Europe faces significant healthcare challenges due to an aging population and the rise in chronic diseases. Nanotherapies, such as lipid and metal oxide nanoparticles, offer advanced therapeutic solutions for cancer, vaccines, and gene therapies, but require extremely stringent safety and quality standards for clinical application.
This project directly addresses the need for standardization expressed by industry and regulatory agencies such as the EMA. The central objective is to develop and validate traceable measurement methods and new candidates for reference materials (RMs) useful for assessing the critical quality attributes of nanopharmaceuticals.
The research focuses on advanced chemical and physical characterization. The aim is to precisely measure the dimensions of nanoparticles smaller than 10 nanometers, their structural integrity, lipid composition, and surface properties. Another key aspect involves studying the stability of these particles within complex biological matrices, optimizing isolation techniques to minimize external interference.
The project will also develop tissue phantom models to accurately track cellular uptake and distribution. The results will support the clinical approval of safer and more effective therapies, promoting new international regulatory standards and strengthening Europe's technological leadership in the medical sector.
Contributing scientific sectors
