ISCT 2025 takeaways

Sarah de la Mota, Business Development Specialist, Limula:
A clear theme at ISCT this year was the growing shift toward decentralized and point-of-care manufacturing models in cell and gene therapy. While definitions of these terms are still evolving and can cause confusion, the core idea remains the same: bringing manufacturing closer to the patient for a more efficient circular supply chain. 

Decentralization was described as a spectrum and can take many forms, from local processing of starting material to full production within hospitals. The goal is to reduce costs, increase flexibility, and improve access, especially for rare diseases and patients in hard-to-reach areas. Point-of-care manufacturing also drew attention. Hospitals and research centers are building their own GMP spaces and partnering with technology providers to reduce costs and increase autonomy. These efforts, combined with greater standardization, are helping reduce vein-to-vein time.

That said, challenges remain. Success depends on early investment in strong quality systems, centralized data management, and robust automation. Many speakers stressed automation must be built in early. Waiting too long can limit scalability and increase long-term costs.

In short, centralized manufacturing still has its place, but decentralized approaches are gaining momentum. With the right tools, infrastructure, and regulatory support, they could be key to making advanced therapies more accessible worldwide.

Mark Flower, VP of Business Development, Cell and Gene Technologies, AGC Biologics:
One of the many benefits of attending ISCT is the wide variety of discussions and panels. The panel titled “Building a New Processing Facility: Plans, Challenges and Solutions” was a real-world, practical review with lessons learned.

My takeaways: Planning is critical. Understand what services you plan to provide, what equipment you’re going to need, and consider the future. Using a consultant or contractor with significant experience is better than going it alone. Personnel are also a crucial component. Recognize that talent will impact your success. Determine up front where your staff will come from, recruiting isn’t easy, and can you identify and train internal talent? Onboarding, training and continuing education should be considered and incorporated into early facility planning.

Equipment considerations are key budgetary considerations. Capital expenses like processing and manufacturing technologies can make or break a budget. In the words of Ronit Slotky, Director of Cell Therapies Manufacturing Facility at Hackensack University Medical Center, “Don’t buy equipment you don’t need.”

The progress being made using CAR-T cells to treat autoimmune disease is real, and cause for optimism. Fabian Mueller from FAU Erlangen-Nürnberg presented positive clinical data from 35 autoimmune patients treated as of September 2024. He noted that there is very little acute toxicity from CA-T cell treatments, and the incidence of severe infections is very low.

One caveat: The numbers of patients treated is still small. And in a final slide, provided an update on patient #1 (treated by Georg Schett at Uniklinikum Erlangen almost four years ago) who is still lupus-free, and back to a normal life.

Ry Leahy, VP of Research & Strategic Partnerships, Phacilitate:
ISCT is a pivotal touchpoint for meeting leaders in the field of cell therapy, and exploring the biggest challenges and bottlenecks, and mapping out potential solutions.

ISCT and ASGCT both featured BBG's first-ever mobile leukapheresis center on the show floor, fully-decked out mobile laboratory and two apheresis collection stations. This initiative has a view to expand access to cellular therapies for South Texas, and prioritizes patient comfort and accessibility as well as operational reach, aligning with BBG's broader commitment to enhancing patient care and access to life-saving therapies.

Read the ASGCT Annual Meeting takeaways