Cited by 1563D Printing in Biomedical ResearchMicrofluidic and Capillary Electrophoresis ApplicationsTissue Engineering and Regenerative Medicine

Standardisation needs for organ on chip devices

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Piergiovanni, Monica, Leite, Sofia B., Corvi, Raffaella, Whelan, Maurice·2021·Lab on a Chip

Abstract

Organ on chip (OoC) devices represent the cutting edge of biotechnologies, combining advanced cell and tissue culture with microengineering. OoC is accelerating innovation in the life sciences and has the potential to revolutionise many fields including biomedical research, drug development and chemical risk assessment. In order to gain acceptance by end-users of OoC based methods and the data derived from them, and to establish OoC approaches as credible alternatives to animal testing, OoC devices need to go through an extensive qualification process. In this context, standardisation can play a key role in ensuring proper characterisation of individual devices, benchmarking against appropriate reference elements and aiding efficient communication among stakeholders. The development of standards for OoC will address several important issues such as basic terminology, device classification, and technical and biological performance. An analysis of technical and biological aspects related to OoC is presented here to identify standardisation areas specific for OoC, focusing on needs and opportunities. About 90 standards are already available from related fields including microtechnologies, medical devices and in vitro cell culture, laying the basis for future work in the OoC domain. Finally, two priority areas for OoC are identified that could be addressed with standards, namely, characterisation of small molecule absorption and measurement of microfluidic parameters.

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Cited by

Sorted by citations

Authors
Piergiovanni, M., Leite, S. B., Corvi, R., & Whelan, M.
Affiliations
European Commission (BE)
Corresponding author
Piergiovanni, Monica
Venue
Lab on a Chip
Published
2021
Volume
21
Issue
15
Pages
2857-2868
ISSN
  • 1473-0189 (ISSN-L)
  • 1473-0197
OpenAlex
W3179241489
Cited by
155
References
30
Citations by year
2026: 46 · 2025: 27 · 2024: 32 · 2023: 27 · 2022: 18 · 2021: 5
FWCI
6.22
Type
journal article
Language
en
Open access
Locations
  • Lab on a Chip (publishedVersion, cc-by)
  • PubMed (publishedVersion)
Topics
  • Physical Sciences › Engineering › Biomedical Engineering › 3D Printing in Biomedical Research
  • Physical Sciences › Engineering › Biomedical Engineering › Microfluidic and Capillary Electrophoresis Applications
  • Health Sciences › Medicine › Surgery › Tissue Engineering and Regenerative Medicine
Keywords
organ-on-a-chip, standardization, device qualification, alternatives to animal testing, device classification, terminology, device characterization, reference elements, microfluidics, in vitro cell culture, drug development, chemical risk assessment
MeSH terms
Animals, Cell Culture Techniques, Oligonucleotide Array Sequence Analysis, Microfluidics, Lab-On-A-Chip Devices

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