimize cost savings in facilities because it is designed to operate in more cost-efficient class C and D cleanrooms. It begins with the input of whole blood or apheresis and ends with a CAR-T dosage within the same platform, decreasing the number of platforms needed to a single one. This is compared to the traditional process where multiple platforms would be required to achieve the same cell therapy dosage.
Elsewhere, our reagents and single-use systems are designed to be highly cost effective, while the partnership with Autolomous helps digitize batch records and process control to enable release by exception – vastly reducing the number of hours that the quality team needs to dedicate to this task. Release by exception reduces the number of full-time employees required in quality assurance, and the automation present means that no specialist lab scientists are required.
AS: The integrated platforms enable automated data collection, analysis, and reporting, minimizing the need for manual review and interpretation, which reduces the reliance on specialized personnel for data analysis and quality control. Automation helps standardize manufacturing processes, reducing variability and the potential for human error, which leads to more consistent product quality and simplifies the review and release process.
How exactly does Autolomous' technology integrate with Trenchant's automated manufacturing platform?
AS: The partnership creates a fully digitized and interconnected – and therefore enhanced – manufacturing process with real-time monitoring and control, automated data capture and analysis, streamlined workflows, enhanced quality control, and improved traceability. By combining automation, digitization, and real-time analytics, the partnership is driving innovation and efficiency in the CGT sector.
How does the partnership align with sustainability, scalability, and accessibility goals in the CGT sector?
AS: By automating and optimizing the manufacturing process, we can significantly increase production capacity for CAR-T cell therapies. Furthermore, by streamlining processes and reducing labor needs, we can lower the overall cost of CAR-T cell therapy. The ultimate aim is to enable decentralized manufacturing so that CAR-T cells can be produced closer to patients, reducing logistical challenges and improving access for those in remote or underserved areas.
When it comes to sustainability, automated manufacturing processes can significantly reduce resource consumption and minimize waste. This includes optimizing the use of materials, energy, and water. The increased efficiency achieved through streamlined workflows and reduced manual intervention translates to a lower environmental footprint. Data analytics also provide insights into resource utilization, enabling data-driven decision-making to further improve sustainability performance and identify areas where environmental impact can be minimized.
How do you envision the partnership evolving in the future?
AS: This partnership was born from a shared vision to improve patient access to CAR-T cell therapies. We recognized the potential for significant advancements by combining expertise in automation software with cutting-edge manufacturing technology. This synergy allows us to address key challenges in CAR-T cell production, such as scalability and cost-effectiveness.
Looking ahead, we envision this collaboration deepening in several ways. We plan to further integrate software and hardware platforms, develop new features that streamline workflows and enhance quality control, and expand our reach into new markets. This will allow us to bring the benefits of these life-saving therapies to more patients worldwide.
Are there plans to expand this integrated platform to other types of cell and gene therapies beyond CAR-T?
JE: Yes, the Trenchant platform can be utilized to manufacture therapies from a variety of cell types. Early data has been generated for NK and CD34+ cells, with encouraging results.
AS: The CGT field is constantly evolving, and we want to support that growth. While we've initially focused on CAR-T cell therapies, our platform is modality and vendor agnostic. This means it can readily accommodate other CGT types as they emerge. Our partnership strengthens this commitment to openness and adaptability, ensuring we can cater to the diverse needs of the industry.
