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RAPID-T: Rapid, Adaptive Production for Improved Decentralised CAR-T delivery

Project ID: 2228cd1265 (You will need this ID for your application)

Under Offer

Research Theme: Manufacturing The Future

UCL Lead department: Biochemical Engineering

Department Website

Lead Supervisor: Qasim Rafiq

Project Summary:

Chimeric Antigen Receptor T cell (CAR-T) therapy is a new type of personalised cancer treatment used to treat patients with blood cancers whose disease is resistant to chemotherapy and who have failed all other therapeutic options. Despite this clinical promise, CAR-T therapies can cost in excess of £300,000 due to the time and complexity of manufacture. Current manufacturing times for CAR-T takes ~9 days with an additional 14-21 days required for the product release testing, and manufacturing costs alone account for ~£95,000 per product.

A rapid, adaptive production solution is required solutions are required to reduce the cost of production, improve product consistency, and improve patient access to this transformative, curative therapeutic modality.

Overall Aim: We aim to establish a faster, more agile CAR-T production process for expedited manufacture and develop adaptive digital tools that enable the shift to autonomous manufacture with the associated controls needed for regulatory compliance to enable the decentralised production.

Building on recent advances in research led by the supervisory team and others internationally, the first key objective of this project will be to develop a 2-day CAR-T manufacturing process. The research approach to establish this expedited production process will be achieved through improved expansion protocols based on perfusion to achieve effective process intensification in addition to improving the transduction and activation steps.

The second key objective of this project is the creation of digital tools, such as digital twins and process models, to enable autonomous, digitally-integrated, disruption-resilient CAR-T production. Leveraging real-time Process Analytical Technology (PAT) such as Raman spectroscopy and capacitance measurements, the focus will be to develop an advanced digital twin that will enable real-time adaptive optimization of CAR-T cell therapy manufacture by accommodating variability in the incoming patient cells and improving the consistency of cell output.