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The Law and Economics of Regulation of Engineered Living Materials in the EU: Prospects for Investments and Innovation

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Engineered Living Materials Portfolio year 3 progress report (2025) and year 4 plans (2026):  READ MORE

Discover the progress made by the EIC ELMs Portfolio in advancing living materials technology and shaping Europe’s leadership in this field. This report highlights key achievements since the 2023 strategic plan and outlines the objectives for the fourth year of the Portfolio.

Original link of the dokument.  

EMA Horizon Scanning Report on ELMs in collaboration with EIC (2025):  ​  READ MORE

Discover how ELM’s portfolio contributed to the EU-IN Horizon Scanning Report “Engineered living materials for in situ production of therapeutics”

Original link of the dokument.  

EIC-EMA Workshop on the Regulatory Framework of ELMs (2025)  READ MORE

On February 6, 2025, we were thrilled to see several pioneering projects from the EIC ELMs Portfolio—PRISM-LT, -LoopOfFun-ELMs, NextSkins, Bio-HhOST, BioRobot-MiniHeart, ISOS Project EU, Bioaction EU, REMEDY —participate in the EIC-EMA Workshop on the Regulatory Framework of Engineered Living Materials (ELMs).

Co-organized by the European Innovation Council (EIC) and the European Medicines Agency (EMA), this workshop served as a vibrant exchange platform for ELM researchers to explore regulatory challenges. These innovative materials are set to transform medicine and biotechnology, marking a critical milestone for ELMs in Europe.

With keynotes from Barbara Gerratana (EIC), Orsolya Symmons (EIC), and @Costantinos Ziogas (EMA), the event ignited insightful discussions. The panel, co-moderated by Falk Ehmann (EMA) and Laura Martinelli (PRISM-LT, INsociety), delved into essential topics like:
 
  - ELM product classification and approval pathways
  - Safety and compliance requirements
  - Clinical trials for bioprinted and engineered tissues
  - EMA’s guidance on ATMPs

This interactive session encouraged a plethora of questions and underscored the imperative for ongoing regulatory dialogue as ELM technologies continue to evolve. The workshop provided valuable insights into the changing regulatory landscape, highlighting the necessity for continuous collaboration among innovators, regulatory bodies, and industry stakeholders.

Portfolio Public Feedback on the Advanced Material Act (2025):  ​  READ MORE

Discover how ELM’s portfolio contributed to the European Commission’s Call for Evidence supporting the upcoming Advanced Materials Act, which aims to reinforce Europe’s open strategic autonomy, reduce dependencies on critical resources, and boost EU competitiveness.

Original link of the dokument.     

Engineered Living Materials Portfolio year 2 progress report (2024) and year 3 plans (2025):   READ MORE

Discover the progress made by the EIC ELMs Portfolio in advancing living materials technology and shaping Europe’s leadership in this field. This report highlights key achievements since the 2023 strategic plan and outlines the objectives for the third year of the Portfolio.

Original link of the dokument.  

 Engineered Living Materials Portfolio Strategic Plan (2023):   READ MORE

Discover the objectives and the activities to reach those objectives of the EIC ELMs Portfolio in advancing living materials technology and shaping Europe’s leadership in this field. This strategic plan is a living document. Future updates can be found in the yearly progress reports of the EIC ELMs Portfolio.

Original link of the dokument.  

LIST OF PORTFOLIO PROJECTS

WEBSITE

Bacteria Biofilm as bio-factory for tissue regeneration

Coordinator: ​CNR (IT)

Project partners : 7 

Key-words: ​bio-hydrogels, bactoinfection, liposome, phages, hard tissue regeneration, processing technologies

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BIOACTION aims at developing a new methodology in implant technology based on functionalized bio-hydrogels that will convert the negative occurrence of biofilm-associated infections, the primary cause of implant infections and failure, into a positive resource. The main goal of BIOACTION is to transform implant-associated bacteria for the programmable production of specific proteins for in vivo cell recruitment and tissue regeneration, exploiting gene sequences loaded on engineered liposomes and phages, bound to hydrogel scaffolds. BIOACTION will develop new biomimetic substrates that can transform biofilm into extracellular matrix for the regeneration of target tissues. It will establish a high versatile technology to be used as injectable materials and implant coatings for periodontal and peri-implant infection treatments. The proposed approach will be validated in two clinically relevant animal models: dental implant and permanent transcutaneous bone. BIOACTION, would radically advance the future of infection treatment by revolutionizing the classical approaches leading to the improvement of state of care, health outcomes and to achieve huge socio-economic benefits. The project is strongly interdisciplinary in nature involving expertise biomaterials, synthetic biology, phage and liposome technology, medicine.

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Next Generation 3D Tissue Models: Bio-Hybrid Hierarchical Organoid-Synthetic Tissues (Bio-HhOST) Comprised of Live and Artificial Cells.

