George White is the General Manager of Cell Therapy at Cytiva, a global biomanufacturing organization headquartered in the U.S. and part of Danaher.
In this Q&A with Biopharma Reporter, White discusses current and future trends in cell therapy manufacturing and how automation and collaboration are key to getting cell therapies to patients in need.
What are the most significant trends you are currently observing in biomanufacturing, particularly concerning cell therapy and biologics?
More than 1,000 clinical trials are currently underway globally for cell therapies and several autologous chimeric antigen receptor (CAR)-T cell therapies are now being prescribed as second-line treatment. There is also a lot of ongoing research to develop allogeneic cell therapies or “off-the-shelf” therapies.
With this increased demand comes the need for more flexible and automated manufacturing processes and equipment that will allow manufacturers to scale up quickly.
How is Cytiva leveraging automation to enhance efficiency and scalability in cell therapy manufacturing?
Cytiva recently launched the Sefia cell therapy manufacturing platform, which was developed in collaboration with Kite Pharma, to automate the cell therapy workflow.
Sefia uses a modular and digitally integrated platform, combining two functionally closed systems: the Sefia Select system and the Sefia expansion system (together with single-use kits and dedicated applications).
The Sefia Select system automates cell isolation, harvest, and formulation steps, while the Sefia expansion system automates cell activation, transduction, and cell expansion steps.
The Sefia cell therapy manufacturing platform is designed to be flexible and to increase manufactured doses by up to 50% per year compared to standard industry processes. The platform’s automation features and real-time monitoring features were designed to limit the human touchpoints and help with consistency in the process.
Additionally, depending on the workflow and manufacturing setup, the flexibility of the modular design can decrease the need for hardware and allow for more efficient utilization of cleanroom space.
At Cytiva, we work closely with and listen to our customers so we can deliver the technologies and solutions needed to manufacture these advanced therapies.
Looking ahead, what do you envision for biomanufacturing in the near future? What innovations do you believe will have the most significant impact?
The future of biomanufacturing makes me feel hopeful and excited for all the patients who stand to benefit from advanced therapies. Every day, we work closely with our customers, enabling them to deliver these novel therapeutics to patients, especially with fit-for-purpose manufacturing technologies and solutions. Our Sefia cell therapy manufacturing platform is designed to increase productivity by up to 50% which will help manufacturers meet the growing demand for cell therapies.
The research that is being done to see if and how cell therapies can treat solid tumors and autoimmune diseases is also very exciting. We must keep working to automate and industrialize the manufacturing processes so they are robust and can meet the patient demand.
Can you discuss any partnerships or collaborations Cytiva is pursuing to advance biomanufacturing technologies? How do these collaborations align with the needs of the industry?
At Cytiva, we are always working in collaboration with our customers to develop the tools and technologies needed to deliver advanced therapies. We understand that many patients are waiting for advanced therapies and that we play an important role in enabling our customers to deliver those therapies to patients in their time of need.
The Sefia cell therapy manufacturing platform, for example, was developed by Cytiva as part of its collaboration with Kite, a Gilead company, that is pioneering the development of autologous CAR-T cell therapies.
We are also collaborating with Bayer, where Cytiva is developing a manufacturing platform for allogeneic cell therapies. While we have deep expertise in manufacturing, we know that collaboration across the industry is needed to develop the tools and technologies that will enable our customers to deliver advanced therapies.
What initiatives is Cytiva undertaking to promote sustainability within biomanufacturing processes, and how do you see these efforts evolving in the future?
Sustainability is a fundamental part of how we conduct business at Cytiva. We are committed to net zero greenhouse gas emission targets. We do this by leading with eco-design and product transparency, accelerating decarbonization across the value chain (customers and suppliers), and building a culture of sustainability across the business.
What key insights or best practices would you recommend to other manufacturers looking to enhance their production capabilities in the current biopharma landscape?
One thing I would advise is to plan how to scale your therapy at the earliest opportunity. You don’t want to risk designing a process that doesn’t scale up or out. It’s costly and it delays the delivery of advanced therapies to the patients who need them most.
