Standardisation needs for organ on chip devices
Open accessAbstract
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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The key aspects of a model that need to be defined and supported by data are the context-of-use, readouts, robustness, and limitations.
“Overall, the key aspects of a model that need to be defined and supported by data are the context-of-use, readouts, robustness, and limitations.”
From Considering future qualification for regulatory science in the early development of microphysiological systems: a case study of microthrombosis in a Vessel-on-Chip (2024) · cites this paper as Piergiovanni et al., 2021
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- Authors
- Piergiovanni, M., Leite, S. B., Corvi, R., & Whelan, M.
- Affiliations
- European Commission (BE)
- Corresponding author
- Piergiovanni, Monica
- Venue
- Lab on a Chip
- Publisher
- Royal Society of Chemistry (RSC)
- 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
- hybrid
- doi.org
- 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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