RealHOPE: Handling of protein drugs

Protein drugs have grown in use over the past 20 years and have revolutionized the treatment of many diseases, but their complex structure makes them much more sensitive than traditional drugs. They can be adversely affected by heat, light, shaking or contact with packaging materials, for example. Even small mistakes in the way the medicine is handled can degrade its quality and cause the treatment to fail. This can lead to poorer patient outcomes and more expensive care.

Studies in real-life settings

Despite extensive knowledge about manufacturing and distribution, few previous studies have examined what happens to these medicines after they leave the factory. The RealHOPE research project addressed this gap in knowledge by studying the journey of medicines to hospitals, pharmacies and patients - in real-life settings. The project involved a wide range of stakeholders - pharmaceutical companies, transport companies, pharmacies and a patient association. It also involved experts in technology, apps and research to better understand the whole journey of a protein drug, from production to reaching the patient. The project provided important new insights into how medicines are managed in everyday life. This knowledge can help develop better practices, safer technologies and new medicines that better meet the challenges of the real world.

Five different work packages

RealHOPE was organized in five work packages with different perspectives. One analyzed how protein drugs are handled in practice, one developed simulation tools to show how handling situations affect the stability of the drugs, one focused on technical solutions and safer practices in hospital pharmacies, and one developed educational materials to increase the knowledge of healthcare professionals and patients.

RealHOPE has collected data on the real-life handling of protein medicines through:

• Field measurements using smart sensor technologies that log light, temperature and shock during transportation and handling.
• Analyzing the quality of medicines at different stages, to understand how these factors affect stability.
• Interviews with healthcare professionals and patients to get an overall picture of handling practices and training needs.

Based on this, RealHOPE has:

• Developed tools and methods to simulate real-life handling scenarios, so that future medicines can be designed to be more robust.
• Developed practical recommendations and training materials for healthcare professionals, pharmacies and patients.
• Helped translate research findings into regulations and guidelines, allowing future protein medicines to be approved in a better and safer way.

RealHOPE research studies

During the project, extensive research studies were conducted. The results are an important basis for the development of future medicines and guidelines to improve patient safety.

Project results

Educational material

One of the RealHOPE work packages focused on the development of training materials that help to increase knowledge on the proper handling of protein drugs. Below you will find educational materials for different target groups:

More about RealHOPE

The project brought together 24 stakeholders from six European countries and the United States - including pharmaceutical companies, universities, institutes, hospital pharmacies, logistics and technology companies, and a patient organization. The project was coordinated by RISE Research Institutes of Sweden and Lund University, with Sanofi as technical lead.