Real’HOPE project

RealHOPE was a 4-year research project (2021–2025) funded by the Innovative Medicines Initiative (IMI2 JU) with support from the EU Horizon 2020 programme and EFPIA companies. The project aimed to capture and measure real-life events during the handling of protein drugs in order to develop experimental methods for simulating these events. The ultimate goal was to contribute to the development of more robust biologics and improve patient safety.
Within Work Package 3, hospital workflows in Uppsala and Barcelona were mapped to identify critical stress factors, risk scenarios and educational gaps. Robotic compounding protocols were validated across sites, confirming reproducibility for automated preparation of monoclonal antibodies. In parallel, novel in-line analytical technologies were tested in clinical settings, demonstrating the feasibility of real-time monitoring of particle formation and Y-site compatibility during infusion. Additional studies addressed pneumatic tube transport (PTS) of monoclonal antibodies, highlighting the impact of headspace and surfactants on subvisible particle formation. These findings were combined with structured risk assessments to inform guideline development.
The results show that verification of automated systems and rapid quality control tools, supported by collaboration with EFPIA industry partners, can contribute to harmonization of biologics handling in hospital pharmacies. Furthermore, mapping of training needs among pharmacists and nurses highlights the importance of targeted educational materials. Together, these activities provide a foundation for improved patient safety, efficient workflows and European best practice guidelines for biologics handling.