Autologous immunotherapies achieved impressive treatment results in patients with blood cancers. The next-generation personalised immunotherapies include tumour-infiltrating lymphocytes (TIL) to overcome the limitations of adaptive therapy in the treatment of solid tumours. The EU-funded SMARTER consortium aims to develop a first-in-class bioprocessing platform for personalised autologous cell therapies, implementing innovative analytical technologies and smart process control systems. The project exploits the discovery of novel T cell expansion process biomarkers and novel fluorescence spectroscopy sensors for parameter monitoring of TIL biomanufacturing process. The project objective is to build the prototype platform for follow-up development of the commercial scale bioreactor.
Autologous immunotherapies have revolutionised cancer treatment providing impressive survival benefits in patients with blood cancers. The next generation of personalised immunotherapies using tumour-infiltrating lymphocytes (TIL) aims to overcome efficacy limitations of CAR-T therapies in the treatment of solid tumours. Lack of effective, fast, adaptive, controllable, and scalable manufacturing process remains one of the critical bottlenecks for clinical adoption of such complex personalised cell therapies.
In the SMARTER project, Achilles Therapeutics UK Limited (ATX), a clinical-stage company developing autologous cell therapies, partners with the centre of excellence for Cell and Gene Therapy Catapult (CGTC) and academic experts in process biomarker discovery (Instituto de Investigacion Sanitaria La Fe (HULAFE)) and bioprocess sensor development (Leibniz Universitat Hannover (LUH)). The consortium aims to develop a first-in-class, smart bioprocessing manufacturing platform for personalised autologous cell therapies, implementing for the first time in-line process analytical technologies and smart process control systems. The project exploits breakthrough discoveries of novel T cell expansion process biomarkers and development of new fluorescence spectroscopy sensors for real-time monitoring of critical process parameters, to enable adaptive process control of the precision TIL biomanufacturing process. After the project, the prototype R&D platform will be ready for follow-up development of the commercial scale bioreactor in GMP environment.
The SMARTER platform will critically improve production efficiency, reduce overall costs-of-goods (COGS), shorten manufacturing cycle times (shorter vein-to-vein time), decrease batch failures and lead to more consistent and predictable cell therapy product quality. Finally, the innovations will enable clinical implementation of a potential breakthrough personalised adoptive cell therapy for hardest-to-treat solid tumours such as lung cancer and melanoma.
