Category: Publication

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Launch international Organ-on-Chip Standardization Roadmap at EUROoCS 2024 – First Step Towards ISO Standard?

logo with text 'EUROoCS Conference 2024' projected on a globe

On the first day of the conference of the European Organ-on-Chip Society (EUROoCS) from July 3-5 2024 in Milan, the international Organ-on-Chip Standardization Roadmap has officially been launched. Andries van der Meer (UTwente and hDMT, The Netherlands), chair of the Focus Group Organ-on-Chip (FG OoC) and also chair of EUROoCS presented the roadmap for the more than 600 participants worldwide in the Aula Magna of Politecnico di Milano.

After 2 years of hard work by 120 European experts, 10 focus group meetings, 90 working group (WG) meetings, and 3 revisions, the final version of the roadmap for Organ-on-Chip standardization is ready. The roadmap can be downloaded here

Organs-on-Chips (OoC) are microfluidic devices, containing small samples of healthy or diseased tissues from one or more organs cultured in controlled smart microenvironments. The cells behave much as they would in the organ in which they are normally found. They can thus simulate body functions. Standardization is important for the further development of this field and NEN is closely involved, in particular by running the secretariat of the Focus Group Organ-on-Chip (FG OoC) and the Dutch expert group Organ-on-Chip.

 

Recommendations

The key recommendations in the roadmap are:

  • Develop standard documents that provide harmonized terminology and definitions for important items and symbols in the OoC domain, especially including the relevant terms described in the roadmap.
  • Work on defining minimum reporting requirements for cells and biomaterials used in OoC systems. Do this in accordance with existing initiatives in this field.
    Develop comprehensive standard documents that address the key technical aspects of OoC systems.
  • Evaluate how OoC is already covered in other laboratory practices and regulatory frameworks and identify where a specific standardization approach is needed.
  • Develop documentation that outlines the specific requirements for experimental design and data management in OoC studies where these gaps are identified. Develop a framework for the qualification of OoC models and their data for specific contexts of use.
  • Develop documentation that outlines the specific requirements for the use of OoC devices in various application domains and facilitate and promote the use of OoC-based methods for specific applications.

Click image to download Roadmap

 

ISO Standard?

Now that the standardization needs in the field of Organ-on-Chip have been identified, the FG OoC advises submitting the work program for adoption to ISO. By choosing standardization at the international ISO level, stakeholders recognize the broad global interest in OoC standardization and the various initiatives already underway. This acknowledges the global value chain for OoC technologies and ensures that standards are developed with input from stakeholders worldwide. This promotes innovation, interoperability, and safety in a rapidly changing field. By leveraging international expertise and perspectives, these standards can promote harmonization, facilitate regulatory compliance, and accelerate the translation of OoC research into impactful applications for healthcare, drug discovery, and more. Simultaneously, it advises establishing the creation of a CENCENELEC Technical Committee to coordinate European interests and to keep an eye on alignment with European regulations.

Organization

The need for standardization in Organ-on-Chip (OoC) was recognized by the Joint Research Centre (JRC) of the European Commission, the European Committee for Standardization, and the European Committee for Electrotechnical Standardization (CEN and CENELEC), supported by the European Organ-on-Chip Society (EUROoCS). This resulted in a Putting Science Into Standards (PSIS) workshop ‘Organ-on-Chip: Towards Standardization’ in April 2021. In March 2022, the Focus Group Organ-on-Chip (FG OoC) was established with Andries van der Meer as chairman and NEN (Netherlands Standardization Institute) as secretariat.

Join the Organ-on-Chip Expert Group

The Dutch Expert Group Organ-on-Chip follows the work of the European Focus Group Organ-on-Chip and coordinates the Dutch input. The expert group also connects various Dutch stakeholders and provides a platform for exchange of (international) knowledge and experiences. If you are a stakeholder in this field and would like to be involved in the development of possible standards, please become a member of our expert group. There are no costs associated with this membership.

More Information?

If you would like more information on the subject, or if you are considering becoming a member of the expert group, please contact Suzie Noten (suzie.noten@nen.nl) or Lysette Meuleman (lysette.meuleman@nen.nl).

Source: NEN / CENELEC

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New publication on designing microphysiological systems for cardiac modelling

Researchers from the Centre of Excellence in Body-on Chip Research at Tampere University (Finland) have published a review regarding designing  microphysiological systems for cardiac modelling. The review is titled ‘Building blocks of microphysiological system to model physiology and pathophysiology of human heart’.

The centre focuses on modelling of hypoxia in cardiac ischemia, brain stroke and obesity related conditions. Developing chip platforms and monitoring technologies for controlling and monitoring oxygen as well as hydrogel development are also the core actions of the centre.

Link to centre’s website.

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EURL ECVAM Status Report 2021 on Alternative Methods published

The European Union Joint Research Centre for Alternatives to Animal Testing (EURL ECVAM) has issued its 2021 ‘Status Report on the Development, Validation and Regulatory Acceptance of Alternative Methods and Approaches’.

