Descripción del proyecto
Desarrollo de una plataforma de fabricación de bioprocesamiento inteligente para terapias celulares autólogas
Las inmunoterapias autólogas lograron impresionantes resultados de tratamiento en pacientes con neoplasias hemáticas. Las inmunoterapias personalizadas de nueva generación incluyen linfocitos infiltrantes tumorales (LIT) para superar las limitaciones de la terapia adaptativa en el tratamiento de los tumores sólidos. El consorcio SMARTER, financiado con fondos europeos, pretende desarrollar una plataforma de bioprocesamiento de primera clase para terapias celulares autólogas personalizadas, aplicando tecnologías analíticas innovadoras y sistemas de control de procesos inteligentes. El equipo del proyecto aprovecha el descubrimiento de nuevos biomarcadores del proceso de expansión de los linfocitos T y nuevos sensores de espectroscopia de fluorescencia para el seguimiento de los parámetros del proceso de biofabricación de LIT. El objetivo del proyecto es construir la plataforma prototipo para el desarrollo posterior del biorreactor a escala comercial.
Objetivo
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.
Ámbito científico
- 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
Palabras clave
Programa(s)
- HORIZON.3.1 - The European Innovation Council (EIC) Main Programme
Tema(s)
Convocatoria de propuestas
HORIZON-EIC-2021-PATHFINDERCHALLENGES-01
Consulte otros proyectos de esta convocatoriaRégimen de financiación
HORIZON-EIC - HORIZON EIC GrantsCoordinador
30167 Hannover
Alemania