Taking nanoparticle therapeutic and diagnostic platforms from the laboratory to the clinic requires a well-defined pre-clinical route for FDA approval that must include widely adopted and standardized procedures for assessing the efficacy and toxicity/health risk of new nanomaterials. Certified reference materials underpin the approval procedures and enable interlaboratory comparison and benchmarking. To this end, we are working to develop measurement protocols (assays), consensus standard test methods, and computational tools for the physicochemical characterization of different nanoparticle classes under physiologically and environmentally relevant conditions. Particle properties characterized include size and size distribution, surface area, surface charge, zeta potential, crystallinity, aggregation, stability, transport characteristics, chemical composition, purity, and photothermal/plasmonic behavior.
Impact and Customers:
- Annual healthcare costs associated with cancer treatment exceed $188 billion, yet the mortality rate for cancer in 2002 was identical to that in 1950. According to the National Cancer Institute (NCI), "nanotechnology will change the very foundations of cancer diagnosis, treatment, and prevention."
- NIST collaboration with NCI and the Food and Drug Administration (FDA) provides a framework for developing a standardized analytical cascade for physical and biological characterization of nanoparticles for imaging, diagnosis and therapy.
- New consensus standards for characterization of biomedical nanoparticles are currently under development within ASTM committee E56 on Nanotechnology.
- NIST interactions with NCI, FDA, the National Institute of Occupational Safety and Health (NIOSH), and the National Toxicology Program (NTP) have fostered robust interagency cooperation and enabled us to focus our resources on nanoparticle standards priorities for the biomedical and EHS sectors.