The use of nanotechnology has become common in the pharmaceutical industry due to the benefits that nanoparticles offer to drug delivery, vaccines, immunotherapies, and medical devices. The Nanotechnology Characterization Laboratory has characterized over 400 nanotechnology-based concepts, 17 of which advanced to clinical trials. Among those, three advanced to marketing authorization. The laboratory also supports education and knowledge sharing by providing free consultation to extramural researchers.

We continue to develop and standardize protocols for nanoparticle characterization and collaborate with government agencies such as the U.S. Food and Drug Administration and the National Institute of Standards and Technology. We also work with standards development organizations such as ASTM International and the International Organization for Standardization.

For more information or for questions on any of the protocols, please contact the Nanotechnology Characterization Laboratory at ncl@mail.nih.gov.

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Nanotechnology Characterization Laboratory

Nanotechnology Characterization Laboratory

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Characterization process 

Our scientists subject nanoparticles to a standardized, three-tiered approach to evaluate physical and chemical properties, as well as immunology, pharmacology, and toxicology attributes. The data generated from this set of assays provides a comprehensive profile of the test nanoparticle’s physical, chemical, and biological properties and can be used to inform further development of the formulation and aid in clinical translation. 

  1. Nanoparticles are evaluated for common laboratory contaminants such as microbial contamination, endotoxins, and beta glucans. Additionally, samples are assessed for basic physicochemical properties such as size, zeta potential, and drug loading. 
  2. Nanoparticles are subjected to a more thorough analysis of physicochemical properties, in vitro drug release in physiologically-relevant matrix, and in vitro immunology and toxicology properties. 
  3. Samples advancing to stage 3 are evaluated in advanced physicochemical assays such as stability and batch-to-batch reproducibility, additional in vitro immunotoxicity assays, as well as in vivo assays for immunotoxicity, pharmacology, and toxicology.