If handled incorrectly, medicines based on proteins are easily broken down, risking their safety and efficacy. New IMI project RealHOPE aims to address the issue.
Many new medicines are based on proteins, and these have dramatically improved the lives of people with a range of diseases. However, ensuring the quality of protein drug products, particularly after manufacture, is far from easy. Proteins can be affected by exposure to heat, sunlight or shaking. If stored or handled inappropriately during transport, or at the hospital, pharmacy or patient’s home, the proteins can break down, compromising the safety and efficacy of the product.
Now a new IMI project, dubbed RealHOPE, aims to deliver knowledge and tools to address this issue.
One major project goal is to improve our understanding of how protein drugs are handled in the real world, and the effect this has on product quality. To do this, the project will use smart tag technologies to log light, temperature and shock during real-life protein handling. They will also analyse the proteins at different stages. The data gathered will be used to identify the level and type of protein degradation triggered by different aspects of handling. The project team will also interview people who work in pharmacies and clinics as well as patients and carers to understand how they currently handle protein drugs and what limitations they face.
The project will use the data from these studies to develop teaching materials, including apps, for different target groups, namely hospital pharmacists, nurses, patients, and care givers.
Ultimately, RealHOPE will aid in the development of more robust, safer protein drugs.
RealHOPE has a budget of EUR 7 million, with around EUR 3 million coming from IMI and around EUR 4 million coming from the large pharmaceutical companies in the project. It will run until June 2025.