Descripción del proyecto
Una plataforma para proporcionar nanofármacos a los pacientes
Los avances en nanotecnología han encontrado aplicaciones en la industria farmacéutica, lo que tiene efectos positivos en los pacientes y la sociedad en general. Para seguir reforzando la capacidad de crecimiento y de innovación de la nanotecnología, se deben mejorar las instalaciones de fabricación y prueba. El proyecto Phoenix, financiado con fondos europeos, tiene como objetivo facilitar la traducción de los nanofármacos desde el laboratorio hasta el paciente mediante la creación de un banco de pruebas de innovación abierta (OITB, por sus siglas en inglés) que cumpla con las directrices normativas y las buenas prácticas de fabricación. Phoenix-OITB consistirá en una red de instalaciones, tecnologías, servicios y experiencia en transferencia de tecnología para acelerar la producción y comercialización de nanofármacos.
Objetivo
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.
Ámbito científico
Palabras clave
Programa(s)
Convocatoria de propuestas
Consulte otros proyectos de esta convocatoriaConvocatoria de subcontratación
H2020-NMBP-TO-IND-2020-twostage
Régimen de financiación
IA - Innovation actionCoordinador
4362 Esch Sur Alzette
Luxemburgo