Product Deﬁnition Technology Develop- ment Quality Manage- ment Risk & Safety Assessment Regulatory Support Upscaling Sustain- ability Training Marketing Product Develop- ment PHOENIX project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 953110. OUR TEAM The PHOENIX team consists of 12 international partners distributed across 6 coun- tries. The partners are from the following countries: Austria, Croatia, Germany, Lux- embourg, Netherlands and Spain. All partners contribute actively to the project to establish the service portfolio of PHOENIX to cover the whole supply chain leading to GMP manufacturing of nanopharmaceuticals. 4 PHOENIX-OITB SERVICE PORTFOLIO The PHOENIX-OITB service portfolio is divided into 5 different categories. Each category includes a list of services, all of which together cover the different topics needed for the development of nano-pharmaceuticals from early stage to entry into clinical trials. 1 HOW IT WORKS PHOENIX concept & service strategies PHOENIX offers solutions to overcome the biggest hurdle in the translation process of most nano-pharmaceuticals – the so-called “innovation valley of death”. To learn more visit: www.phoenix-oitb.eu GET IN TOUCH info@phoenix-oitb.eu PHOENIX-OITB – A single entry point to develop and upgrade innovative nanopharmaceuticals The Single Entry Point of the PHOENIX-OITB provides access to a consolidated net- work of facilities, technologies, services and expertise for all technology trans- fer aspects from characterization, testing, verification up to scale up, GMP compliant manufacturing and regulatory guidance. The OITB services include production and characterisation under GMP con- ditions, safety evaluation, regula- tory compliance and commercia- lisation boost. METHODS The PHOENIX-OITB has been structurally conceived, designed and officially registered under the legal non-profit company, PHOENIX gGmbH. To test the operative capacity of PHOENIX-OITB, five demo-cases of different NP types, manufacturing methods and administration routes will be employed. Additionally, two pro bono demo-cases will be launched and granted to external users to test the services at relevant and operational environment. ABSTRACT The PHOENIX Open Innovation Test Bed (PHOENIX-OITB) is focused on overcoming the challenges of production of novel and innovative nanopharmaceuticals (NPs) from lab scale to GMP quality and production, maximising bioavailability, stability and manufacturing to allow their implementation in the medicine field. PHOENIX-OITB is a non-profit, open and self-sustaining legal entity that works as a Single-Entry-Point (SEP) providing its end-users transparent processes and proce- dures as well as easy access to services and expertise needed to bridge the gap bet- ween the bench and the bedside, i.e., providing them with high-quality services, capable of Quality-Efficacy and Safety (QES) evaluation and production of nanophar- maceuticals at large scales, meeting the regulatory and GMP requirements. RESULTS Process transfer and method development for all five demo-cases are ongoing while GMP production area is being constructed. The Pharmaceutical Quality Management System (PQMS) is being established and all exploitation activities are being managed and can be seen through: www.phoenix-oitb.eu. Furthermore, PHOENIX-OITB Open Call for the granting of two pro bono demo-cases to external end-users has been launched and applications are under evaluation. Johanna K. Scheper,1,12,* Alba Cordoba,2 Ariadna Padrós,3 Nora Ventosa,4 Jesus M. De la Fuente,4 Ivana Vinković Vrček,5 Hannes Bauer,6 Mangala Srinivas,7 Sabine Fleischer,8 Robert Holzer,9 Tommaso Serchi,10 Nazende Günday-Türeli11 1 BioNanoNet Forschungsgesellschaft mbH, Graz, Austria, 2 Nanomol Technologies S.L, Barcelona, Spain, 3 Leanbio S.L, Barcelona, Spain, 4 Consejo Superior de Investigaciones Cientificas (CSIC), Spain, 5 Ins- titute for Medical R