Descrizione del progetto
Sviluppo di una piattaforma di produzione di biotrasformazione intelligente per terapie cellulari autologhe
Le immunoterapie autologhe hanno ottenuto impressionanti risultati nei pazienti affetti da tumori del sangue. Le immunoterapie personalizzate di nuova generazione prevedono l’uso di linfociti infiltranti il tumore (tumour-infiltrating lymphocytes, TIL) per superare i limiti della terapia adattativa nel trattamento dei tumori solidi. Il consorzio SMARTER, finanziato dall’UE, intende sviluppare una piattaforma di biotrasformazione di prim’ordine per terapie cellulari autologhe personalizzate, implementando tecnologie analitiche innovative e sistemi di controllo dei processi intelligenti. Il progetto sfrutta la scoperta di nuovi biomarcatori del processo di espansione dei linfociti T e di nuovi sensori di spettroscopia di fluorescenza per il monitoraggio dei parametri del processo di biotrasformazione dei TIL. L’obiettivo del progetto è quello di costruire la piattaforma prototipo per lo sviluppo successivo del bioreattore su scala commerciale.
Obiettivo
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, a clinical-stage company developing autologous cell therapies, partners with the centre of excellence for Cell and Gene Therapy Catapult and academic experts in process biomarker discovery (Instituto de Investigacion Sanitaria La Fe) and bioprocess sensor development (Leibniz Universitat Hannover). 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, toa 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, 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.
Campo scientifico
- medical and health sciencesmedical biotechnologygenetic engineeringgene therapy
- medical and health sciencesclinical medicineoncologylung cancer
- medical and health sciencesclinical medicineoncologyskin cancermelanoma
- medical and health sciencesbasic medicineimmunologyimmunotherapy
- medical and health sciencesmedical biotechnologycells technologies
Parole chiave
Programma(i)
- HORIZON.3.1 - The European Innovation Council (EIC) Main Programme
Argomento(i)
Invito a presentare proposte
HORIZON-EIC-2021-PATHFINDERCHALLENGES-01
Vedi altri progetti per questo bandoMeccanismo di finanziamento
HORIZON-EIC - HORIZON EIC GrantsCoordinatore
30167 Hannover
Germania