Advanced Therapies Week 2025: Decentralized Manufacturing and Point of Care

At Advanced Therapies Week 2025, the afternoon session on decentralized manufacturing and point-of-care cell therapy presented pioneering approaches to overcome long-standing challenges in accessibility, affordability, and manufacturing logistics of chimeric antigen receptor T-cell therapies. The discussion centered on three expert speakers, Ian Gaudet from Galapagos, Dr. Marcos de Lima from Ohio State University, and Lee Buckler from Blood Centers of America, who shared innovative strategies and clinical data supporting decentralized models that bring manufacturing closer to patients, thereby reducing turnaround times and costs.

Ian Gaudet introduced Galapagos’ decentralized manufacturing platform that produces fresh, stem-like CAR-T cells within a median 7-day vein-to-vein time, bypassing the need for cryopreservation. Their closed, automated Cocoon system coupled with the xCellit digital platform enables real-time process monitoring and quality control, helping ensure consistent product quality across multiple decentralized sites. Early clinical data demonstrated high response rates, manageable safety profiles, and durable remissions in lymphoma patients, highlighting the clinical and economic benefits of rapid manufacturing and fresh cell infusion.

Dr. Marcos de Lima discussed a complementary approach focusing on a fast 20-hour manufacturing process that eliminates cell isolation and expansion steps, aiming to preserve stemness and reduce costs. He presented promising Phase 1 clinical results with a strong response rate and low toxicity, underscoring the feasibility of extremely rapid CAR-T generation that may expand access globally. Dr. de Lima emphasized the necessity of reducing cost as the critical factor in broadening CAR-T therapy accessibility, especially in resource-limited settings.

Lee Buckler provided a broad perspective on decentralized manufacturing’s role within the evolving ecosystem, emphasizing that no single model will suffice. He highlighted Blood Centers of America’s infrastructure and regulatory experience as a platform for decentralized manufacturing and supply chain networks capable of supporting regional and national demand. Buckler stressed the importance of digitization, automation, and regulatory readiness as pillars for scaling decentralized manufacturing globally. He also underscored the need to create cost-effective, smaller-footprint manufacturing units that can be deployed at community hospitals, expanding therapy access beyond specialized cancer centers.

Together, the ATW 2025 panelists painted a comprehensive picture of a rapidly evolving CAR-T therapy landscape where decentralization, automation, digital oversight, and innovative manufacturing workflows coalesce to improve patient access, reduce costs, and sustain treatment efficacy and safety. They underscored that overcoming logistical, technical, and regulatory challenges through collaboration and technological innovation is essential to democratize these therapies globally.

Highlights

• Galapagos achieves a median 7-day vein-to-vein manufacturing cycle using a decentralized, automated platform delivering fresh CAR-T cells.
• Dr. de Lima presents a novel 20-hour CAR-T manufacturing process that preserves T-cell stemness and shows strong Phase 1 response.
• Blood Centers of America leverage their network and regulatory expertise to support decentralized manufacturing, improving access across the US.
• Integration of digital platforms like xCellit enables real-time process monitoring and quality control in decentralized settings.
• Closed, automated systems such as Cocoon reduce reliance on cryopreservation and complex logistics, lowering overall costs.
• Emphasis on cost reduction as the critical factor for global CAR-T accessibility, especially in lower-income countries.
• The future of CAR-T manufacturing is moving toward miniaturized, automated, localized production units deployable at community and hospital sites.

