Transfer nano-pharmaceuticals from lab bench to clinical trials
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 offers a Single Entry Point for 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 has the following specific objectives to reach such aim:
Creation of a “single-entry point” (SEP) for nano-pharmaceuticals: This objective is addressed by integrating existing knowledge, best practices and expertise from relevant previous and on-going national, EU and international activities. The services provided by the OITB will be based on open access at fair conditions and cost, and are meant for users encompassing pharmaceutical quality management system (PQMS), methodological portfolio, characterisation, testing and production facilities, as well as, communication strategy.
Finding solutions for the important hurdle in the translational process of most nano-pharmaceuticals - the so-called “innovation valley of death” situation due to lack/deficit of know-how, testing method, technology or facility prior to clinics - by guiding and execution of technology transfer to overcome scale-up and GMP production bottlenecks by implementing a “fast-track-to-GMP” strategy where intensive characterisation of the product dictates the main requirements of the scale-up and production.
One-stop shopping for GMP: The PHOENIX consortium provides the OITB all the necessary infrastructure and services for seamless transfer of nano-pharmaceuticals from lab scale to GMP production. This will not be limited only to scaling up and production but also encompassing all relevant aspects of cGMP to create fully certified and GMP quality products which can be directly tested in late preclinical and clinical studies (as clinical test materials).
Establishment of a PQMS able to tackle regulatory, economic, organisational and technical aspects of risk/benefit (R/B) ratio assessment: This objective is addressed by following a multidisciplinary approach that includes partners from academia, medicine, governmental bodies, industry and SMEs, as well as close collaboration with existing and forthcoming regulatory frameworks.
Launching PHOENIX Quality-by-Design (QbD), Safe-by-Design (SbD) and Sustainability-by-Design (Sus-b-D) concepts matching the pharmaceutical industry needs and performing all testing procedures in a standardised way to guarantee earliest possible risk/benefit (R/B) ratio assessment for nano-pharmaceuticals: These three concepts describe, from a holistic perspective, a strategy to quantify the potential environmental, human health, economic and societal risks and impact, as well as potential benefits, of different nano-pharmaceutical products.
Assessment and demonstration of PHOENIX applicability in relevant industrial environments by means of five demo-cases (initial TRL≥4): This assessment also serves as guidance and quantitative measure of progress and indicator of achievements for the project objectives.
Achieving PHOENIX financial sustainability: This objective is addressed by business development, dissemination and exploitation activities that will allow PHOENIX-OITB reaching a large number of end-users and stakeholders globally after the end of its funding period. The planned activities include different workshops and open days, as well as establishment of a business development department. The PHOENIX-OITB aims to generate sufficient turnover in order to ensure long term financial sustainability.