Quality requirements

Leading scientific and regulatory bodies in the pharmaceutical field acknowledged that the lack of established methods to provide reliable preclinical data represents the bottleneck in bringing promising nanomedicines to the market. The aim of this project is to perform a thorough analysis of selected pharmaceutical nanosystems, focusing on the determination of size, shape, surface properties, and bio-nano interaction assessment (as selected combination of critical quality attributes - CQAs), applying a combination of orthogonal and complementary techniques. The overall impact of this project will lead to the reduction of risks, time, and financial investment in preclinical development of nanomedicines and "nanosimilars", by suggesting new methods and optimized protocols for physicochemical and _in vitro_ quality and safety assessment of these complex, innovative products. The project activities will gather information obtained from selected state-of-the-art methodologies, pointing out the minimal information level required for reliable nanomedicine characterization, bringing nanomedicines to a "more mature phase".