Endotoxin contamination of engineered nanomaterials: Overcoming the hurdles associated with endotoxin testing.

Nanomaterials are highly susceptible to endotoxin contamination due their large surface-to-volume ratios and endotoxins propensity to associate readily to hydrophobic and cationic surfaces. Additionally, the stability of endotoxin ensures it cannot be removed efficiently through conventional sterilization techniques such as autoclaving and ionizing radiation. In recent times, the true significance of this hurdle has come to light with multiple reports from the United States Nanotechnology Characterization Laboratory, in particular, along with our own experiences of endotoxin testing from multiple Horizon 2020-funded projects which highlight the importance of this issue for the clinical translation of nanomaterials. Herein, we provide an overview on the topic of endotoxin contamination of nanomaterials intended for biomedical applications. This article is categorized under: Therapeutic Approaches and Drug Discovery > Emerging Technologies Toxicology and Regulatory Issues in Nanomedicine > Regulatory and Policy Issues in Nanomedicine.