Although many novel nano-pharmaceuticals (NPs) which provide effective and safer therapies and diagnostic procedures for a wide range of diseases are being developed, the challenges to produce them in sufficient quantity and GMP quality required for late pre-clinical and clinical testing has resulted to declined number of new drugs brought onto market. To allow successful implementation of NPs, 12 Partners collaborated in order to establish science- and regulatory-based Open Innovation Test Bed (OITB). PHOENIX-OITB aims to enable the seamless, timely and cost-friendly transfer of NPs from lab bench to clinical trials by providing the necessary advanced, affordable and easily accessible expertise. It will offer a single-entry point for a consolidated network of facilities, technologies, services and expertise for all the technology transfer aspects from characterization, advanced testing, verification up to scale-up, GMP compliant manufacturing and regulatory guidance, provide business proposals, negotiate contracts, and address legal and technical issues.
Learning Objectives:
understanding the challenges to produce GMP quality novel nano-pharmaceuticals
overview the advantage of modular departmental structures of an OITB which are independent but collaborating closely for execution of demo-cases and end-users’ projects.
overview “one-stop shop” service approach of PHOENIX-OITB through a single entry point concept
