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A regulatory exchange on diversity and standardisation of 3D mucosal models for vaccine development

27-28 June 2023

The second Inno4Vac Subtopic 3 (MERMAID) Regulatory stakeholder meeting- “A regulatory exchange on diversity and standardisation of 3-D mucosal models for vaccine development” was held in June 27-28 and hosted by the Paul-Ehrlich-Institut in Langen, Germany.

This 2-day meeting brought together over 50 people from 25 organisations, including Inno4Vac academic and industry partners, model developers with expertise in tissue structure and immunology, vaccine regulators from various agencies across Europe and members of industry and other consortiums with expertise in this field.

The goal of ST3 is to develop cell-based in vitro 3-D models able to accurately depict the in vivo conditions during mucosal infection and reliably predict mucosal immune protection so that we have a tool to help evaluate vaccine candidates or therapies in preclinical and clinical studies. The meeting fostered discussion between regulators, academics and industry as a means to reach a common understanding of the challenges and advantages of using such models in vaccine research.

Talks on human and pathogen diversity offered insights on how to accurately and reproducibly capture molecular and immunological events associated with pathogen colonisation, how to select appropriate challenge strains for diverse pathogens, and how to overcome the reproducibility hurdles associated with individual donors. Talks on the second day investigated strategies to identify parameters needing standardisation as well as ways from a regulatory perspective to improve reproducibility of cellular, microbiological and physical aspects of organ-on-chip and assay systems.

This workshop is one of several being held which will contribute to our regulatory roadmap – a publicly available document on how to transition 3D in vitro tissue culture models from academia to regulatory approval for non-clinical and clinical vaccine development studies.

Discover more on the MERMAID Subtopic 3 goals here:



Dr. Irina Meln (Project and Innovation Manager at the European Vaccine Initiative)

This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 101007799. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA ( This communication reflects the author´s view and neither IMI nor the European Union, EFPIA, or any Associated Partners are responsible for any use that may be made of the information contained herein.


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