Setting out a roadmap for standardisation of organ on chip technology

Organ-on-chip (OoC) is an integration of biotechnology with micro-fluidic chips and sensors to build miniaturised versions of human organs, such as the lung, heart, or liver. These devices contain living human cells that replicate the functioning of real organs, allowing researchers to study how diseases affect human tissues and to develop novel therapies.

Although OoC is being primarily applied for the development of new medicines, it is also growing in importance for safety testing of chemicals used in consumer goods such as cosmetics. In biomedical research, OoC devices have the potential to reduce and replace animal experiments, particularly in areas where animals are poor models of human physiology and disease.

Making personalised medicine accessible to everyone

OoC could have an important impact on healthcare, allowing clinicians to identify customised treatments based on the unique characteristics of each patient.

For example, a cancer patient could provide a biopsy to recreate their own tumour on a chip. This chip would then be exposed to different drug regimens to find the combination that works best for them. The same could be applied to patients suffering from rare diseases.

How the JRC is helping to make this happen

At present, OoC technology is not fully integrated into drug development and clinical practice. For that to happen, standards are needed to ensure that devices are reliable and effective, i.e. that the data they provide can be used to ensure the safety and efficacy of new medicines. Standardisation will also support the development of a strong industrial ecosystem around this innovative biotechnology.

JRC experts have identified standardisation needs and opportunities in the OoC domain. They also contributed to creating a dedicated CEN-CENELEC Focus Group, with the support of EUROoCS and NEN, and actively took part in it. This Focus Group has developed and published a roadmap with key recommendations for future standardisation activities.

The roadmap highlights the importance of a global endeavour to develop standards for OoC devices. To reach such a broad agreement, it suggests collaboration with the International Organization for Standardization (ISO), which has recently set up a new Subcommittee on 'Microphysiological systems and Organ-on-Chip' (ISO/TC 276/SC2) under Technical Committee (TC) 276 - Biotechnology.

The roadmap also pinpoints key areas that, if supported with globally accepted standards, would boost the development and diffusion of OoC technology. For example, it mentions the need to settle on standard methods for characterising the materials used in OoCs and for checking their biocompatibility, i.e. ensuring that these materials are safe and function effectively when used in conjunction with living tissues.

Once standards for OoC are available, they can be used by both industry and regulators to evaluate the use of these devices for different purposes, such as the safety assessment of chemicals used in many different products, the efficacy testing of new drugs, personalised medicine, and the reduction and replacement of animals used in biomedical research.With standards on the way, this technology is one step closer to reaching its full potential for the benefit of all.

As pointed out in the recent Commission report on The future of European competitiveness - A competitiveness strategy for Europe, embracing such technologies can help the EU address the growing competitiveness gap in the pharmaceutical sector by expanding its capacity to conduct cutting-edge research and development activities. This innovative biotechnology also supports the ambitions of the EU Biotechnology Act to boost the EU's biotechnology and biomanufacturing sector. These technologies rank among our century's most promising innovations and have the potential to enhance our health, agriculture, forestry, energy, food, feed, and industrial sectors.

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