The Nanotechnology Characterization Laboratory (NCL) has developed a standardized analytical assay cascade to assist nanotechnology-based drug and device developers with preclinical characterization aimed at defining nanoparticle physicochemical properties, immunological compatibility, general toxicity, and pharmacology. Such characterization is essential for the translation of nanotechnology formulations from the discovery phase into clinical trials. The protocols were developed in close collaboration with the US Food and Drug Administration (US FDA) and the National Institute of Standards and Technology (NIST) and used since 2005 to characterize over a thousand nanoformulations, including but not limited to lipid nanoparticles, liposomes, polymeric micelles, metal colloids and metal oxides, carbon nanotubes, fullerenes, dendrimers, and nucleic acid nanoparticles. The protocols can also be used for characterization of nanomaterials for other types of non-clinical studies.
