Periodic Reporting for period 3 - Phoenix (Pharmaceutical Open Innovation Test Bed for Enabling Nano-pharmaceutical Innovative Products)
Okres sprawozdawczy: 2024-03-01 do 2025-08-31
The translation of nano-pharmaceuticals from laboratory research to clinical application requires full compliance with current Good Manufacturing Practice (cGMP) standards. Although nano-pharmaceuticals offer significant clinical, technological, and socio-economic benefits, their successful market uptake has been hindered by the lack of affordable, advanced, and accessible GMP-compliant testing and manufacturing facilities.
PHOENIX addressed this challenge by establishing a science- and regulation-based Open Innovation Test Bed (OITB) that enables a seamless, timely, and cost-efficient transfer of nano-pharmaceuticals from bench to bedside. Central to this achievement was the creation of a Single Entry Point (SEP) integrating advanced infrastructure, technologies, services, and regulatory expertise. Through this platform, SMEs, academic developers, and industry gain open and fair access to the complete nano-pharmaceutical development chain, including design, process development, characterization, testing, scale-up, GMP-compliant manufacturing, and regulatory guidance.
The specific objectives of PHOENIX were to:
• Create an open-access SEP for nano-pharmaceutical services under fair conditions.
• Establish a Pharmaceutical Quality Management System (PQMS) integrating regulatory, technical, and economic risk–benefit assessment.
• Implement a fast-track-to-GMP strategy based on intensive characterization.
• Provide a one-stop-shop environment for GMP manufacturing.
• Deploy Quality-by-Design (QbD), Safe-by-Design (SbD), and Sustainability-by-Design (Sus-b-D) concepts tailored to nano-pharmaceuticals.
• Demonstrate the OITB model through industrial demo-cases.
• Develop a sustainable business model ensuring long-term operation beyond project funding.
PHOENIX fully achieved its objectives. The PHOENIX-OITB gGmbH was established in November 2023 and is fully operational, coordinating upgraded and GMP-certified partner facilities under a unified SEP. Six partners joined as shareholders, ensuring financial sustainability. The OITB employs dedicated staff, operates under a fully implemented PQMS, and provides a transparent and structured service portfolio. Five industrial demo-cases and two pro-bono cases successfully demonstrated the technical and regulatory viability of the PHOENIX OITB, confirming its capability to support late pre-clinical and early clinical development across multiple nano-pharmaceutical platforms.
PHOENIX addressed this challenge by establishing a science- and regulation-based Open Innovation Test Bed (OITB) that enables a seamless, timely, and cost-efficient transfer of nano-pharmaceuticals from bench to bedside. Central to this achievement was the creation of a Single Entry Point (SEP) integrating advanced infrastructure, technologies, services, and regulatory expertise. Through this platform, SMEs, academic developers, and industry gain open and fair access to the complete nano-pharmaceutical development chain, including design, process development, characterization, testing, scale-up, GMP-compliant manufacturing, and regulatory guidance.
The specific objectives of PHOENIX were to:
• Create an open-access SEP for nano-pharmaceutical services under fair conditions.
• Establish a Pharmaceutical Quality Management System (PQMS) integrating regulatory, technical, and economic risk–benefit assessment.
• Implement a fast-track-to-GMP strategy based on intensive characterization.
• Provide a one-stop-shop environment for GMP manufacturing.
• Deploy Quality-by-Design (QbD), Safe-by-Design (SbD), and Sustainability-by-Design (Sus-b-D) concepts tailored to nano-pharmaceuticals.
• Demonstrate the OITB model through industrial demo-cases.
• Develop a sustainable business model ensuring long-term operation beyond project funding.
PHOENIX fully achieved its objectives. The PHOENIX-OITB gGmbH was established in November 2023 and is fully operational, coordinating upgraded and GMP-certified partner facilities under a unified SEP. Six partners joined as shareholders, ensuring financial sustainability. The OITB employs dedicated staff, operates under a fully implemented PQMS, and provides a transparent and structured service portfolio. Five industrial demo-cases and two pro-bono cases successfully demonstrated the technical and regulatory viability of the PHOENIX OITB, confirming its capability to support late pre-clinical and early clinical development across multiple nano-pharmaceutical platforms.
During the project, PHOENIX established a fully operational and sustainable OITB integrating infrastructure, services, and expertise covering the entire GMP-compliant nano-pharmaceutical development chain.
Key achievements include:
1. Operationalization of the SEP
• Establishment of the PHOENIX OITB gGmbH with dedicated staff and a centralized governance structure providing tailored service coordination.
2. Infrastructure upgrade and certification
• Upgrading partner facilities toward GMP, GLP, and GIVIMP standards.
• MyB obtained GMP manufacturing authorization in 2024 for human medicinal products and investigational medicinal products.
• In vitro and in vivo laboratories progressed toward GLP and GIVIMP authorization.
3. Comprehensive service portfolio
• Development of a Quality, Efficacy, and Safety (QES) portfolio comprising more than 290 services across six categories.
