PMID- 35612707 OWN - NLM STAT- MEDLINE DCOM- 20220810 LR - 20220818 IS - 2190-3948 (Electronic) IS - 2190-393X (Print) IS - 2190-393X (Linking) VI - 12 IP - 9 DP - 2022 Sep TI - Evaluating nanobiomaterial-induced DNA strand breaks using the alkaline comet assay. PG - 2243-2258 LID - 10.1007/s13346-022-01178-7 [doi] AB - Due to their unique chemical and physical properties, nanobiomaterials (NBMs) are extensively studied for applications in medicine and drug delivery. Despite these exciting properties, their small sizes also make them susceptible to toxicity. Whilst nanomaterial immunotoxicity and cytotoxicity are studied in great depth, there is still limited data on their potential genotoxicity or ability to cause DNA damage. In the past years, new medical device regulations, which came into place in 2020, were developed, which require the assessment of long-term NBM exposure; therefore, in recent years, increased attention is being paid to genotoxicity screening of these materials. In this article, and through an interlaboratory comparison (ILC) study conducted within the Horizon 2020 REFINE project, we assess five different NBM formulations, each with different uses, namely, a bio-persistent gold nanoparticle (AuNP), an IR-780 dye-loaded liposome which is used in deep tissue imaging (LipImage815), an unloaded PACA polymeric nanoparticle used as a drug delivery system (PACA), and two loaded PACA NBMs, i.e. the cabazitaxel drug-loaded PACA (CBZ-PACA) and the NR668 dye-loaded PACA (NR668 PACA) for their potential to cause DNA strand breaks using the alkaline comet assay and discuss the current state of genotoxicity testing for nanomaterials. We have found through our interlaboratory comparison that the alkaline comet assay can be suitably applied to the pre-clinical assessment of NBMs, as a reproducible and repeatable methodology for assessing NBM-induced DNA damage. Workflow for assessing the applicability of the alkaline comet assay to determine nanobiomaterial (NBM)-induced DNA strand breaks, through an interlaboratory comparison study (ILC). CI - (c) 2022. The Author(s). FAU - Tutty, Melissa Anne AU - Tutty MA AUID- ORCID: 0000-0002-6705-2492 AD - Nanomedicine and Molecular Imaging Group, Clinical Medicine, Trinity Translational Medicine Institute (TTMI), Trinity College Dublin, St James's Hospital, Dublin 8, Ireland. tuttym@tcd.ie. AD - Laboratory for Biological Characterization of Advanced Materials (LBCAM), TTMI, Trinity College Dublin, St James's Hospital, Dublin 8, Ireland. tuttym@tcd.ie. FAU - Vella, Gabriele AU - Vella G AD - Nanomedicine and Molecular Imaging Group, Clinical Medicine, Trinity Translational Medicine Institute (TTMI), Trinity College Dublin, St James's Hospital, Dublin 8, Ireland. AD - Laboratory for Biological Characterization of Advanced Materials (LBCAM), TTMI, Trinity College Dublin, St James's Hospital, Dublin 8, Ireland. FAU - Vennemann, Antje AU - Vennemann A AD - IBE R&D Institute for Lung Health gGmbH, Munster, Germany. FAU - Wiemann, Martin AU - Wiemann M AD - IBE R&D Institute for Lung Health gGmbH, Munster, Germany. FAU - Prina-Mello, Adriele AU - Prina-Mello A AUID- ORCID: 0000-0002-4371-2214 AD - Nanomedicine and Molecular Imaging Group, Clinical Medicine, Trinity Translational Medicine Institute (TTMI), Trinity College Dublin, St James's Hospital, Dublin 8, Ireland. prinamea@tcd.ie. AD - Laboratory for Biological Characterization of Advanced Materials (LBCAM), TTMI, Trinity College Dublin, St James's Hospital, Dublin 8, Ireland. prinamea@tcd.ie. AD - Trinity St James's Cancer Institute, Trinity College Dublin, St James's Hospital, Dublin 8, Ireland. prinamea@tcd.ie. LA - eng PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20220525 PL - United States TA - Drug Deliv Transl Res JT - Drug delivery and translational research JID - 101540061 RN - 7440-57-5 (Gold) RN - 9007-49-2 (DNA) SB - IM EIN - Drug Deliv Transl Res. 2022 Jun 19;:. PMID: 35718850 MH - Comet Assay/methods MH - DNA MH - DNA Damage MH - *Gold MH - *Metal Nanoparticles/toxicity PMC - PMC9360128 OTO - NOTNLM OT - AuNP OT - Comet assay OT - DNA damage OT - Genotoxicity OT - HepG2 OT - LipImage815 OT - Liposome OT - Nanobiomaterials OT - PACA COIS- The authors declare no competing interests. EDAT- 2022/05/26 06:00 MHDA- 2022/08/11 06:00 PMCR- 2022/05/25 CRDT- 2022/05/25 11:18 PHST- 2022/05/05 00:00 [accepted] PHST- 2022/05/26 06:00 [pubmed] PHST- 2022/08/11 06:00 [medline] PHST- 2022/05/25 11:18 [entrez] PHST- 2022/05/25 00:00 [pmc-release] AID - 10.1007/s13346-022-01178-7 [pii] AID - 1178 [pii] AID - 10.1007/s13346-022-01178-7 [doi] PST - ppublish SO - Drug Deliv Transl Res. 2022 Sep;12(9):2243-2258. doi: 10.1007/s13346-022-01178-7. Epub 2022 May 25.