5. The benefits of organ-on-chip
Once the active molecule has been optimized and formulated, the treatment must be evaluated on cells, tissues and then whole organisms, to verify its safety and efficacy, before it can eventually be tested on humans in clinical trials. Traditionally, these tests have involved two-dimensional (2D) cell cultures, followed by animal trials. 2D cell cultures are not very good models of the in vivo cell environment, as they cannot mimic cell-cell and cell-environment interactions, they do not respect the gradients (gases and nutrients) present in tissues, and they cannot recreate the specific architecture of certain tissues. All this leads to changes in cell morphology and in the expression of genes, proteins and receptors, altering proliferation, differentiation, adhesion, migration and cell death, all properties that are crucial for assessing the activity and safety of new therapeutic molecules...
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The benefits of organ-on-chip
Bibliography
Standards and norms
- Microfluidic devices – Interoperability requirements concerning dimensions, connections and initial classification of devices - ISO 22916 - 2022
- Automated liquid handling systems – Part 1: Vocabulary and general requirements - ISO 23783-1 - 2022
- Microfluidics – Vocabulary - ISO 10991 - 2023
- Automated liquid handling systems – Uncertainty of measurement procedures - ISO/TR 6037 - 2024
Regulations
Commission Directive (EU) 2017/1572 of September 15, 2017 supplementing Directive 2001/83/EC of the European Parliament and of the Council as regards principles and guidelines of good manufacturing practice for medicinal products for human use (CELEX: 32017L1572)
Directory
European EMPIR project "Establishing metrology standards in microfluidic devices" (MFMET, 20NRM02): https://mfmet.eu
GDR Micro and Nanofluidics : https://www.gdrmicrofluidique.com
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