Key Insights

• Decentralized Manufacturing as a Game Changer: Centralized CAR-T manufacturing has inherent limitations that restrict access. Galapagos’ decentralized approach, demonstrated by a median 7-day cycle, reduces barriers by producing fresh cells near the patient, eliminating cold chain dependencies and enabling rapid treatment.
• Automation and Digital Integration are Critical Enablers: Robust automation and digitization underpin success. xCellit enables end-to-end data management, real-time monitoring, and electronic batch records that support technology transfer and consistency across sites.
• Rapid Manufacturing Preserves Cell Fitness: Both Galapagos’ 7-day and de Lima’s 20-hour workflows focus on preserving an early stem-like T-cell phenotype associated with better proliferation, efficacy, and durability. Shorter manufacturing can enhance potency and reduce toxicities.
• Cost Reduction is the Linchpin: Meaningful cost reduction must accompany technical innovation to broaden access worldwide. Decentralization shortens timelines, can reduce bridging therapy, and leverages automation to lower labor and facility costs.
• Diverse Models Will Coexist: Hospital-based, blood center-based, and automated bedside systems will coexist depending on regional infrastructure and regulatory environments. Integration with community settings is essential to reach underserved populations.
• Regulatory and Institutional Readiness: Adoption depends on frameworks that accommodate distributed production without compromising safety and quality. Training, infrastructure, and digital system integration are critical for scale.
• Miniaturization and Localization: The field is moving toward push-button, closed-system platforms in localized settings, reducing time to treatment and enabling more personalized therapies.

Detailed Analysis

Patient Access and Unmet Need
Centralized manufacturing of autologous CAR-T therapies faces capacity limits, cryopreservation logistics, and long vein-to-vein times. The decentralized paradigm presented at Advanced Therapies Week 2025 addresses these issues by producing fresh, rapid-turnaround products near clinical sites, expanding the pool of patients who can be treated in a timely fashion.

Technological Innovation in Manufacturing Platforms
Galapagos’ Cocoon platform is an automated, closed, single-use cassette-based bioreactor enabling standardized, contamination-resistant manufacturing within a small footprint. Paired with xCellit for scheduling, batch records, QC, and clinical data, it supports transparency and streamlined operations across a distributed network.

Clinical Efficacy and Safety of Fresh CAR-T
Early clinical data show strong responses with durable remissions in lymphoma cohorts alongside favorable safety profiles. The fresh cell product’s stem-like phenotype correlates with in vivo expansion and persistence, which support durable response and may enable more outpatient care.

Rapid Manufacturing Workflow and Stemness Preservation
Dr. de Lima’s 20-hour manufacturing process bypasses traditional isolation and expansion steps, preserving T-cell stemness and enabling rapid availability of CAR-T products. Early results indicate high remission rates with manageable toxicity, while sharply decreasing manufacturing costs.

Supply Chain and Network Infrastructure
Blood Centers of America’s apheresis and processing network, combined with regulatory and quality management expertise, provides a decentralized manufacturing ecosystem. These assets can facilitate regional hubs near clinical centers, reducing delays and supporting integration with automated technologies and digital quality oversight.

Regulatory and Market Considerations
Agencies are defining pathways that accommodate decentralized manufacturing while maintaining safety and consistency. Institutional readiness varies, necessitating strong training programs and quality systems to harmonize operations across sites. Education and awareness remain essential to ensure eligible patients are referred for CAR-T.

Future Prospects and Challenges
Standardizing analytical assays, managing variability in starting material, training personnel, and ensuring global regulatory compliance remain priorities. Extending these therapies beyond oncology underscores the need for scalable, flexible manufacturing solutions, supported by multi-stakeholder collaboration.

Speakers:

• Brian Hanrahan – VP of Business Development, Planet Innovation (Chair)
• Ian Gaudet – Head of US Tech Ops, Galapagos
• Marcos de Lima – Director, Stem Cell Transplant & Cellular Therapy, Ohio State University Medical Center
• Lee Buckler – SVP, Advanced Therapies, Blood Centers of America

Conclusion
This Advanced Therapies Week 2025 session underscored the potential of decentralized manufacturing to reduce production times, enhance quality, lower costs, and expand access. Automated platforms, integrated digital oversight, and partnerships with blood centers and healthcare institutions are central to this vision. While challenges remain, the models presented point toward a decentralized, digitized, and democratized future for CAR-T therapies.