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Non-animal models of epithelial barriers (skin, intestine and lung) in research, industrial applications and regulatory toxicology

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Sarah Gordon1, Mardas Daneshian2, Joke Bouwstra3, Francesca Caloni4, Samuel Constant5, Donna E. Davies6,7, Gudrun Dandekar8, Carlos A. Guzman9, Eric Fabian10, Eleonore Haltner11, Thomas Hartung2,12, Nina Hasiwa2, Patrick Hayden13, Helena Kandarova14, Sangeeta Khare15, Harald F. Krug16, Carsten Kneuer17,Marcel Leist2, Guoping Lian18,19, Uwe Marx20,21, Marco Metzger8, Katharina Ott10, Pilar Prieto22, Michael S. Roberts23, Erwin L. Roggen24, Tewes Tralau25, Claudia van den Braak26, Heike Walles8 and Claus-Michael Lehr1
1 Department of Drug Delivery, Helmholtz Institute for Pharmaceutical Research Saarland (HIPS), Helmholtz Center for Infection Research (HZI) and Department of Pharmacy, Saarland University, Saarbrücken, Germany;
2 Center for Alternatives to Animal Testing-Europe, University of Konstanz, Konstanz, Germany;
3 Division of Drug Delivery Technology, Leiden Academic Centre for Drug Research, Leiden University, Leiden, The Netherlands;
4 Università degli Studi di Milano, Department of Health, Animal Science and Food Safety (VESPA), Milan, Italy;
5 Epithelix Sàrl, Geneva, Switzerland;
6 Clinical and Experimental Sciences, Faculty of Medicine, University of Southampton, Southampton, UK;
7 NIHR Respiratory Biomedical Research Unit, University Hospital Southampton, Southampton, UK;
8 Translational Center Regenerative Therapies for Oncology and Musculoskeletal Diseases, Würzburg Branch of the Fraunhofer Institute Interfacial Engineering and Biotechnology (IGB) and Department of Tissue Engineering and Regenerative Medicine, University Hospital Würzburg, Würzburg, Germany;
9 Department of Vaccinology and Applied Microbiology, Helmholtz Center for Infection Research (HZI), Braunschweig, Germany;
10 BASF SE, Experimental Toxicology and Ecology, Ludwigshafen, Germany;
11 Across Barriers GmbH, Saarbrücken, Germany;
12 Center for Alternatives to Animal Testing, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, USA;
13 MatTek Corporation, Ashland, MA, USA;
14 MatTek In Vitro Life Science Laboratories, Bratislava, Slovak Republic;
15 Division of Microbiology, National Center for Toxicological Research, US Food and Drug Administration, Jefferson, AR, USA;
16 Empa - Swiss Federal Institute for Materials Science & Technology, St. Gallen, Switzerland;
17 German Federal Institute for Risk Assessment (BfR), Department of Pesticide Safety, Berlin, Germany;
18 Unilever Research Colworth, Sharnbrook, UK;
19 Department of Chemical and Process Engineering, University of Surrey, Guildford, UK;
20 Technical University Berlin, Germany;
21 TissUse Incorporated, Spreenhagen, Berlin, Germany;
22 EURL ECVAM, Systems Toxicology Unit, Institute for Health and Consumer Protection, European Commission, Joint Research Centre, Ispra, Italy;
23 Therapeutics Research Centre, School of Medicine, University of Queensland, Translational Research Institute, Brisbane, Queensland; University of South Australia, Adelaide, Australia;
24 3Rs Management and Consulting ApS, Lyngby, Denmark;
25 German Federal Institute for Risk Assessment (BfR), Department of Chemicals and Product Safety, Berlin, Germany;
26 Danone corporation, Nutricia Research, Utrecht, The Netherlands


Models of the outer epithelia of the human body – namely the skin, the intestine and the lung – have found valid applications in both research and industrial settings as attractive alternatives to animal testing. A variety of approaches to model these barriers are currently employed in such fields, ranging from the utilization of ex vivo tissue to reconstructed in vitro models, and further to chip-based technologies, synthetic membrane systems and, of increasing current interest, in silico modeling approaches. An international group of experts in the field of epithelial barriers was convened from academia, industry and regulatory bodies to present both the current state of the art of non-animal models of the skin, intestinal and pulmonary barriers in their various fields of application, and to discuss research-based, industry-driven and regulatory-relevant future directions for both the development of new models and the refinement of existing test methods. Issues of model relevance and preference, validation and standardization, acceptance, and the need for simplicity versus complexity were focal themes of the discussions. The outcomes of workshop presentations and discussions, in relation to both current status and future directions in the utilization and development of epithelial barrier models, are presented by the attending experts in the current report.


Keywords: in vitro models, epithelial cell culture, permeability, transport studies, cytotoxicity



ALTEX 32(4), 327-378

DOI: http://dx.doi.org/10.14573/altex.1510051

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