The development of nanotechnology-based medicines and vaccines relies on modern interdisciplinary approaches that integrate physical chemistry, biology, materials engineering, and more recently, Artificial Intelligence. A central role in these approaches is played by the self-organization of nanosystems, through which lipidic and polymeric nanostructures assemble into ordered architectures with controlled morphology and functionality. The liquid crystalline state enables the formation of lipid domains (lipid rafts), which significantly influence the functionality of nanocarriers such as liposomes and lipid nanoparticles. Artificial lipid raft-like domains within nanosystems exhibit behaviors that resemble those of biological membranes, whose structure and function serve as a fundamental model for the rational design of innovative drug delivery systems and next-generation vaccines.

The seminar will present and discuss key concepts including self-organization, complexity, liquid crystalline behavior, and thermodynamics of nanoscale drug delivery systems. In addition, currently marketed nanotherapeutic products and vaccines will be presented, illustrating the translation of nanoscience into clinical and commercial applications.

Finally, the seminar will address the challenges posed by the regulatory frameworks of international drug and vaccine approval authorities, with a focus on the need for robust scientific evidence to capture the complexity of nanotechnology-based medicinal products. This is critical both for the development of innovative originator drugs and for the production of their “similar” counterparts.