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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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Successful conclusion of Moore4Medical project

The power of Open Technology Platforms for Organ-on-Chip applications

After the successful final review in Maastricht (NL) at the end of September 2023, the 3-year KDT-JU project Moore4Medical has reached its very successful conclusion. Under the expert leadership of Sieger Swaving, Ronald Dekker and Erik van den Zeijden (Philips), the 68 consortium partners of Moore4Medical have convincingly shown how open technology platforms can be beneficially deployed to advance multiple biomedical domains, such as implantable devices, ultrasound monitoring, drug attrition, surgical devices, and not least Organ-on-Chip.

With the contribution of 24 European partners * (see below)  the second work package of Moore4Medical led by Massimo Mastrangeli (TU Delft) specifically developed three open technology platforms for Organs-on-Chip: the Smart Multi-Well Plate (SMWP), the High-Definition electro-Physiology Plate (HD e-Phys) and the Smart (multi-well plate) Lid. The platforms were developed from design and architecture through implementation, fabrication and assembly, to biological validation in relevant settings. They embody recommendations from the European Organ-on-Chip roadmap for ease of use, standardization and industrially scalable manufacturing. The SMWP in particular captures the power of Organ-on-Chip devices under the familiar aspect of a multi-well plate (see illustration). It combines end user-defined configurability of Organ-on-Chip devices with fluidic autonomy afforded by onboard piezoelectric micropumps and compatibility with established laboratory workflows.

Moore4Medical has also prepared the ground for follow-up projects that can capitalize on its many achievements and insight, such as the NEXTGEN HIGHTECH program (domain Biomedical Production Technologies) in the Netherlands and the KDT-JU UNLOOC project (under evaluation). For more information about the Moore4Medical project watch the M4M video:

*  24 European partners – TU Delft (NL), Micronit (NL), Multi Channel System (DE), Philips (NL), Fraunhofer EMFT (DE), imec (BE), CSEM (CH), InSphero (CH), Besi Netherlands (NL), Besi Austria (AT), EVG (AT), TU Eindhoven (NL), INESC-MN (PT), ITAV (PT), IMT (RM), Menarini Silicon Biosystems (IT), IISA (ES), BEOnChip (ES), BI/OND (NL), Microfluidic ChipShop (DE), TNO Holst Centre (NL), CER (HU), AEDUS (HU), Universita’ de Zaragoza (ES).

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The ISSCR Releases Global Standards to Enhance Rigor and Reproducibility of Stem Cell Research

The International Society for Stem Cell Research (ISSCR) released the ISSCR Standards for Human Stem Cell Use in Research, an international collaboration aimed at enhancing rigor in preclinical research and ultimately strengthening the pipeline of therapies for patients. Christine Mummery and colleagues were among the many dedicated expert scientists who established this document. These new guidelines will also provide invaluable aid to authors, journal editors, and reviewers in the stem cell field when considering publications.

“This nearly two-year initiative is groundbreaking for the global stem cell research community,” said Haifan Lin, ISSCR president. “The international standards will make a big difference in the quality of science that is performed and published worldwide.”

The ISSCR is the preeminent international stem cell research society with a reputation for scientific and ethical rigor and has produced field-shaping documents such as the Guidelines for Stem Cell Research and Clinical Translation. The current initiative, which establishes the minimum characterization and reporting criteria for scientists, students, and technicians in basic research laboratories working with human stem cells, is led by an international taskforce of scientists chaired by Tenneille Ludwig, WiCell Research Institute, USA and Peter Andrews, University of Sheffield, UK. The ISSCR’s standards for basic and preclinical research draws from previous work to improve the reproducibility of research using pluripotent stem cells, such as that from the International Stem Cell Initiative (ISCI) and the International Stem Cell Banking Initiative (ISBCI), and address tissue stem cells and stem cell-derived model systems with the overall goal of improving reproducibility of experiments from lab to lab and from cell line to cell line.

“The ISSCR Standards represent a huge step forward in articulating Best Practice for use of stem cells in research,” said Tenneille Ludwig, co-chair of the taskforce that developed the recommendations. “When adopted, these basic principles will help drive rigor and reproducibility within the laboratory and improve both the quality and rate of science in our field.  It was an honor to work with such an experienced, dedicated, passionate group of true stem cell legends to establish this consensus document. The commitment to collaborative effort ultimately resulted in a strong document that will drive the field forward.”

