Projektbeschreibung
Eine Plattform bringt Nanopharmazeutika in die klinische Praxis
Fortschritte der Nanotechnologie haben inzwischen Anwendungen in der pharmazeutischen Industrie gefunden, wo sie nicht nur den behandelten Personen nützen, sondern auch der gesamten Gesellschaft. Um Wachstum und Innovationsfähigkeit der Nanotechnologien weiter zu steigern, müssen die Test- und Fertigungsanlagen verbessert werden. Das EU-finanzierte Projekt Phoenix will die Übernahme von Nanopharmazeutika aus den Testreihen in die klinische Praxis durch ein Prüffeld ermöglichen, das im Sinne der offenen Innovation konzipiert ist, die regulatorischen Richtlinien einhält und den guten Arbeitspraktiken entspricht (kurz: OITB). Das Phoenix-OITB wird aus einem Netzwerk aus Einrichtungen, Technologien, Dienstleistungen und Expertise im Technologietransfer bestehen, das die Produktion und Kommerzialisierung von Nanopharmazeutika vorantreiben soll.
Ziel
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.
Wissenschaftliches Gebiet
Schlüsselbegriffe
Programm/Programme
Aufforderung zur Vorschlagseinreichung
Andere Projekte für diesen Aufruf anzeigenUnterauftrag
H2020-NMBP-TO-IND-2020-twostage
Finanzierungsplan
IA - Innovation actionKoordinator
4362 Esch Sur Alzette
Luxemburg