The 2021 EURL ECVAM status report describes research, development and validation activities, as well as initiatives that promote the uptake and use of non-animal methods and approaches in science and regulation. The principle of the Three Rs, i.e. Replacement, Reduction and Refinement of animal use in basic, applied and translational research, as well as for regulatory purposes is firmly anchored in EU legislation, with full replacement of animal testing being the ultimate goal. New approach methodologies including a variety of innovative technologies, such as in vitro methods using 3D tissues and cells, organ-on-chip, computational models (including artificial intelligence) and ‘omics (genomics, proteomics, metabolomics), are developed, evaluated and integrated in assessment frameworks with a view to improve the efficiency and effectiveness of hazard and risk assessment of chemicals and products in a variety of regulatory contexts. Important activities to promote the development and use of non-animal approaches are also pursued in the areas of basic and applied research, where most of the animals are used, as well as for education purposes.

Download and read the full report here:

Sources:

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Special issue Stem Cell Reports on Organs-on-Chip

The special issue of Stem Cell Reports on Organs-on-Chip is the first result of the collaboration between the International Society for Stem Cell Research (ISSCR) and the European Organ-on-Chip Society (EUROoCS). In the editorial the guest editors Christine Mummery and Peter Loskill, past chair and current chair of EUROoCS, welcome the readers of Stem Cell Reports to become inspired by the use of stem cell-derived tissues and organoids in Organ-on-Chip/microphysiological systems. The special issue includes commentaries on the future perspectives of Organ-on-Chip, interviews with pioneers in the field, and other interesting reports and articles. All papers are open access.

Table of contents special issue

Interested in submitting a paper to the next regular issue of Stem Cell Reports? Look at the benefits for EUROoCS ) members below.

Benefit for EUROoCS members
EUROoCS members benefit from a discount for publication of their manuscript in Stem Cell Reports. They will be charged the ISSCR-member rate of $3300 (the non-member rate is $3800). Sign up to become a member.

 

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Multiorgan-on-a-Chip: A Systemic Approach To Model and Decipher Inter-Organ Communication

Multiorgan-on-a-chip (multi-OoC) technology has great potential to metamorphose research in biology and medicine by providing holistic and personalized models for understanding and treating multisystem diseases.

Figure: Various Multiorgan-on-a-Chip Combinations as a Model of Human Physiology and Pathophysiology in Different Biomedical Applications. Figure reproduced from Picollet-D’hahan et.al. , Trends in Biotechnology  https://doi.org/10.1016/j.tibtech.2020.11.014 (CC BY 4.0)

This paper addresses the need for comprehensive multiorgan models with a systemic dimension ,highlights scenarios in which multiorgan models are advantageous and gives an overview of existing multi-OoC platforms. Also the remaining challenges for the realization of multi-OoC platforms and their worldwide adoption are discussed here.

About the authors
The publication was co-written by two Members of the AMBER lab (University of Twente, NL), Séverine Le Gac and Agnieszka Zukowska and two Members of the CEA Grenoble, France, Nathalie Picollet-D’hahan (Organizing Committee EUROoCS 2021 & Chair EUROoCS 2022) and Iris Lemeunier.

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Organ-on-Chip: Playing LEGO® With Mini-Organs to Reduce Animal Testing and Make Medicines Safer

This publication in the journal Frontiers for Young Minds is specifically designed to an audience of kids and teenagers.

“Figure reproduced from Rogal et al. Front. Young Minds 2020, 8, 544390 (CC BY 4.0)”

In an easy-to-understand language the Organ-on-Chip technology is introduced and the basic underlying concepts described. Examples and descriptive pictures of Organ-on-Chip modules are provided as well as an overview of applications.
The publication can be downloaded (free download) in pdf (https://kids.frontiersin.org/article/10.3389/frym.2020.544390)

Abstract
Have you ever pictured yourself as a LEGO®-mini-figure? That is pretty cool, right?! But now, instead of picturing yourself as an astronaut, superhero, or elf-figure, try to imagine your own body being miniature and built from LEGO®–one brick for each of your organs. Sound weird? Let us explain why a mini LEGO®-version of you could be extremely useful and could become reality in the future. Such technology might help end testing that uses laboratory animals and help your doctors understand your disease. We use people’s cells and small plastic housings to build mini-organs the size of small LEGO®-bricks, such as a beating heart or energy-storing fat tissue. Similar to playing LEGO®, we can also connect different organ-bricks and study how they talk and work with each other. In this article, we will tell you how this all works and why it is so much better than animal experiments.

About the authors and editors
The publication was composed by Members of the µOrgano Lab (University of Tübingen) Julia Rogal, Madalena Cipriano and Peter Loskill (Vice-Chair EUROoCS).

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FDA Report on Advancing Alternative Methods

Dr. Susanne Fitzpatrick, senior advisor for toxicology at FDA about the report: ‘The report entitled Advancing Alternative Methods at FDA was developed by the FDA Alternative Methods Working Group to highlight the significant progress FDA scientists have made in our product centers and offices in laying the groundwork for integrating alternative approaches into FDA regulatory programs. It demonstrates FDA’s strong commitment to reducing animal testing and to encouraging stakeholders to continue partnering with FDA to achieve this important goal.

