Description du projet
Une plateforme pour acheminer les produits nanopharmaceutiques au chevet des patients
Les progrès des nanotechnologies ont trouvé des applications dans l’industrie pharmaceutique, avec des répercussions bénéfiques pour les patients et plus généralement pour la société. Pour renforcer davantage la croissance et la capacité d’innovation du domaine des nanotechnologies, il convient d’améliorer les installations d’essai et de fabrication. L’objectif du projet Phoenix, financé par l’UE, consiste à faciliter le passage des produits nanopharmaceutiques du laboratoire au chevet du patient, en mettant en place un banc d’essai d’innovation ouverte (OITB, pour «open innovation test bed») conforme aux directives réglementaires et aux bonnes pratiques de fabrication. Phoenix-OITB prendra la forme d’un réseau d’installations, de technologies, de services et d’expertise en matière de transfert de technologie visant à accélérer la production et la commercialisation des produits nanopharmaceutiques.
Objectif
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.
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IA - Innovation actionCoordinateur
4362 Esch Sur Alzette
Luxembourg