Descrizione del progetto
Una piattaforma per portare in pratica clinica i nanofarmaci
I progressi nella nanotecnologia hanno trovato applicazioni nell’industria farmaceutica, avendo un impatto positivo sui pazienti e sulla società in generale. Per favorire ulteriormente la crescita e la capacità di innovazione della nanotecnologia, le strutture di collaudo e produzione devono essere migliorate. Il progetto Phoenix, finanziato dall’UE, mira a favorire il trasferimento dei nanofarmaci dal contesto laboratoriale alla pratica clinica formando un banco di prova per l’innovazione aperta (OITB, open innovation test bed) che rispetti le linee guida regolatorie e di buone prassi di fabbricazione. Phoenix-OITB consisterà in una rete di strutture, tecnologie, servizi e conoscenze sul trasferimento tecnologico per accelerare la produzione e la commercializzazione dei nanofarmaci.
Obiettivo
Nano-pharmaceuticals have the potential to drive the scientific and technological uplift, offering great clinical and socio-economic benefits to the society in general, industry and key stakeholders and patients. Nevertheless, affordable and advanced testing, manufacturing facilities and services for novel nano-pharmaceuticals are main prerequisites for successful implementation of these advances to further enhance the growth and innovation capacity. The establishment of current good manufacturing practice (cGMP) in nano-pharmaceutical production at large scale is the key step to transfer successfully the nano-pharmaceuticals from bench to bedside (from lab to industrial scale). Due to the lack of resources to implement GMP manufacturing at-site, the upscaling and production of innovative nano-pharmaceuticals is still challenging to main players of EU nanomedicine market, start-ups and SMEs. To allow successful implementation of the nano-pharmaceuticals in the nanomedicine field, there is an urgent need to establish science- and regulatory-based Open Innovation Test Bed (OITB). Phoenix aims to enable the seamless, timely and cost-friendly transfer of nano-pharmaceuticals from lab bench to clinical trials by providing the necessary advanced, affordable and easily accessible Phoenix-OITB. Phoenix-OITB will offer a consolidated network of facilities, technologies, services and expertise for all the technology transfer aspects from characterization, testing, verification up to scale up, GMP compliant manufacturing and regulatory guidance. Phoenix-OITB will develop and establish new facilities and upgrade existing ones to make them available to SMEs, starts-up and research laboratories for scale-up, GMP production and testing of nano-pharmaceuticals. The services and expertise provided by the OITB will include production and characterization under GMP conditions, safety evaluation, regulatory compliance and commercialisation boost.
Campo scientifico
Parole chiave
Programma(i)
Invito a presentare proposte
Vedi altri progetti per questo bandoBando secondario
H2020-NMBP-TO-IND-2020-twostage
Meccanismo di finanziamento
IA - Innovation actionCoordinatore
4362 Esch Sur Alzette
Lussemburgo