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An inter-laboratory effort to harmonize the cell-delivered in vitro dose of aerosolized materials

Anne Bannuscher, Otmar Schmid, Barbara Drasler, Alain Rohrbasser, Hedwig M. Braakhuis, Kirsty Meldrum, Edwin P. Zwart, Eric R. Gremmer, Barbara Birk, Manuel Rissel, Robert Landsiedel, Elisa Moschini, Stephen Evans Orcid Logo, Pramod Kumar, Sezer Orak, Ali Doryab, Johanna Samulin Erdem, Tommaso Serchi, Rob J. Vandebriel, Flemming R. Cassee, Shareen Doak Orcid Logo, Alke Petri-Fink, Shanbeh Zienolddiny, Martin Clift Orcid Logo, Barbara Rothen-Rutishauser

NanoImpact, Volume: 28, Start page: 100439

Swansea University Authors: Kirsty Meldrum, Stephen Evans Orcid Logo, Shareen Doak Orcid Logo, Martin Clift Orcid Logo

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DOI (Published version): 10.1016/j.impact.2022.100439

Abstract

Air-liquid interface (ALI) lung cell models cultured on permeable transwell inserts are increasingly used for respiratory hazard assessment requiring controlled aerosolization and deposition of any material on ALI cells. The approach presented herein aimed to assess the transwell insert-delivered do...

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Published in: NanoImpact
ISSN: 2452-0748
Published: Elsevier BV 2022
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URI: https://cronfa.swan.ac.uk/Record/cronfa62077
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The approach presented herein aimed to assess the transwell insert-delivered dose of aerosolized materials using the VITROCELL® Cloud12 system, a commercially available aerosol-cell exposure system. An inter-laboratory comparison study was conducted with seven European partners having different levels of experience with the VITROCELL® Cloud12. A standard operating procedure (SOP) was developed and applied by all partners for aerosolized delivery of materials, i.e., a water-soluble molecular substance (fluorescence-spiked salt) and two poorly soluble particles, crystalline silica quartz (DQ12) and titanium dioxide nanoparticles (TiO2 NM-105). The material dose delivered to transwell inserts was quantified with spectrofluorometry (fluorescein) and with the quartz crystal microbalance (QCM) integrated in the VITROCELL® Cloud12 system. The shape and agglomeration state of the deposited particles were confirmed with transmission electron microscopy (TEM). Inter-laboratory comparison of the device-specific performance was conducted in two steps, first for molecular substances (fluorescein-spiked salt), and then for particles. Device- and/or handling-specific differences in aerosol deposition of VITROCELL® Cloud12 systems were characterized in terms of the so-called deposition factor (DF), which allows for prediction of the transwell insert-deposited particle dose from the particle concentration in the aerosolized suspension. Albeit DF varied between the different labs from 0.39 to 0.87 (mean (coefficient of variation (CV)): 0.64 (28%)), the QCM of each VITROCELL® Cloud 12 system accurately measured the respective transwell insert-deposited dose. Aerosolized delivery of DQ12 and TiO2 NM-105 particles showed good linearity (R2 &gt; 0.95) between particle concentration of the aerosolized suspension and QCM-determined insert-delivered particle dose. The VITROCELL® Cloud 12 performance for DQ12 particles was identical to that for fluorescein-spiked salt, i.e., the ratio of measured and salt-predicted dose was 1.0 (29%). On the other hand, a ca. 2-fold reduced dose was observed for TiO2 NM-105 (0.54 (41%)), which was likely due to partial retention of TiO2 NM-105 agglomerates in the vibrating mesh nebulizer of the VITROCELL® Cloud12. This inter-laboratory comparison demonstrates that the QCM integrated in the VITROCELL® Cloud 12 is a reliable tool for dosimetry, which accounts for potential variations of the transwell insert-delivered dose due to device-, handling- and/or material-specific effects. With the detailed protocol presented herein, all seven partner laboratories were able to demonstrate dose-controlled aerosolization of material suspensions using the VITROCELL® Cloud12 exposure system at dose levels relevant for observing in vitro hazard responses. This is an important step towards regulatory approved implementation of ALI lung cell cultures for in vitro hazard assessment of aerosolized materials.