• Integration of QbD, SbD, and Sus-b-D principles into workflows and training.
4. Demonstration activities
• Execution of five industrial demo-cases and two pro-bono cases, providing GMP-like manufacturing, validated analytical methods, in silico modelling, pre-clinical testing, and PQMS-aligned workflows.
• Advancement of technologies from TRL 4–5 to TRL 6.
5. PQMS implementation
• Establishment of SOPs, validation master plans, supplier qualification, personnel training, and internal audits.
6. In silico modelling and data management
• Development of scalable modelling tools and structured, regulatory-compliant data generation.
7. Dissemination and stakeholder engagement
• Broad dissemination through conferences, workshops, training events, and European Commission OITB activities.
8. Business model and exploitation
• Development of a robust business plan ensuring post-project sustainability and continued operation of the SEP as a European hub.
Key achievements include:
1. Operationalization of the SEP
• Establishment of the PHOENIX OITB gGmbH with dedicated staff and a centralized governance structure providing tailored service coordination.
2. Infrastructure upgrade and certification
• Upgrading partner facilities toward GMP, GLP, and GIVIMP standards.
• MyB obtained GMP manufacturing authorization in 2024 for human medicinal products and investigational medicinal products.
• In vitro and in vivo laboratories progressed toward GLP and GIVIMP authorization.
3. Comprehensive service portfolio
• Development of a Quality, Efficacy, and Safety (QES) portfolio comprising more than 290 services across six categories.
• Integration of QbD, SbD, and Sus-b-D principles into workflows and training.
4. Demonstration activities
• Execution of five industrial demo-cases and two pro-bono cases, providing GMP-like manufacturing, validated analytical methods, in silico modelling, pre-clinical testing, and PQMS-aligned workflows.
• Advancement of technologies from TRL 4–5 to TRL 6.
5. PQMS implementation
• Establishment of SOPs, validation master plans, supplier qualification, personnel training, and internal audits.
6. In silico modelling and data management
• Development of scalable modelling tools and structured, regulatory-compliant data generation.
7. Dissemination and stakeholder engagement
• Broad dissemination through conferences, workshops, training events, and European Commission OITB activities.
8. Business model and exploitation
• Development of a robust business plan ensuring post-project sustainability and continued operation of the SEP as a European hub.
PHOENIX represents a major advance beyond the state of the art by establishing Europe’s first fully integrated OITB dedicated to nano-pharmaceuticals. The OITB combines technical, regulatory, quality, and manufacturing capabilities within a single harmonized framework, enabling efficient transition from lab-scale research to GMP-grade products.
Key impacts include:
1. Scientific and technological impact
• Demonstration of scalable GMP-like production for multiple nano-pharmaceutical platforms.
• Systematic implementation of QbD, SbD, and Sus-b-D methodologies.
• Establishment of GLP/GIVIMP-aligned safety and efficacy testing workflows.
2. Economic and industrial impact
• Strengthened EU competitiveness in nanomedicine.
• Reduced development timelines and scale-up failure risks for SMEs and innovators.
• Improved access to high-quality GMP infrastructure.
3. Regulatory and societal impact
• Enhanced regulatory alignment through PQMS implementation.
• Increased safety, transparency, and trust in nano-pharmaceutical development.
4. Environmental impact
• Adoption of energy-efficient technologies and predictive in silico tools.
• Reduced material consumption and waste.
• Alignment with circular-economy and sustainability principles.
In conclusion, PHOENIX has fully met and exceeded its objectives by creating a sustainable, operational OITB that bridges the gap between nano-pharmaceutical research and clinical application. Through its open-access SEP, validated methodologies, and integrated service portfolio, PHOENIX establishes a long-term European ecosystem supporting academia, SMEs, and industry in accelerating safe, efficient, and GMP-compliant nano-pharmaceutical innovation.
Key impacts include:
1. Scientific and technological impact
• Demonstration of scalable GMP-like production for multiple nano-pharmaceutical platforms.
• Systematic implementation of QbD, SbD, and Sus-b-D methodologies.
• Establishment of GLP/GIVIMP-aligned safety and efficacy testing workflows.
2. Economic and industrial impact
• Strengthened EU competitiveness in nanomedicine.
• Reduced development timelines and scale-up failure risks for SMEs and innovators.
• Improved access to high-quality GMP infrastructure.
3. Regulatory and societal impact
• Enhanced regulatory alignment through PQMS implementation.
• Increased safety, transparency, and trust in nano-pharmaceutical development.
4. Environmental impact
• Adoption of energy-efficient technologies and predictive in silico tools.
• Reduced material consumption and waste.
• Alignment with circular-economy and sustainability principles.
In conclusion, PHOENIX has fully met and exceeded its objectives by creating a sustainable, operational OITB that bridges the gap between nano-pharmaceutical research and clinical application. Through its open-access SEP, validated methodologies, and integrated service portfolio, PHOENIX establishes a long-term European ecosystem supporting academia, SMEs, and industry in accelerating safe, efficient, and GMP-compliant nano-pharmaceutical innovation.