From its launch, the RealHOPE project has focused on improving the safety, stability, and usability of protein-based medicines by investigating how these drugs are handled in real-world settings. The project brought together hospitals, universities, institutes, patient organizations, logistics and pharmaceutical companies to address the objectives.
Key Achievements Across the Project:
1. Real-world Data Collection
RealHOPE conducted extensive studies with patients and healthcare professionals to identify how protein drugs are handled in daily life. Smart labels were developed to monitor environmental stressors like temperature, light, and movement during transport and use, and observational studies at hospitals were performed. A patient study involving 12 participants provided valuable insights into common handling challenges, such as travel and home storage. These findings informed the design of simulation protocols and educational materials.
2. Simulation Protocols
Laboratory methods were created to mimic the effects of real-world handling on drug stability. These included simulations of hospital workflows, patient use, and transport conditions. A miniaturized testing device was developed to assess drug stability using very small sample volumes—ideal for early-stage drug development. Studies also evaluated the impact of Closed System Transfer Devices (CSTDs), which are increasingly used in hospitals but may affect drug quality.
3. Evaluation of Technological Innovations in Hospital
Robotic systems for drug preparation were tested and validated across multiple hospitals, demonstrating safer and more consistent compounding of biologics. Real-time analytical tools were also evaluated for monitoring drug quality during preparation. These technologies aim to reduce human error and improve patient safety.
4. Educational modules
RealHOPE produced training resources for patients, nurses, pharmacists, and academic audiences. These include videos, brochures, and online courses, now available on platforms such as Canvas, such as Canvas, the websites of Societa Italiana di Framacia Clinica e Terapia (Sifact), the Swedish Rheumatism Association (SRA) and RISE Research Institutes of Sweden. The materials are designed to promote safe handling practices and empower stakeholders with practical knowledge.
5. Guidelines and recommendations
The project initiated dialogues with regulatory bodies like EMA and the Swedish Medical Products Agency to advocate for the inclusion of real-life stress testing in official guidelines. A white paper summarizing key findings is being prepared. RealHOPE also hosted a major international conference in May 2025, bringing together 80 delegates from industry, academia, healthcare, and patient organizations to discuss the future of protein drug handling.
Exploitation and Dissemination
• Exploitable Results: Five key innovations were identified for future use, including smart labels, simulation protocols, educational modules, a microfluidic testing device, and a hospital testbed model.
• Publications: Ten peer-reviewed articles have been published, with 15 more in preparation.
• Outreach: Results were shared at numerous conferences and through platforms like LinkedIn and the RealHOPE website. A collaboration with the international Stabilis platform will further expand global dissemination.
