Title: Establishing the scientific validity of complex in vitro models: Results of a EURL ECVAM survey
Authors: BATISTA LEITE SOFIAZINCKE DOS REIS FERNANDES CIPRIANO MADALENACARPI DONATELLACOECKE SANDRAHOLLOWAY MARCELLECORVI RAFFAELLAWORTH ANDREWVIEGAS BARROSO JOAO FILIPEWHELAN MAURICE
Publisher: Publications Office of the European Union
Publication Year: 2021
JRC N°: JRC122394
ISBN: 978-92-76-28410-9 (online),978-92-76-28409-3 (print)
ISSN: 1831-9424 (online),1018-5593 (print)
Other Identifiers: EUR 30556 EN
OP KJ-NA-30556-EN-N (online),KJ-NA-30556-EN-C (print)
URI: https://publications.jrc.ec.europa.eu/repository/handle/JRC122394
DOI: 10.2760/376171
10.2760/399535
Type: EUR - Scientific and Technical Research Reports
Abstract: Complex in vitro models (CIVMs) - such as 3D cell cultures and spheroids, microphysiological systems including organ-on-chip devices, bioreactor cultures or bioprinted tissues – aim to represent higher-level anatomical and physiological aspects of human biology in experimental studies. The underpinning technologies are developing fast and the models and methods being created constitute promising approaches in several different scientific areas with many applications in research and regulatory testing. However, the successful implementation and acceptance of CIVMs is likely to require their proper characterisation, validation or qualification to demonstrate to end-users that they are fit for a particular purpose or context of use. To explore this, the EU Reference Laboratory for alternatives to animal testing (EURL ECVAM) of the European Commission's Joint Research Centre (JRC) conducted a survey to investigate stakeholder opinions and perceived needs. The outcome of the survey showed that i) there is high interest in establishing some kind of assessment approaches for CIVMs; ii) assessment approaches (even if conducted differently) should be adequate not only for regulatory use-contexts but also address applications in research; and iii) CIVMs are still under (technological and biological) development and are thus not yet mature or standardised enough to enable a consensus on how their assessment should be conducted.
JRC Directorate:Health, Consumers and Reference Materials

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