Nanotechnology in Biomedical Engineering: Advances in Drug Delivery, Diagnostics, and Cancer Therapy in the United States

Abstract

In the United States, nanotechnology is a major area of current biomedical engineering research, influencing the way diseases are diagnosed, monitored, and treated. In the last 20 years, the U.S. federal funding for nanoscale materials such as liposomes, lipid nanoparticles (LNPs), polymeric nanoparticles, metallic and carbon-based nanostructures, and quantum dots has brought these materials from bench to bedside through the National Nanotechnology Initiative, the National Institutes of Health (NIH), and the National Cancer Institute's Alliance for Nanotechnology in Cancer. The review focuses on recent developments in three related areas: (1) drug delivery systems based on nanoparticles to enhance the solubility and targeting of bioactive molecules, as well as their pharmacokinetics; (2) diagnostics and biosensors based on nanomaterials that allow for the early and point-of-care detection of diseases; and (3) cancer therapy using nanotechnology, including nanocarriers for chemotherapy, nucleic acid therapeutics, and personalized vaccines based on nanoparticles. Special focus is given to the FDA approved nanomedicines, current clinical trials, and remaining regulatory and translational hurdles such as nanotoxicology, manufacturing scalability, and the lack of harmonized regulatory guidance, which still hinder clinical uptake. The review concludes with an outlook on new directions such as AI-assisted design of nanoparticles, multifunctional theranostic platforms, and mRNA-LNP cancer vaccines that are poised to shape the next ten years of nanomedicine in the United States.