Pharmaceutical Open Innovation Test Bed for Enabling Nano-pharmaceutical Innovative Products

Project Information

Phoenix

Grant agreement ID: 953110

DOI

10.3030/953110

Project closed

EC signature date 16 December 2020

Start date 1 March 2021

End date 31 August 2025

Funded under

• INDUSTRIAL LEADERSHIP - Leadership in enabling and industrial technologies – Nanotechnologies

Total cost

€ 14 426 806,10

EU contribution

€ 11 102 823,04

Coordinated by

LUXEMBOURG INSTITUTE OF SCIENCE AND TECHNOLOGY
Luxembourg

Periodic Reporting for period 3 - Phoenix (Pharmaceutical Open Innovation Test Bed for Enabling Nano-pharmaceutical Innovative Products)

Reporting period: 2024-03-01 to 2025-08-31

Summary of the context and overall objectives of the project

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.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

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.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

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.

Phoenix project logo