Year: 2024
Type: article
Abstract: 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.
Source: Nanoscale
DOI: 10.1039/d4nr02821j
Authors: 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 Luzuriaga, Fikirte Debebe Zegeye, Shanbeh Zienolddiny-Narui, An Jacobs, Alexandra Van Driessche, Inge Nelissen, Ibane Abasolo, Fernanda Andrade, Nora Ventosa, Elisabet González-Mira, Aida Carreño, Adriele Prina-Mello
Institutions: Trinity College Dublin, University of Liverpool, Centre of Excellence for Long-acting Therapeutics, Tecnalia, National Institute of Occupational Health, Flemish Institute for Technological Research, Universitat Autònoma de Barcelona, Instituto de Salud Carlos III, Vall d'Hebron Institut de Recerca, Biomedical Research Networking Center in Bioengineering, Biomaterials and Nanomedicine, Institut de Ciència de Materials de Barcelona, Advanced Materials and BioEngineering Research
Language: English
Subfield: Materials Chemistry
Field: Materials Science
Domain: Physical Sciences
Open Access status: hybrid
Funder: European Commission
OpenAlex ID: W4403736808