Periodic Reporting for period 1 - Phoenix (Pharmaceutical Open Innovation Test Bed for Enabling Nano-pharmaceutical Innovative Products)
Reporting period: 2021-03-01 to 2022-08-31
The establishment of current good manufacturing practice (cGMP) in nano-pharmaceutical production at large scale represents the first prerequisite to transfer successfully the nano-pharmaceuticals from bench to bedside (from lab scale to industrial scale). 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 the main prerequisites for successful implementation of these advances to further enhance the growth and innovation capacity. To allow successful implementation of the nano-pharmaceuticals in the medicine 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 single entry point (SEP) for 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. The Phoenix-OITB is customised for enabling SMEs and all interested end-users for development and production of GMP quality nano-pharmaceutical products for advanced preclinical and clinical studies.
Phoenix has the following specific objectives to reach such aim:
- Creation of a SEP for services all around nano-pharmaceuticals which 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 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.
- Offering one-stop shopping for GMP owing to the necessary infrastructure and services for seamless transfer of nano-pharmaceuticals from lab scale to GMP production being under one roof.
- Establishment of a PQMS able to tackle regulatory, economic, organisational and technical aspects of risk/benefit ratio assessment.
- 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 standardized way.
- Assessment and demonstration of Phoenix applicability in relevant industrial environments by means of five demo-cases as guidance and quantitative measure of progress and indicator of achievements for the project objectives.
- Achieving Phoenix financial sustainability by business development, dissemination and exploitation activities that will allow Phoenix-OITB reaching a large number of end-users and stakeholders globally after end of funding period.
By this way, Phoenix-OITB will facilitate penetration and acceptance of new and breakthrough key enabling technologies (KETs) into the market by offering them guidance and support for compliance with cGMP and providing an insight for integration of such KETs in the existing supply chains. Thus, Phoenix-OITB aims to contribute to boosting competitiveness, jobs creation and supporting growth in Europe. Phoenix`s goal is the creation of a successful Phoenix-OITB that will reinforce Europe's industrial leadership in nanomedicine and healthcare sector globally and strengthen European industry's ability to continuously adapt and innovate by embracing new technologies, the transition to greener technology and more circular economy.
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 single entry point (SEP) for 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. The Phoenix-OITB is customised for enabling SMEs and all interested end-users for development and production of GMP quality nano-pharmaceutical products for advanced preclinical and clinical studies.
Phoenix has the following specific objectives to reach such aim:
- Creation of a SEP for services all around nano-pharmaceuticals which 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 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.
- Offering one-stop shopping for GMP owing to the necessary infrastructure and services for seamless transfer of nano-pharmaceuticals from lab scale to GMP production being under one roof.
- Establishment of a PQMS able to tackle regulatory, economic, organisational and technical aspects of risk/benefit ratio assessment.
- 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 standardized way.
- Assessment and demonstration of Phoenix applicability in relevant industrial environments by means of five demo-cases as guidance and quantitative measure of progress and indicator of achievements for the project objectives.
- Achieving Phoenix financial sustainability by business development, dissemination and exploitation activities that will allow Phoenix-OITB reaching a large number of end-users and stakeholders globally after end of funding period.
By this way, Phoenix-OITB will facilitate penetration and acceptance of new and breakthrough key enabling technologies (KETs) into the market by offering them guidance and support for compliance with cGMP and providing an insight for integration of such KETs in the existing supply chains. Thus, Phoenix-OITB aims to contribute to boosting competitiveness, jobs creation and supporting growth in Europe. Phoenix`s goal is the creation of a successful Phoenix-OITB that will reinforce Europe's industrial leadership in nanomedicine and healthcare sector globally and strengthen European industry's ability to continuously adapt and innovate by embracing new technologies, the transition to greener technology and more circular economy.
The project addresses establishment of a sustainable OITB to cover all the aspects of GMP production from development and technology transfer through scale-up to regulatory guidance.
Within the Phoenix project, the partners’ facilities will be upgraded and GMP certified, if not already available, to enable full operability of the pilot plant. The Phoenix consortium will serve as a “single-entry point” SEP to the constellation of all services and technologies around nano-pharmaceuticals, technologies and infrastructure already established by the project partners. The SEP structure saves time for end-users by providing efficient answers and solutions to their needs and demands. Users will be guided from a SEP towards “modular structures” suited to their needs. When an interested party contacts the Phoenix-OITB, technology transfer experts will analyse the specific request together with the project managers and offer the appropriate methods/technologies to answer the customer’s needs.
Preparatory work for exploitation of project results along the whole value-chain as Phoenix OITB services was performed during the project proposal phase. The business plan for the Phoenix OITB will be addressed more in detail as the project progresses and demo cases advance.
Besides general communication activities, Phoenix project is present in Social Media (Twitter and LinkedIn).
The project is already showcased at relevant scientific conferences and networking events. The Phoenix consortium was represented in the recent OITB workshop where first and second generation OITBs funded by EC and stakeholders were among the audience.
Within the Phoenix project, the partners’ facilities will be upgraded and GMP certified, if not already available, to enable full operability of the pilot plant. The Phoenix consortium will serve as a “single-entry point” SEP to the constellation of all services and technologies around nano-pharmaceuticals, technologies and infrastructure already established by the project partners. The SEP structure saves time for end-users by providing efficient answers and solutions to their needs and demands. Users will be guided from a SEP towards “modular structures” suited to their needs. When an interested party contacts the Phoenix-OITB, technology transfer experts will analyse the specific request together with the project managers and offer the appropriate methods/technologies to answer the customer’s needs.
Preparatory work for exploitation of project results along the whole value-chain as Phoenix OITB services was performed during the project proposal phase. The business plan for the Phoenix OITB will be addressed more in detail as the project progresses and demo cases advance.
Besides general communication activities, Phoenix project is present in Social Media (Twitter and LinkedIn).
The project is already showcased at relevant scientific conferences and networking events. The Phoenix consortium was represented in the recent OITB workshop where first and second generation OITBs funded by EC and stakeholders were among the audience.
The Phoenix project responds to the current and future needs and challenges in bringing the newly developed nano-pharmaceuticals from the bench to the bed side enabling fast development of nano-pharmaceuticals and efficient scaling up of the production methods. This will be achieved by creating a SEP OITB where all aspects of a transition from a lab scale to a fully GMP quality product are covered. The Phoenix will deliver the OITB structure to i) enable a smooth transfer from lab scale to GMP grade product covering all necessary QES, regulatory, and upscaling aspects, ii) encourage researchers to keep developing innovative nano-pharmaceuticals for medical therapies and diagnostic procedures guiding them for successful clinical translation, iii) shorten the time to clinical trials and lower the failure risk during the scale-up. Moreover, Phoenix-OITB will ensure that the different researchers from the nanomedicine community and in the pharma-industry significantly increase their capacity to influence the development process for their innovative products, thus becoming catalyst for the change in the current status of nano-pharmaceuticals bringing the products one step closer to the market. This novel created eco-system in the field will foster a thriving economy enabling the community to build successful and creative enterprises from which Europe will benefit economically, creatively, maintaining safety and confidence with the medical and patient communities, while supporting those SMEs to bring clinical evidence to their products. Phoenix consortium shares the same passion and engagement as the nano-pharmaceutical researchers in strongly contributing to improve patients live and contribute to societal prosperity.