Overview
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.
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.
- 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.
- 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.
- 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.
Protocols
- Sterility, endotoxin, and beta-glucan
- Assess common contaminants such as microbial contamination, endotoxin levels, and beta-glucan levels in the test formulation.
- Physicochemical characterization
- Assess attributes such as size distribution, surface characteristics, composition, purity, and stability.
- Immunotoxicity
- Evaluate potential hematotoxicity and immunotoxicity in vitro using freshly drawn human blood.
- In vitro efficacy
- Evaluate the efficacy of select test formulations in vitro.
- Toxicology
- Probe general toxicity of the formulation under in vitro test conditions.
- Pharmacology
- Evaluate drug release of the test formulation in vitro using physiologically relevant matrix.
Access our protocol library.