Design, Transfer and Qualification of a Commercially-Scalable Manufacturing Process for CAR-T cells

Chimeric Antigen Receptor therapies (CAR-T), represent an entirely new, potentially transformative approach to treating cancer. They combine the precision of a monoclonal antibody with the potency and persistence of the human immune system. Researchers in the USA have recently reported clinical data using CAR-T in blood cancers which are causing great excitement within the medical community. High response rates are being achieved even in those patients who have proved refractory to previous treatments. Autolus, a UK spin-out company from UCL, has proprietary technology which could broaden the application of CAR-T therapies beyond liquid cancers and into common, solid tumour types. However, CAR-T products are complex, personalised advanced therapy medicines (ATMPs) and consequently require a correspondingly complex manufacturing process. For these pioneering therapies to become viable, accessible medicines; there will need to be innovation in the manufacturing technology. The project will combine leading UK expertise to develop and demonstrate a scalable, commercially-viable manufacturing process for CAR-T therapies.