FDA scientists have vast expertise and experience using available tools to make tough scientific decisions about the safety and effectiveness of the multitude of therapeutic products in our regulatory portfolio. Many of the important research activities on alternative methods described in this report are being conducted in FDA laboratories, and many of these include collaborations with outside stakeholders. Results from these ground-breaking research activities add to the body of knowledge that FDA can draw upon as it evaluates regulatory acceptance criteria for new alternative methods.

FDA believes partnerships between our diverse programs and outside stakeholders are essential to furthering progress in developing strong alternative approaches. FDA is open to dialogue from all sectors of the population because we believe it will strengthen our scientific and regulatory thinking’.

The report is available here.

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White paper: Emerging Medical Domains for the ECS industry now available

The Health.E lighthouse recently published a White Paper on the emerging medical domains for the electronics components and systems industry and the many opportunities that lie ahead.

Health care is changing. It is becoming more and more decentralized and personalized, and there will be an increased emphasis on prevention. These changing are triggering the development of new medical devices and solutions that are emerging at the fading borders between the Electronics, MedTech and Pharmaceutical industries.

To create awareness of the opportunities these emerging medical domains offer from a perspective of the electronics industry, the Health.E lighthouse has published a white paper in which thirteen emerging domains ranging from Organ-on-Chip to surgical robots have been identified. The topics are presented in accessible format, addressing the economic and societal relevance with suggestions for further reading.

The Health.E White paper on “Emerging Medical Domains for the ECS industry” can be downloaded here (pdf).

The Health.E lighthouse is an initiative of the ECSEL joint undertaking funding platform. Its mission is to accelerate innovation in medical devices by promoting the adoption of open technology platforms.

Visit the Health.E website to learn more about the mission and the vision of the lighthouse and follow them on LinkedIn.

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‘Mini Organs-on-Chips: Towards new research models for studying disease and finding treatments’.

The Dutch Foundation ‘Biosciences and Society’ has launched the booklet entitled ‘Mini Organs-on-Chips: Towards new research models for studying disease and finding treatments’.

This publication in the series of so-called ‘Cahiers’ explains to a large audience, in an easy-to-understand language, what these promising Organs-on-Chips are, and what they can do and cannot (yet) do for health, and wellbeing of society and economy.
A state-of-the-art overview is given of what can be expected from this technology, now and in the future. Examples illustrating the potential to improve and accelerate drug development, to enable personalized treatment and to reduce the number of animal experiments are included.

The booklet can be downloaded (free download) in pdf or ordered as hard-copy (€7,50).
The booklet is an initiative of the Institute for human Organ and Disease Model Technologies (hDMT) and contains contributions from many of the top research groups in the Organ-on-Chip field in the Netherlands.

Abstract
Despite decades of research, there are still no drugs for many diseases. And the drugs that are available may only be effective in some patients or cause unwanted side-effects. Organ-on-Chip technology with human cells is a promising approach to address these problems. The models contain living human cells from specific organs that simulate the function, dynamics and structure of human organs in sickness and in health. Organ-on-Chip models could not only improve but also accelerate the drug development process and reduce its costs. In addition, this technology contributes to reducing the use of laboratory animals.

About the authors and editors
The booklet Mini Organs-on-Chips was composed by Janny van den Eijnden-van Raaij (managing director hDMT & secretary/treasurer EUROoCS), Berend van Meer (researcher LUMC and business developer Organ-on-Chip Center Twente, UTwente), Christine Mummery (Professor of Developmental Biology, Dept. of Anatomy & Embryology, LUMC & Chair EUROoCS) and Astrid van de Graaf (editor-in-chief and freelance science journalist).

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Review ‘Organs-on-Chips: into the next decade’ published

A few years after the international Keystone Symposium in April 2018 in Big Sky, Montana, USA co-organized by Christine Mummery (EUROoCS Chair), a review is published that provides a snapshot of the fast-evolving Organ-on-Chips technology, discusses current applications and caveats for their implementation, and offers suggestions for directions in the next decade.

Abstract: Organs-on-chips (OoCs), also known as microphysiological systems or ’tissue chips’ (the terms are synonymous), have attracted substantial interest in recent years owing to their potential to be informative at multiple stages of the drug discovery and development process. These innovative devices could provide insights into normal human organ function and disease pathophysiology, as well as more accurately predict the safety and efficacy of investigational drugs in humans. Therefore, they are likely to become useful additions to traditional preclinical cell culture methods and in vivo animal studies in the near term, and in some cases replacements for them in the longer term.

In the past decade, the OoC field has seen dramatic advances in the sophistication of biology and engineering, in the demonstration of physiological relevance and in the range of applications. These advances have also revealed new challenges and opportunities, and expertise from multiple biomedical and engineering fields will be needed to fully realize the promise of OoCs for fundamental and translational applications.

Ref: Low, L.A., Mummery, C., Berridge, B.R. et al. Organs-on-chips: into the next decade. Nat Rev Drug Discov (2020), Doi 10.1038/s41573-020-0079-3