</abstract><type>Journal Article</type><journal>NanoImpact</journal><volume>28</volume><journalNumber/><paginationStart>100439</paginationStart><paginationEnd/><publisher>Elsevier BV</publisher><placeOfPublication/><isbnPrint/><isbnElectronic/><issnPrint>2452-0748</issnPrint><issnElectronic/><keywords>Aerosol-cell exposure; Nanoparticles; Nanomaterials; Inter-laboratory comparison; Standard operating procedure (SOP); VITROCELL® Cloud12 system; DQ12; TiO2 NM-105</keywords><publishedDay>1</publishedDay><publishedMonth>10</publishedMonth><publishedYear>2022</publishedYear><publishedDate>2022-10-01</publishedDate><doi>10.1016/j.impact.2022.100439</doi><url/><notes/><college>COLLEGE NANME</college><department>Biomedical Sciences</department><CollegeCode>COLLEGE CODE</CollegeCode><DepartmentCode>BMS</DepartmentCode><institution>Swansea University</institution><apcterm>Another institution paid the OA fee</apcterm><funders>Partners AMI, RIVM, SU, and BASF SE acknowledge the funding by the PATROLS project, European Union' Horizon 2020 Research and Innovation Programme under grant agreement No: 760813. HMGU has also received funding from the European Union Horizon 2020 research and innovation program under grant agreement No. 953183 (HARMLESS project). Anne Bannuscher, Barbara Drasler, Alain Rohrbasser, Alke Petri-Fink and Barbara Rothen-Rutishauser also acknowledge the support by the Adolphe Merkle Foundation. Johanna Samulin Erdem and Shanbeh Zienolddiny acknowledge the support by the National Institute of Occupational Health, Norway. STAMI would like to acknowledge the work of Oda Haarr Foss for excellent technical assistance.</funders><projectreference/><lastEdited>2023-09-13T14:52:11.4087321</lastEdited><Created>2022-11-29T09:39:20.4008413</Created><path><level id="1">Faculty of Medicine, Health and Life Sciences</level><level id="2">Swansea University Medical School - Medicine</level></path><authors><author><firstname>Anne</firstname><surname>Bannuscher</surname><order>1</order></author><author><firstname>Otmar</firstname><surname>Schmid</surname><order>2</order></author><author><firstname>Barbara</firstname><surname>Drasler</surname><order>3</order></author><author><firstname>Alain</firstname><surname>Rohrbasser</surname><order>4</order></author><author><firstname>Hedwig M.</firstname><surname>Braakhuis</surname><order>5</order></author><author><firstname>Kirsty</firstname><surname>Meldrum</surname><order>6</order></author><author><firstname>Edwin P.</firstname><surname>Zwart</surname><order>7</order></author><author><firstname>Eric R.</firstname><surname>Gremmer</surname><order>8</order></author><author><firstname>Barbara</firstname><surname>Birk</surname><order>9</order></author><author><firstname>Manuel</firstname><surname>Rissel</surname><order>10</order></author><author><firstname>Robert</firstname><surname>Landsiedel</surname><order>11</order></author><author><firstname>Elisa</firstname><surname>Moschini</surname><order>12</order></author><author><firstname>Stephen</firstname><surname>Evans</surname><orcid>0000-0002-5352-9800</orcid><order>13</order></author><author><firstname>Pramod</firstname><surname>Kumar</surname><order>14</order></author><author><firstname>Sezer</firstname><surname>Orak</surname><order>15</order></author><author><firstname>Ali</firstname><surname>Doryab</surname><order>16</order></author><author><firstname>Johanna Samulin</firstname><surname>Erdem</surname><order>17</order></author><author><firstname>Tommaso</firstname><surname>Serchi</surname><order>18</order></author><author><firstname>Rob J.</firstname><surname>Vandebriel</surname><order>19</order></author><author><firstname>Flemming R.