Nanoregulatory Platform

Nanoregulatory Platform

Founded in 2015 by Stefania Sabella, the mission of the group is highly interdisciplinary, requiring a strong integration of scientific knowledge of the nanomaterials to regulatory understanding. Each research activity focuses on toxicology assessments linking the physicochemical properties and functionality of emerging key enabling technologies (including manufactured nanomaterials) to specific hazard outcomes. 
Current research interests include: 
•    Biotransformation of edible novel food or constituents (nanomaterials, nanosensors, etc.) applying bio-fluids related to human exposure (e.g., simulant gastro-intestinal, lung, lysosomal fluids) and their toxicological impact;
•    Biotransformation of Nanoplastics in the oro-gastro-intestinal tract and their toxicological impact with doses relevant for human exposure;
•    Dissolution test to evaluate drug-drug interactions in complex fluids, bio-accessibility and permeability;
•    Co- and 3D- cell cultures (gastro-intestinal, lung epithelia, liver) and their interactions with bio-transformed NP/drug.
•    Tiered Testing Strategies (from simple in vitro to in vivo assays) to define homogenous classes of similar nanomaterials grouped by similarity assessment of functional properties (i.e. dissolution). The TTS is a flexible tool to provide support to read across in nanoregulatory assessments, and the applications span from human toxicological testing of new technologies to risk classification of emerging new risks in occupational settings.
 

Collaborations

Collaborations

In recent years, many National and International projects were granted on the Nanoregulatory topics for a total of funds secured of 1.5 M Euro. Several National and International scientific collaborations with regulatory and economic agencies (Italian Workers’ Compensation Authority (INAIL), Istituto Superiore della Sanità (ISS) Ministero della Salute, Organisation for Economic Co-operation and Development, OECD) were established with the aim to promote the technology transfer of the Nanoregulatory products.

