This cross-sector event was developed by the EPSRC-funded FAST-CAR-T research team, led by Professor Qasim Rafiq (UCL), and marks a significant milestone in driving cross-sector collaboration to accelerate the digitalisation and automation of CAR-T cell therapy and ATMP manufacturing in the UK.

The aim was to explore the potential of digital technologies, automation, and regulatory innovation to overcome existing bottlenecks in CAR-T cell therapy production and enhance readiness for broader ATMP scale-out and commercialisation and improved patient access. 

Why is this important? 

CAR-T cell therapies represent one of the most clinically and commercially advanced forms of cell and gene therapies (CGTs), offering transformative, potentially curative, outcomes for patients with aggressive blood cancers who have exhausted all other treatment options. However, these therapies cost over £300,000 per patient due to the highly complex, time-intensive, and personalised manufacturing processes involved. To fully realise the potential of CAR-T therapies and ensure wider patient access, rapid, adaptive, and scalable manufacturing solutions are urgently needed, as highlighted by Dr Claire Roddie, Consultant Haematologist at UCLH and Associate Professor in Haematology at UCL: 

“Reducing the costs and timelines associated with autologous CAR-T manufacture could have transformative impact for patients, improving both feasibility of treatment and wider access to these ground-breaking therapies.”

Innovation in digital technologies, automation, and regulatory frameworks will be crucial to reducing costs, accelerating production, and enabling greater patient access to these potentially life-saving therapies.

Workshop Highlights

Experts from industry, healthcare, regulation and academia came together for lively debate on the current challenges in scaling CAR-T and ATMP manufacturing, and how digital technologies and regulatory innovation could help advance UK manufacturing.  Some of the key highlights included:

Digital Innovation Opportunities
  • Overcoming persistent bottlenecks: Such as high costs, labour-intensive manual processes, skill shortages, infrastructure limitations, and lengthy production timelines.
  • Logistic complexities: Such as scheduling, cell collection, and maintaining cold chain integrity limit commercial-scale delivery.
     
Digital Innovation Opportunities
  • Digitisation of Quality Management Systems (QMS): Replacing manual, paper-based QMS with integrated digital platforms to streamline workflows, reduce errors, and enable faster batch release.
  • AI: Strong near-term potential to assist with deviation detection, batch tracking, and supporting Qualified Person (QP) led decision-making.
Regulatory Readiness
  • Early engagement: With regulators is essential to co-develop flexible, enabling frameworks for digital and automated manufacturing solutions.
  • Regulatory innovation: Delegates emphasised the need for ongoing regulatory innovation to accelerate approval of digital tools, standardise release assays, and improve access to novel technologies.
Investment and Support Priorities
  • Investment in secure, scalable, and interoperable digital infrastructure to future-proof ATMP manufacturing, alongside the adoption of industry-wide standards to support broader implementation and compliance.
  • Shared infrastructure and public-private partnerships are needed to support SMEs and academic groups who may lack the capacity to implement advanced digital systems.

There was a strong consensus on the need for cross-sector collaboration to co-develop scalable, digital solutions, as explained by Dr Owen Bain, Director  and Qualified Person at the Centre for Cell Gene and Tissue Therapeutics (CCGTT), based at the Royal Free Hospital: 
“What became clear from the workshop is that digitalisation and scalable manufacturing is the key to unlocking the full potential of CAR-T therapies for patients. The innovative approaches and collaborative spirit demonstrated at this workshop are exactly what we need to move from promising treatments for the few to transformative therapies for the many. It was a rare opportunity to interact with all stakeholders including clinicians, developers and even inspectors.”

There was agreement on the strategic value of early and ongoing engagement with regulators to support innovation, and an acknowledgement of the leading role the UK regulators are taking to support growth in this sector.  
 

Future Events

This was the first of a series of workshops exploring different aspects of CAR-T cell therapy manufacturing to be held at venues across the UK, organised by the FAST CAR-T research team.

To find out about upcoming events, please contact the organisers by email via: Helen.Sanderson@uwe.ac.uk.

Quotes

Dr Claire Roddie, Consultant Haematologist at UCLH and Associate Professor in Haematology at UCL 
“Reducing the costs and timelines associated with autologous CART manufacture could have transformative impact for patients, improving both feasibility of treatment and wider access to these ground-breaking therapies.”

Dr Owen Bain, Director /Qualified Person at the Centre for Cell Gene and Tissue Therapeutics (CCGTT), based at the Royal Free Hospital 
“What became clear from the workshops is that digitalisation and scalable manufacturing is the key to unlocking the full potential of CAR-T therapies for patients. The innovative approaches and collaborative spirit demonstrated at this workshop are exactly what we need to move from promising treatments for the few to transformative therapies for the many. It was a rare opportunity to interact with all stakeholders including clinicians, developers and even inspectors.”

Prof Wendy Phillips, Bristol Business School, UWE
“The opportunity is clear: the tools for digitisation already exist, but what’s missing is the infrastructure, interoperability, and regulatory clarity to make them work together. This workshop was a critical step in aligning stakeholders to move forward with purpose.”

Notable Contributions & Speakers

  • Host: Prof. Qasim Rafiq (UCL)
  • Organiser: Dr Helen Sanderson, Prof Wendy Phillips (UWE)

Key Speakers:

  • Dr. Claire Roddie (Royal Free Hospital), Keynote Speaker
  • Prof. Wendy Phillips (UWE)
  • Dr. John Garcia (Royal Free Hospital)
  • Dr. Stephen Goldrick (UCL)

FAST-CAR-T Consortium Partners

  • UCL: Prof. Qasim Rafiq, Dr. Pedro Couto, Dr. Pierre Springuel, Dr. Stephen Goldrick, Syd McLean
  • Royal Free Hospital NHS Foundation Trust: Dr. Claire Roddie, Dr. John Garcia, Dr. Giulia Agliardi, Dr. Juliana Dias Alves Pinto
  • Teesside University: Prof. Gary Montague, Dr. Joseph Egan
  • University of the West of England (UWE): Prof. Wendy Phillips, Dr. Helen Sanderson