</firstname><surname>Cassee</surname><order>20</order></author><author><firstname>Shareen</firstname><surname>Doak</surname><orcid>0000-0002-6753-1987</orcid><order>21</order></author><author><firstname>Alke</firstname><surname>Petri-Fink</surname><order>22</order></author><author><firstname>Shanbeh</firstname><surname>Zienolddiny</surname><order>23</order></author><author><firstname>Martin</firstname><surname>Clift</surname><orcid>0000-0001-6133-3368</orcid><order>24</order></author><author><firstname>Barbara</firstname><surname>Rothen-Rutishauser</surname><order>25</order></author></authors><documents><document><filename>62077__26035__cc4fd4bb3c7d491c8a3b8734045974ca.pdf</filename><originalFilename>62077.pdf</originalFilename><uploaded>2022-12-08T12:21:21.3535332</uploaded><type>Output</type><contentLength>2546576</contentLength><contentType>application/pdf</contentType><version>Version of Record</version><cronfaStatus>true</cronfaStatus><documentNotes>© 2022 The Authors. 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spelling v2 62077 2022-11-29 An inter-laboratory effort to harmonize the cell-delivered in vitro dose of aerosolized materials bbb7bd27bfa3c6ffc73da8facfebc793 Kirsty Meldrum Kirsty Meldrum true false cfca981bdfb8492873a48cc1629def9a 0000-0002-5352-9800 Stephen Evans Stephen Evans true false 8f70286908f67238a527a98cbf66d387 0000-0002-6753-1987 Shareen Doak Shareen Doak true false 71bf49b157691e541950f5c3f49c9169 0000-0001-6133-3368 Martin Clift Martin Clift true false 2022-11-29 BMS Air-liquid interface (ALI) lung cell models cultured on permeable transwell inserts are increasingly used for respiratory hazard assessment requiring controlled aerosolization and deposition of any material on ALI cells. The approach presented herein aimed to assess the transwell insert-delivered dose of aerosolized materials using the VITROCELL® Cloud12 system, a commercially available aerosol-cell exposure system. An inter-laboratory comparison study was conducted with seven European partners having different levels of experience with the VITROCELL® Cloud12. A standard operating procedure (SOP) was developed and applied by all partners for aerosolized delivery of materials, i.e., a water-soluble molecular substance (fluorescence-spiked salt) and two poorly soluble particles, crystalline silica quartz (DQ12) and titanium dioxide nanoparticles (TiO2 NM-105). The material dose delivered to transwell inserts was quantified with spectrofluorometry (fluorescein) and with the quartz crystal microbalance (QCM) integrated in the VITROCELL® Cloud12 system. The shape and agglomeration state of the deposited particles were confirmed with transmission electron microscopy (TEM). Inter-laboratory comparison of the device-specific performance was conducted in two steps, first for molecular substances (fluorescein-spiked salt), and then for particles. Device- and/or handling-specific differences in aerosol deposition of VITROCELL® Cloud12 systems were characterized in terms of the so-called deposition factor (DF), which allows for prediction of the transwell insert-deposited particle dose from the particle concentration in the aerosolized suspension. Albeit DF varied between the different labs from 0.39 to 0.87 (mean (coefficient of variation (CV)): 0.64 (28%)), the QCM of each VITROCELL® Cloud 12 system accurately measured the respective transwell insert-deposited dose. Aerosolized delivery of DQ12 and TiO2 NM-105 particles showed good linearity (R2 > 0.95) between particle concentration of the aerosolized suspension and QCM-determined insert-delivered particle dose. The VITROCELL® Cloud 12 performance for DQ12 particles was identical to that for fluorescein-spiked salt, i.e., the ratio of measured and salt-predicted dose was 1.0 (29%). On the other hand, a ca. 2-fold reduced dose was observed for TiO2 NM-105 (0.54 (41%)), which was likely due to partial retention of TiO2 NM-105 agglomerates in the vibrating mesh nebulizer of the VITROCELL® Cloud12. This inter-laboratory comparison demonstrates that the QCM integrated in the VITROCELL® Cloud 12 is a reliable tool for dosimetry, which accounts for potential variations of the transwell insert-delivered dose