One of the most impactful outcomes of the initiative is the development of the “Reporting Practices for Publishing Results with Human Pluripotent and Tissue Stem Cells” checklist. The checklist is intended to help scientists, reviewers, and editors prepare and assess manuscripts for inclusion of critical details relevant to work with pluripotent stem cells (PSCs) and tissue stem cells (TSCs) with the goal of increasing the rigor and reproducibility of research through reporting.

“Stem Cell Reports views these new guidelines as an invaluable aid to authors, journal editors, and reviewers in the stem cell field,” said Martin Pera, Editor-in-Chief of Stem Cell Reports. “At our journal, we will be introducing the checklist for authors that accompanies the guidelines on a trial basis soon and soliciting their feedback along with that of reviewers and our Editorial Team. My colleagues and I feel this is a major step forward in ensuring rigor and reproducibility in all areas of stem cell research.”

Learn more about the evolution of the recommendations made in the ISSCR Standards by reviewing the society’s open access Standards webinars on ISSCR.digital and attending the ISSCR 2023 Annual Meeting in Boston, USA 14-17 June 2023. Visit ISSCR.org/standards-document for the full text and to download the PDF of the ISSCR Standards for Human Stem Cell Use in Research and the “Reporting Practices for Publishing Results with Human Pluripotent and Tissue Stem Cells” checklist.

The ISSCR Standards initiative is supported through contributions by Burroughs Wellcome Fund (BWF), Doris Duke Charitable Foundation (DDCF), and the Simons Foundation Autism Research Initiative (SFARI). Learn more about their support.

About the International Society for Stem Cell Research (www.isscr.org)
With more than 4,600 members from 80 countries worldwide, the International Society for Stem Cell Research is the preeminent global, cross-disciplinary, science-based organization dedicated to stem cell research and its translation to the clinic. The ISSCR mission is to promote excellence in stem cell science and applications to human health. Additional information about stem cell science is available at A Closer Look at Stem Cells, an initiative of the society to inform the public about stem cell research and its potential to improve human health.

 About Burroughs Wellcome Fund

The Burroughs Wellcome Fund (BWF) serves and strengthens society by nurturing a diverse group of leaders in biomedical sciences to improve human health through education and powering discovery in frontiers of greatest need. BWF was founded in 1955 as the corporate foundation of the pharmaceutical firm Burroughs Wellcome Co. In 1993, a generous gift from the Wellcome Trust in the United Kingdom, enabled BWF to become fully independent from the company, which was acquired by Glaxo in 1995. 

 About Doris Duke Charitable Foundation

The mission of the Doris Duke Charitable Foundation is to improve the quality of people’s lives through grants supporting the performing arts, environmental conservation, child well-being and medical research, and through preservation of the cultural and environmental legacy of Doris Duke’s properties. The foundation’s Medical Research Program supports clinical research that advances the translation of biomedical discoveries into new preventions, diagnoses and treatments for human diseases. To learn more about the program, visit www.ddcf.org.

Source: ISSCR
Download the new standards here

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OVER €3 MILLION FOR ORGAN-ON-CHIP DEVELOPMENT

The Dutch Research Council (NWO) is investing about 22.7 million euros in seven projects for innovative scientific infrastructure. For the University of Twente over 3 million euros will go to the Organ-on-Chip Development Center (hDMT INFRA OoCDev) led by Andries van der Meer. In addition to hDMT INFRA StemCells, this is the second Service Center of Expertise that will be developed within hDMT to accelerate the implementation of Organ-on-Chip technology.

Organs-on-chips are cultured mini-organs that are used to study the safety and efficacy of food and medical drugs. The development of new organs-on-chips is complex, because it relies on expertise in microfabrication, microfluidics, cell culture, tissue engineering and microscopy. The new facility ‘hDMT INFRA OoCDev’ will enable the development of innovative organs-on-chips by bringing together groundbreaking infrastructure and technical expertise. The facility will be embedded in a national organization and will play an important role in boosting the development of even more realistic organs-on-chips.

This facility will make it possible to develop organs-on-chips that are truly next generation, with working three-dimensional tissues, blood flow and dynamic loading.

The Organ-on-Chip Development Centre provides a central location for this pioneering work, not only for local researchers, but precisely for all scientists from other institutes affiliated to the national ‘Institute for human Organ and Disease Model Technologies (hDMT)’.

Recently another grant of almost 13.5 million euros has been awarded to hDMT INFRA StemCells from the National Roadmap Large-Scale Scientific Infrastructure of NWO. This funding will be used to establish a national state-of-the-art infrastructure, led by hDMT, that will provide support in setting up and conducting studies on stem cells to all researchers across the Netherlands and beyond.

