Project Summary

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 successfully transfer 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 the 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 a 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 characterisation, 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, start-ups 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 characterisation under GMP conditions, safety evaluation, regulatory compliance and commercialisation boost.