due to device-, handling- and/or material-specific effects. With the detailed protocol presented herein, all seven partner laboratories were able to demonstrate dose-controlled aerosolization of material suspensions using the VITROCELL® Cloud12 exposure system at dose levels relevant for observing in vitro hazard responses. This is an important step towards regulatory approved implementation of ALI lung cell cultures for in vitro hazard assessment of aerosolized materials. Journal Article NanoImpact 28 100439 Elsevier BV 2452-0748 Aerosol-cell exposure; Nanoparticles; Nanomaterials; Inter-laboratory comparison; Standard operating procedure (SOP); VITROCELL® Cloud12 system; DQ12; TiO2 NM-105 1 10 2022 2022-10-01 10.1016/j.impact.2022.100439 COLLEGE NANME Biomedical Sciences COLLEGE CODE BMS Swansea University Another institution paid the OA fee Partners AMI, RIVM, SU, and BASF SE acknowledge the funding by the PATROLS project, European Union' Horizon 2020 Research and Innovation Programme under grant agreement No: 760813. HMGU has also received funding from the European Union Horizon 2020 research and innovation program under grant agreement No. 953183 (HARMLESS project). Anne Bannuscher, Barbara Drasler, Alain Rohrbasser, Alke Petri-Fink and Barbara Rothen-Rutishauser also acknowledge the support by the Adolphe Merkle Foundation. Johanna Samulin Erdem and Shanbeh Zienolddiny acknowledge the support by the National Institute of Occupational Health, Norway. STAMI would like to acknowledge the work of Oda Haarr Foss for excellent technical assistance. 2023-09-13T14:52:11.4087321 2022-11-29T09:39:20.4008413 Faculty of Medicine, Health and Life Sciences Swansea University Medical School - Medicine Anne Bannuscher 1 Otmar Schmid 2 Barbara Drasler 3 Alain Rohrbasser 4 Hedwig M. Braakhuis 5 Kirsty Meldrum 6 Edwin P. Zwart 7 Eric R. Gremmer 8 Barbara Birk 9 Manuel Rissel 10 Robert Landsiedel 11 Elisa Moschini 12 Stephen Evans 0000-0002-5352-9800 13 Pramod Kumar 14 Sezer Orak 15 Ali Doryab 16 Johanna Samulin Erdem 17 Tommaso Serchi 18 Rob J. Vandebriel 19 Flemming R. Cassee 20 Shareen Doak 0000-0002-6753-1987 21 Alke Petri-Fink 22 Shanbeh Zienolddiny 23 Martin Clift 0000-0001-6133-3368 24 Barbara Rothen-Rutishauser 25 62077__26035__cc4fd4bb3c7d491c8a3b8734045974ca.pdf 62077.pdf 2022-12-08T12:21:21.3535332 Output 2546576 application/pdf Version of Record true © 2022 The Authors. This is an open access article under the CC BY license true eng http://creativecommons.org/licenses/by/4.0/
title An inter-laboratory effort to harmonize the cell-delivered in vitro dose of aerosolized materials
spellingShingle An inter-laboratory effort to harmonize the cell-delivered in vitro dose of aerosolized materials
Kirsty Meldrum
Stephen Evans
Shareen Doak
Martin Clift
title_short An inter-laboratory effort to harmonize the cell-delivered in vitro dose of aerosolized materials
title_full An inter-laboratory effort to harmonize the cell-delivered in vitro dose of aerosolized materials
title_fullStr An inter-laboratory effort to harmonize the cell-delivered in vitro dose of aerosolized materials
title_full_unstemmed An inter-laboratory effort to harmonize the cell-delivered in vitro dose of aerosolized materials
title_sort An inter-laboratory effort to harmonize the cell-delivered in vitro dose of aerosolized materials
author_id_str_mv bbb7bd27bfa3c6ffc73da8facfebc793
cfca981bdfb8492873a48cc1629def9a
8f70286908f67238a527a98cbf66d387
71bf49b157691e541950f5c3f49c9169
author_id_fullname_str_mv bbb7bd27bfa3c6ffc73da8facfebc793_***_Kirsty Meldrum
cfca981bdfb8492873a48cc1629def9a_***_Stephen Evans
8f70286908f67238a527a98cbf66d387_***_Shareen Doak
71bf49b157691e541950f5c3f49c9169_***_Martin Clift
author Kirsty Meldrum
Stephen Evans
Shareen Doak
Martin Clift
author2 Anne Bannuscher
Otmar Schmid
Barbara Drasler
Alain Rohrbasser
Hedwig M. Braakhuis
Kirsty Meldrum
Edwin P. Zwart
Eric R. Gremmer
Barbara Birk
Manuel Rissel
Robert Landsiedel
Elisa Moschini
Stephen Evans
Pramod Kumar
Sezer Orak
Ali Doryab
Johanna Samulin Erdem
Tommaso Serchi
Rob J. Vandebriel
Flemming R. Cassee