RESEARCH INFRASTRUCTURE: NATIONAL CONSORTIA

The projects are awarded in the research programme ‘Research Infrastructure: national consortia’, the new name of NWO Investment Grant Large. With this funding, NWO is strengthening the scientific infrastructure that Dutch knowledge institutions can make available to the research community. Scientists from throughout the Netherlands often work together and with international partners within the projects where the new facilities will be realised. Other investments from NWO are for: Phased array radar for extreme weather analysis and prediction (PHARA), Shining light on atomic-scale processes (SHINE), The Africa Millimetre Telescope: Making colour movies of black holes, The Dutch Comprehensive Childhood Cancer Commons: A national resource for tackling pediatric cancer worldwide, Expanding the new window upon our Universe: gravitational-wave discoveries with Advanced Virgo Plus and Pulsed Laser Deposition Lab for Energy Research: New materials for green chemistry and transport.

Source: UTwente, NWO

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First Italian OoC National Congress

On May 4th and 5th, 2023, the Italian Organ-on-Chip Society (SIOoC) will organize its first National Congress. The event will be held at the National Research Council premises in Rome, with an expected participation of more than 110 delegates from across the Country.

The 2-day event will offer 7 scientific thematic sessions, each with an invited keynote speaker, as well as rapid-fire presentations dedicated to poster presentations from young researchers.

Italian researchers, pharmaceutical, biotech and technological companies, as well as representatives of the regulatory agencies, will discuss in a dedicated round table the opportunities and perspective of the OoC field in Italy, and its positioning in the value chain from research to clinics.

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EUROoCS RAB presents resources for Organ-on-Chip validation and qualification at the EUROoCS 2022 Conference

The Regulatory Advisory Board (RAB) of EUROoCS is supporting activities in relation to the regulatory aspect of Organ-on-Chip (OoC) approaches. The RAB has worked closely together with the EU Reference Laboratory for alternatives to animal testing (EURL ECVAM) – an integral part of the European Commission’s Joint Research Centre (JRC) – on compiling a set of resources. This resource list is expected to be used as a reference point for the EUROoCS community in the development of OoC models towards their qualification and regulatory acceptance.

The catalogue incorporates two different – but interconnected – set of resources:

  1. a carefully selected and curated resource list of relevant reading documents (including documents, guidelines, reflection papers, guidance documents and reports published by ECHA, EFSA, EURL ECVAM, EMA, FDA, ICH and OECD), as well as other pertinent resources (peer-reviewed publications, workshop reports etc);
  2. a set of Frequently Asked Questions related to the main regulatory areas where OoC approaches might be of relevance (chemical, drug and food safety).

The resource list and the Frequently Asked Questions will be presented for the first time during the EUROoCS Annual Meeting (4/7/22, Session I on Qualification & Standardization) and can be found and downloaded here:

 

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EUROoCS Conference 2022 update

Due to the overwhelming number of EUROoCS 2022 participants (close to 500 instead of 250 expected), due to the logistical difficulty to move these people by cable car, due to the limited capacity of La Bastille, due to the resumption of the Covid pandemic (preference for an open space), we had to modify the location of our gala dinner, but we kept the jazz band and our surprise!
The social evening with the gala dinner (dress code: casual) will now take place at the famous Olympic Stadium in Grenoble, surrounded by the mountains, which is a fabulous place to renew or start national or international friendships and has plenty room for all participants. More information will follow during the conference.

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EUROoCS Conference 2022 update

The Scientific Program Committee has developed an exciting program for the EUROoCS 2022 conference. From the 218 submitted abstracts 56 oral presentations have been selected and 162 posters will be presented. Six keynote lectures, two Special Sessions, a Special Poster Corner and a Prize Ceremony complete the program. 

Last date to register for the conference is June 25th, because of the overwhelming number of conference participants the gala dinner is fully booked.

Reasons to attend EUROoCS 2022:

  • Share your research results during the oral or poster sessions
  • Learn about the latest developments in the Organ-on-Chip field
  • Meet the keynote speakers and other expert researchers
  • Join the Special Sessions of the EUROoCS Regulatory and Industrial Advisory Boards: ‘Standardization and Qualification’ and ‘Company Challenges’
  • Connect with the National Organ-on-Chip Communities in the Special Poster Corner
  • Benefit from ample networking / collaboration opportunities during the coffee breaks, lunches and social event at La Bastille

Be a Winner:    

  • Three Best Oral Presentation Awards
  • Six Best Poster Presentation Awards
  • Two Travel Awards for EUROoCS 2023
  • Ten Next Generation Travel Awards for EUROoCS 2022

Read more on the annual meeting page