In this insightful interview with Martin Westberg, Vice President and General Manager of Cell Therapy at Cytiva, BioPharma BoardRoom delve into the transformative advancements brought by the Sefia platform. Martin discusses how this innovative technology, developed in collaboration with Kite, is tackling the longstanding challenges of autologous CAR T cell therapy manufacturing. From enhancing scalability and reducing manual intervention to seamlessly integrating advanced digital monitoring, the Sefia platform is setting new standards in the industry. Join us as we explore how these developments are paving the way for more efficient, cost-effective, and high-quality cell therapies.

Could you elaborate on the specific challenges that have historically hindered patient access and adoption of autologous CAR T cell therapies, and how the Sefia platform addresses these challenges?

The autologous CAR T cell therapy workflow has historically relied on manual labor, making it difficult to scale and meet increasing patient demand for these therapies. The Sefia Platform was developed to automate the cell therapy manufacturing workflow by using a modular and digitally integrated platform which combines two functionally closed systems (together with single use kits and dedicated applications). The Sefia Select system automates cell isolation, harvest and formulation steps, while Sefia expansion system automates cell activation, transduction and cell expansion steps. It was developed to provide robust flexibility and scalability and to limit the need for operator touchpoints.

How does the modular approach and automation featured in the Sefia platform improve the scalability and efficiency of cell therapy manufacturing compared to traditional manual methods?

The Sefia Platform combines two functionally closed systems (together with single use kits and dedicated applications). The Sefia Select system automates cell isolation, harvest and formulation steps, while Sefia expansion system automates cell activation, transduction and cell expansion steps. The systems are ground-up designed specifically for cell therapy manufacturing, and their flexibility lends them very well to a very large range of process parameters. The automation features and the real time monitoring in the Sefia platform were designed to help reduce the risk of bath failures – a pain point in the manufacturing process – from human touchpoints and to help with consistency in the drug developer’s process. 

With the increasing demand for cell therapies and the complexity of manufacturing, how does the Sefia platform contribute to meeting this demand while maintaining quality and safety standards?

The Sefia platform was designed to help accelerate the development and manufacturing of autologous CAR T cell therapies. It’s a functionally closed system that automates certain steps in the workflow and reduces the need for operator intervention and potential errors which has contributed to the high cost of manufacturing. Depending on the workflow and manufacturing set up, the flexibility of the modular design can decrease hardware redundancy and allow for more efficient utilization of cleanroom space. Furthermore, the Sefia cell manufacturing’s open design and architecture enables customers to define their own process parameter groups to meet specific process requirements. 

Can you discuss any notable advancements or improvements in productivity achieved with the Sefia platform compared to previous manufacturing processes?

Designed for seamless adoption into a workflow to increase scalability and flexibility, the Sefia platform was developed to increase productivity by up to 50% in manufactured doses per year as compared to industry standard processes.

You mentioned a collaboration with Kite, a Gilead Company, in developing the Sefia platform. Could you explain the significance of this collaboration and how it has contributed to the platform's innovation and effectiveness?

The Sefia cell therapy was developed as part of a collaboration with Kite, a Gilead company, and a leader in autologous CAR T cell therapy. It has helped our organization better understand the needs of the industry and how to better design the technologies and solutions needed to scale-up and manufacture at commercial scale. Cytiva believes solving the challenges with scaling up and industrializing cell therapy are best solved by collaboration between parties in the sector, which this collaboration exemplifies.

How does the integration of Chronicle automation software with the Sefia platform enhance monitoring of manufacturing operations and manage supply chain logistics, and what benefits does this integration provide to cell therapy developers and manufacturers?

Chronicle software provides a digital record for many procedures that previously relied on manual labor. For example, real time instrument and data monitoring with instant alarm notifications, Electronic Standard Operating Procedures (eSOPs) and Electronic Batch Manufacturing Records (eBMRs) which will enable release by exception are all provided by Chronicle. Additionally, there is a centralized creation, approval and deployment of parameter groups on to the connected Sefia instruments, as well as batches scheduling including consumables, products, instruments and operator bookings. It is also equipped with a QR-code generator which will enable customers to track chain of custody as well as used equipment and consumables through the process.