Periodic Reporting for period 4 - RealHOPE (Real World Handling of Protein Drugs - Exploration, Evaluation and Education)
Período documentado: 2024-07-01 hasta 2025-06-30
What is the problem being addressed?
Innovative protein-based medicines have become much more common in recent years and have made a big difference for people with serious health conditions. But they are sensitive and require careful handling to preserve the activity. During production and delivery to pharmacies optimal conditions, such as temperature, are ensured and carefully monitored. However, research on transportation and further handling in real life are minimal. Despite their growing use in hospitals and at home, the understanding of how real-life handling affects these medicines has been limited.
Why is it important for society?
Biologic drugs are essential treatments for many chronic and serious conditions, including cancer, autoimmune diseases, and diabetes. It is well known that proteins may be affected by exposure to heat, sunlight or shaking, however, it is not known to what extent transportation and handling can cause an adverse effect on these specific types of drugs. Ensuring their stability and effectiveness of protein-based medicines is critical for patient safety and healthcare efficiency. For example, not knowing how drugs react to shaky transportation or being left on a sunny garden table by patients might lead to fully functional drugs being discarded or drugs that lack in efficiency being administered to the patient.
What are the overall objectives and conclusions of the project?
The RealHOPE project aimed to improve the understanding and management of protein drug handling in real-world settings. Over four years, the project brought together researchers, hospitals, patient organizations, and pharmaceutical companies to investigate how these drugs are handled in everyday life and to develop tools, guidelines, and educational materials to improve practices.
The main objective has been:
• Understanding Real-Life Handling
• Simulating Real-Life Stress Conditions that mimic stress events during real-life
• Improve safety in hospital pharmacies
• Developing Educational Materials for healthcare providers and patients
• Influencing Guidelines and Policy for safer handling practices
Innovative protein-based medicines have become much more common in recent years and have made a big difference for people with serious health conditions. But they are sensitive and require careful handling to preserve the activity. During production and delivery to pharmacies optimal conditions, such as temperature, are ensured and carefully monitored. However, research on transportation and further handling in real life are minimal. Despite their growing use in hospitals and at home, the understanding of how real-life handling affects these medicines has been limited.
Why is it important for society?
Biologic drugs are essential treatments for many chronic and serious conditions, including cancer, autoimmune diseases, and diabetes. It is well known that proteins may be affected by exposure to heat, sunlight or shaking, however, it is not known to what extent transportation and handling can cause an adverse effect on these specific types of drugs. Ensuring their stability and effectiveness of protein-based medicines is critical for patient safety and healthcare efficiency. For example, not knowing how drugs react to shaky transportation or being left on a sunny garden table by patients might lead to fully functional drugs being discarded or drugs that lack in efficiency being administered to the patient.
What are the overall objectives and conclusions of the project?
The RealHOPE project aimed to improve the understanding and management of protein drug handling in real-world settings. Over four years, the project brought together researchers, hospitals, patient organizations, and pharmaceutical companies to investigate how these drugs are handled in everyday life and to develop tools, guidelines, and educational materials to improve practices.
The main objective has been:
• Understanding Real-Life Handling
• Simulating Real-Life Stress Conditions that mimic stress events during real-life
• Improve safety in hospital pharmacies
• Developing Educational Materials for healthcare providers and patients
• Influencing Guidelines and Policy for safer handling practices
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.
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.
The RealHOPE project has delivered a wide range of insights that extend well beyond the current state of the art in the handling of protein-based drug products.
From a scientific and technological perspective, RealHOPE has introduced tools, such as smart label technology capable of tracking stressors, and methodologies that change how handling of protein-based medicines is understood. The resulting data has informed design of simulation protocols that replicate real-life scenarios and the creation of a device that allows for early-stage stress testing.
Clinically, RealHOPE has had a direct impact on hospital workflows. The project has identified critical risks and workflow variations that led to a list of best practices, which are now being disseminated to hospital pharmacists. The project also mapped educational needs and developed training materials for healthcare professionals and patients, ensuring that knowledge is transferred effectively and sustainably.
On the regulatory front, RealHOPE has initiated dialogue with European Medicines Agency (EMA) and national agencies to advocate for the inclusion of real-life stress testing in official stability guidelines.
Socio-economically, the project contributes to more efficient healthcare systems with better handling practices and more consistent dosing, which is particularly important for high-cost biologics. By involving patient organizations and developing tailored educational resources, the project empowers patients to manage their treatments safely and confidently. RealHOPE also facilitates collaboration between academia, industry, healthcare providers, and patients, creating a model for co-creation and inclusive innovation in pharmaceutical development.
In summary, RealHOPE has laid the foundation for a more resilient, informed, and patient-focused approach to biologic drug handling.
From a scientific and technological perspective, RealHOPE has introduced tools, such as smart label technology capable of tracking stressors, and methodologies that change how handling of protein-based medicines is understood. The resulting data has informed design of simulation protocols that replicate real-life scenarios and the creation of a device that allows for early-stage stress testing.
Clinically, RealHOPE has had a direct impact on hospital workflows. The project has identified critical risks and workflow variations that led to a list of best practices, which are now being disseminated to hospital pharmacists. The project also mapped educational needs and developed training materials for healthcare professionals and patients, ensuring that knowledge is transferred effectively and sustainably.
On the regulatory front, RealHOPE has initiated dialogue with European Medicines Agency (EMA) and national agencies to advocate for the inclusion of real-life stress testing in official stability guidelines.
Socio-economically, the project contributes to more efficient healthcare systems with better handling practices and more consistent dosing, which is particularly important for high-cost biologics. By involving patient organizations and developing tailored educational resources, the project empowers patients to manage their treatments safely and confidently. RealHOPE also facilitates collaboration between academia, industry, healthcare providers, and patients, creating a model for co-creation and inclusive innovation in pharmaceutical development.
In summary, RealHOPE has laid the foundation for a more resilient, informed, and patient-focused approach to biologic drug handling.