Interlaboratory comparison of endotoxin contamination assessment of nanomaterials

Gary Hannon*, Bethany J. Heaton, Alexander Plant-Hately, Christopher David, Neill J. Liptrott, Ainhoa Egizabal, Ana Ayerdi-Izquierdo, Noelia Alvarez, Oihane Ibarrola, Andres Arbona Celaya, Angel Del Pozo Perez, Nerea Lazcanoiturburu, Iris Luzuriagaf, Fikirte Debebe Zegeye, Shanbeh Zienolddiny-Narui, An Jacobs, Alexandra Van Driessche, Inge Nelissen, Ibane Abasolo, Fernanda AndradeNora Ventosa, Elisabet González-Mira, Aida Carreño, Adriele Prina-Mello*

*Autor correspondiente de este trabajo

Producción científica: Contribución a una revistaArtículorevisión exhaustiva

Resumen

Endotoxin contamination is a significant hurdle to the translation of nanomaterials for biomedical applications. Multiple reports now describe that more than one-third of nanomaterials fail early pre-clinical assessment due to levels of endotoxin above regulatory requirements. Additionally, most immunological studies or in vivo studies testing nanomaterials in the literature lack inclusion of this assessment, which may lead to false-positive or false-negative results if high levels of the contaminant are present. The currently approved methods for endotoxin contamination assessment rely on enzymatic activity and wavelength absorbance as their endpoint, and many nanomaterials can interfere with such assays. For this reason, we devised an interlaboratory comparison of endotoxin contamination assessment for a range of nanomaterials to challenge the current international organization for standardization and pharmacopeia standards. Herein, we show that detected endotoxin levels could vary considerably between groups, and, in some instances, nanomaterials could both pass and fail regulatory endotoxin limits for medical devices depending on the group undertaking the assessment, all while passing all quality criteria standards. This work emphasises the requirement for multiple assays to fully assess the endotoxin levels in a nanomaterial and highlights the need for additional assays to be developed in this space.

Idioma originalInglés
Páginas (desde-hasta)21011-21020
Número de páginas10
PublicaciónNanoscale
Volumen16
N.º45
DOI
EstadoPublicada - 24 oct 2024

Huella

Profundice en los temas de investigación de 'Interlaboratory comparison of endotoxin contamination assessment of nanomaterials'. En conjunto forman una huella única.

Citar esto