Selected publications

Selected publications
  1. Tombolini F., Boccuni F., Ferrante R., Natale C., Marasco L., Mantero E., Del Rio Castillo A.E., Leoncini L., Pellegrini V., Sabella S. and Iavicoli S. “Integrated and multi-technique approach to characterize airborne graphene flakes in the workplace during the production phases” Nanoscale, accepted, 2021, https://doi.org/10.1039/D0NR07114E
  2. Cristo L.D., Boccuni F., Iavicoli S., Sabella S. “A human-relevant 3d in vitro platform for an effective and rapid simulation of workplace exposure to nanoparticles: Silica nanoparticles as case study” Nanomaterials, vol. 10, (no. 9), pp. 1-10, 2020,
  3. Ursini C. L., Fresegna A. M., Ciervo A., Maiello R., Del Frate V., Folesani G., Galetti M., Poli D., Buresti G., Di Cristo L., Sabella S., Iavicoli S., Cavallo D. “Occupational exposure to graphene and silica nanoparticles. Part II: pilot study to identify a panel of sensitive biomarkers of genotoxic, oxidative and inflammatory effects on suitable biological matrices” Nanotoxicology, 2020, :1-15, DOI: 10.1080/17435390.2020.1850903
  4. Boccuni F., Ferrante R., Tombolini F., Natale C., Gordiani A., Sabella S., Iavicoli S. “Occupational exposure to graphene and silica nanoparticles. Part I: workplace measurements and samplings” Nanotoxicology, vol. 14, (no. 9), pp. 1280-1300, 2020
  5. Di Cristo L., Grimaldi B., Catelani T., Vazquez E., Pompa P.P., Sabella S. Repeated exposure to aerosolized graphene oxide mediates autophagy inhibition and inflammation in a three-dimensional human airway model Materials Today Bio, vol. 6:100050, 2020, DOI: 10.1016/j.mtbio.2020.100050
  6. Sanchez Jimenez A., Puelles R., Perez-Fernandez M., Gomez-Fernandez P., Barruetabena L., Jacobsen N.R., Suarez-Merino B., Micheletti C., Manier N., Trouiller B., Navas J.M., Kalman J., Salieri B., Hischier R., Handzhiyski Y., Apostolova M.D., Hadrup N., Bouillard J., Oudart Y., Merino C., Garcia E., Liguori B., Sabella S., Rose J., Masion A., Galea K.S., Kelly S., Stepankova S., Mouneyrac C., Barrick A., Chatel A., Dusinska M., Runden-Pran E., Mariussen E., Bressot C., Aguerre-Chariol O., Shandilya N., Goede H., Gomez-Cordon J., Simar S., Nesslany F., Jensen K.A., van Tongeren M., Rodriguez Llopis I Safe(r) by design implementation in the nanotechnology industry, 2020 . NanoImpact, vol. 20 2019
  7. Safe innovation approach: Towards an agile system for dealing with innovations Lya G Soeteman-Hernandez, Margarita D Apostolova, Cindy Bekker, Susan Dekkers, Roland C Grafström, Monique Groenewold, Yordan Handzhiyski, Petra Herbeck-Engel, Karl Hoehener, Varvara Karagkiozaki, Sean Kelly, Annette Kraegeloh, Stergios Logothetidis, Christian Micheletti, Penny Nymark, Agnes Oomen, Thies Oosterwijk, Isabel Rodriguez-LLopis, Stefania Sabella, Araceli Sanchez Jimenez, Adrienne JAM Sips, Blanca Suarez-Merino, Isabella Tavernaro, Jacqueline van Engelen, Susan WP Wijnhoven, Cornelle W Noorlander Materials Today Communications 20, 100548 (2019)
  8. Nanomaterial grouping: Existing approaches and future recommendations Anna Giusti, Rambabu Atluri, Rositsa Tsekovska, Agnieszka Gajewicz, Margarita D Apostolova, Chiara L Battistelli, Eric AJ Bleeker, Cecilia Bossa, Jacques Bouillard, Maria Dusinska, Paloma Gómez-Fernández, Roland Grafström, Maciej Gromelski, Yordan Handzhiyski, Nicklas Raun Jacobsen, Paula Jantunen, Keld Alstrup Jensen, Agnieszka Mech, José Maria Navas, Penny Nymark, Agnes G Oomen, Tomasz Puzyn, Kirsten Rasmussen, Christian Riebeling, Isabel Rodriguez-Llopis, Stefania Sabella, Juan Riego Sintes, Blanca Suarez-Merino, Speranta Tanasescu, Håkan Wallin, Andrea Haase NanoImpact, 100182 (2019)
  9. Biotransformation and biological impact of graphene and graphene oxide during simulated oral ingestion Daniela Guarnieri, Paola Sanchez-Moreno, Antonio Esau Del Rio Castillo, Francesco Bonaccorso, Francesca Gatto, Giuseppe Bardi, Cristina Martin, Ester Vazquez, Tiziano Catelani, Stefania Sabella, Pier Paolo Pompa arXiv preprint arXiv:1903.08929 (2019) (Cover article)
  10. 10.    V. Stone, M. Führ, P.H. Feindt, H. Bouwmeester, S. Sabella, et al. “The Essential Elements of a Risk Governance Framework for Current and Future Nanotechnologies” Risk Analysis DOI: 10.1111/risa.12954, 2017
  11. Conference Paper, NanoBio&Med 2017 *Sanchez-Moreno P., Guarnieri D., Del Rio Castillo E., Bonaccorso F., *Gatto F., *Bardi G., Martin C., Vazquez E., Catelani T., * Sabella S., *Pompa P.P. “Biotransformation and biological impact of graphene-related materials during simulated oral ingestion” 2017
  12. Bove P., Malvindi MM., Sabella S. “In vitro human digestion test to monitor the dissolution of silver nanoparticles” IOP Conf. Series: Journal of Physics: Conf. Series 1823384 doi:10.1088/1742-6596/838/1/012003. 
  13. C. Carnovale, D. Guarnieri, I. De Angelis, F. Barone, S. Sabella, “Enhanced in vitro testing model for rapid risk assessment of ingested nanomaterials”, Advanced Materials TechConnect, Briefs 2017, Environmental Health & Safety of Nanomaterials, Chapter 9 pp. 317 – 320. 
  14. P. Bove, M.A.Malvindi, S.S.Kote, R.Bertorelli, M. Summa, S. Sabella “Dissolution test for risk assessment of nanoparticles: a pilot study” Nanoscale, 2017, 9, 6315 - 6326 (cover article). 

Selected Conferences

Selected Conferences
  1. S. Sabella, Istituto Superiore di Sanità, “Assorbimento orale dei nanomateriali: un approccio in vitro per il rispetto degli obblighi di informazione di cui al regolamento REACH”, seminar “Modelli di digestione simulata in vitro: stato dell’arte” 9 March 2021, On-line Workshop in Streaming (Invited)
  2. NanoHarmony, Horizon 2020 (n. 885931): International Workshop on Gap Analysis and Data Requirements to support OECD Test Guideline and Guidance Document Development. 3-5 November 2020. Session 4, S. Sabella was invited with the seminar “Data gaps identification related to intestinal fate of ingested nanomaterials” on line workshop, (invited)
  3. S. Sabella, OECD-WPMN STEERING GROUP ON TESTING AND ASSESSMENT OF MANUFACTURED NANOMATERIALS Project proposal ENV/CHEM/NANO(2019)5/ADD1/REV, 13 May, 2020 14-16 (Paris time) on-line workshop: “Integrated in vitro Approach for Intestinal Fate or Orally Ingested Nanomaterials” 13 May, on line seminar (Invited)
  4. S. Sabella “Test di dissoluzione di NPs in fluidi digestivi sintetici: quantificazione delle bio-trasformazioni e loro impatto sulla valutazione del rischio” Workshop“Il supporto scientifico alla regolamentazione europea per la gestione dei nanomateriali ingegnerizzati: il contributo italiano” Ministero della Salute, 14 febbraio 2017, Roma, IT (Invited)