Shareen Doak
Alke Petri-Fink
Shanbeh Zienolddiny
Martin Clift
Barbara Rothen-Rutishauser
format Journal article
container_title NanoImpact
container_volume 28
container_start_page 100439
publishDate 2022
institution Swansea University
issn 2452-0748
doi_str_mv 10.1016/j.impact.2022.100439
publisher Elsevier BV
college_str Faculty of Medicine, Health and Life Sciences
hierarchytype
hierarchy_top_id facultyofmedicinehealthandlifesciences
hierarchy_top_title Faculty of Medicine, Health and Life Sciences
hierarchy_parent_id facultyofmedicinehealthandlifesciences
hierarchy_parent_title Faculty of Medicine, Health and Life Sciences
department_str Swansea University Medical School - Medicine{{{_:::_}}}Faculty of Medicine, Health and Life Sciences{{{_:::_}}}Swansea University Medical School - Medicine
document_store_str 1
active_str 0
description Air-liquid interface (ALI) lung cell models cultured on permeable transwell inserts are increasingly used for respiratory hazard assessment requiring controlled aerosolization and deposition of any material on ALI cells. The approach presented herein aimed to assess the transwell insert-delivered dose of aerosolized materials using the VITROCELL® Cloud12 system, a commercially available aerosol-cell exposure system. An inter-laboratory comparison study was conducted with seven European partners having different levels of experience with the VITROCELL® Cloud12. A standard operating procedure (SOP) was developed and applied by all partners for aerosolized delivery of materials, i.e., a water-soluble molecular substance (fluorescence-spiked salt) and two poorly soluble particles, crystalline silica quartz (DQ12) and titanium dioxide nanoparticles (TiO2 NM-105). The material dose delivered to transwell inserts was quantified with spectrofluorometry (fluorescein) and with the quartz crystal microbalance (QCM) integrated in the VITROCELL® Cloud12 system. The shape and agglomeration state of the deposited particles were confirmed with transmission electron microscopy (TEM). Inter-laboratory comparison of the device-specific performance was conducted in two steps, first for molecular substances (fluorescein-spiked salt), and then for particles. Device- and/or handling-specific differences in aerosol deposition of VITROCELL® Cloud12 systems were characterized in terms of the so-called deposition factor (DF), which allows for prediction of the transwell insert-deposited particle dose from the particle concentration in the aerosolized suspension. Albeit DF varied between the different labs from 0.39 to 0.87 (mean (coefficient of variation (CV)): 0.64 (28%)), the QCM of each VITROCELL® Cloud 12 system accurately measured the respective transwell insert-deposited dose. Aerosolized delivery of DQ12 and TiO2 NM-105 particles showed good linearity (R2 > 0.95) between particle concentration of the aerosolized suspension and QCM-determined insert-delivered particle dose. The VITROCELL® Cloud 12 performance for DQ12 particles was identical to that for fluorescein-spiked salt, i.e., the ratio of measured and salt-predicted dose was 1.0 (29%). On the other hand, a ca. 2-fold reduced dose was observed for TiO2 NM-105 (0.54 (41%)), which was likely due to partial retention of TiO2 NM-105 agglomerates in the vibrating mesh nebulizer of the VITROCELL® Cloud12. This inter-laboratory comparison demonstrates that the QCM integrated in the VITROCELL® Cloud 12 is a reliable tool for dosimetry, which accounts for potential variations of the transwell insert-delivered dose due to device-, handling- and/or material-specific effects. With the detailed protocol presented herein, all seven partner laboratories were able to demonstrate dose-controlled aerosolization of material suspensions using the VITROCELL® Cloud12 exposure system at dose levels relevant for observing in vitro hazard responses. This is an important step towards regulatory approved implementation of ALI lung cell cultures for in vitro hazard assessment of aerosolized materials.
published_date 2022-10-01T14:52:13Z
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