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Standardisation needs for organ on chip devices.

Monica Piergiovanni1, Sofia B Leite1, Raffaella Corvi1

  • 1European Commission, Joint Research Centre (JRC), Ispra, Italy. monica.piergiovanni@ec.europa.eu.

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Summary
This summary is machine-generated.

Standardizing organ on chip (OoC) devices is crucial for their acceptance as alternatives to animal testing. Developing standards for terminology, classification, and performance will accelerate innovation in life sciences and drug development.

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Area of Science:

  • Biotechnology and Life Sciences
  • Microengineering and Cell Culture

Background:

  • Organ on chip (OoC) devices integrate advanced cell culture with microengineering, driving innovation in biomedical research, drug development, and risk assessment.
  • Widespread adoption of OoC technologies requires rigorous qualification processes and standardized methodologies to ensure credibility, particularly as alternatives to animal testing.

Purpose of the Study:

  • To analyze the technical and biological aspects of OoC devices to identify specific areas for standardization.
  • To explore the needs and opportunities for developing standards that facilitate the acceptance and reliable application of OoC technologies.

Main Methods:

  • Review and analysis of existing standards in related fields (microtechnologies, medical devices, in vitro cell culture).
  • Identification of critical parameters and aspects of OoC devices requiring standardization.

Main Results:

  • Approximately 90 relevant standards exist in adjacent fields, providing a foundation for OoC standardization.
  • Two priority areas for standardization were identified: characterization of small molecule absorption and measurement of microfluidic parameters.

Conclusions:

  • Standardization is essential for the proper characterization, benchmarking, and communication of OoC devices.
  • Developing standards for OoC will enhance their reliability, facilitate regulatory acceptance, and support their role in replacing animal testing.