Coordinator : University of Trento, Italy

Project partners : 7 

Key-words : synthetic biology, artificial cells, 3D bioprinting, microfluidics, 3D cell culture

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Bio-hybrid materials and physiochemical interactions hold great promise for advancing the pharmaceutical and chemical sectors. However, current developments in these technologies are limited, with few functional options available. In this context, the EIC-funded Bio-HhOST project aims to develop a bio-hybrid material composed of living and artificial cells, enabling a wide range of interactions. The incorporation of artificial cells will facilitate the proliferation, function, and differentiation of living cells, while also possessing functional metabolisms capable of revolutionising the sector through chemical interactions. Additionally, the project employs 3D tissue models and simulations to enhance the understanding of the material and its response to diseases, thereby reducing the necessity for animal research.

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Engineering a swimming bio-robot and a living human mini-heart

Coordinator: University of Twente (NL) 

Project partners : 4 

Key-words: tissue engineering, b​iosensing, stem cells, cardiovascular diseases, physiology 

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Manufacturing our very own hearts is just a heartbeat away, literally. Engineers are joining forces with biologists to make biological heart robots. The EU-funded BioRobot-MiniHeart project is developing a vascularised beating mini-heart. In parallel, the team is designing a self-propulsion swimming bio-robot created by assembling human cardiac cells into 3D tissue structures; using sacrificial moulding and high-resolution 3D bioprinting. The mini-heart and the bio-robot will provide scientists with a more realistic human cardiac model in vitro and an appropriate tool to assess cardiotoxicants’ presence in the environment. We expect this innovation to help speed up the development of heart disease cures.

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Combining fungi and bacteria into novel bi​omaterials

Coordinator: ​​Royal Danish Academy – Architecture, Design, Conservation (DK) 

Project partners : 6 

Key-words: ​bacteriology, synthetic biology, mycology

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Engineered living materials (ELMs) are composed of living cells endowed with unique properties and functions. ELMs have received significant attention in materials sciences due to their tuneability and potential for sustainable production. Funded by the European Innovation Council, the Fungateria project aims to generate an innovative portfolio of ELMs that combine fungi with bacteria. 

Growing the vegetative part of the mushroom—the mycelium—on different organic substrates is the most common way of producing fungi-based materials. The project will combine the mycelium with bacteria that serve as a chassis for sensor-containing genetic circuits. The resultant ELMs will exhibit advanced functionalities and inducible degradation when no longer needed.

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Implantable Ecosystems of Genetically Modified Bacteria for the Personalized Treatment of Patients with Chronic Diseases

Coordinator: ​​​SILK BIOMED S.L.

Project partners : 6 

Key-words: GEB, ELM, silk fibroin, micro bioreactor, chronic diseases, aged-related macular degeneration

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ISOS is pioneering the development of a groundbreaking biomedical solution: a bioreactor housing genetically engineered probiotic bacteria (GEB) within biomaterials. This innovation is aimed at chronic diseases requiring extended treatments. Encapsulated GEB populations synthesize therapeutic molecules in response to patient-specific signals such as inflammation or reactive oxygen species. Designed to maintain dynamic equilibrium and ensure GEB survival within the pathological environment, ISOS offers personalized treatment through in-silico tools and synthetic biology. As a Proof-of-Concept, ISOS plans to deploy an implantable GEB-based bioreactor for treating wet age-related macular degeneration (wAMD). This advancement aims to replace frequent Anti-VEGF injections with a single bioreactor, enhancing therapeutic efficacy and minimizing side effects. ISOS pioneers a new therapeutic approach using recombinant probiotic libraries, promising precise local drug production and efficient delivery tied to dynamic pathological cues.

WEBSITE

Fungi-based engineered living materials with controllable properties

Coordinator: ​​​​​​Albert-Ludwigs-Universitaet Freiburg (ALU-FR) (DE) until 30.06.2023. From 01.07.2023 Leibniz-Institut fuer neue Materialien gemeinnutzige GmbH (INM) (DE) is the coordinator because of the switch of the PI and his team from ALU-FR to INM  

Project partners : 5

Key-words: ​​mycology, electrical engineering, sensors

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Fungi comprise approximately 100 000 described species to date. The real total is estimated to be in the millions. They are amazing factories, producing numerous bioactive metabolites of therapeutic interest. The EU-funded LoopOfFun project has recognised their potential in yet another innovative area – as part of engineered living materials (ELMs), with open- and closed-loop control of mechanical and structural properties. The project will identify fungi gifted with superior abilities for materials synthesis and harness them for synthetic biology-based programming. The programming will be accomplished via a novel automatic robotised platform to develop the fungi into ELMs based on iterative design-build-test-learn cycles. The outcomes will then support the rational design of such materials.

website

Living therapeutic and regenerative materials with specialised advanced layers

Coordinator: ​​​​Delft University of Technology (NL) 

Project partners : 3

Key-words: ​bacteriology, synthetic biology, mycology

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Compared to conventional materials, biomaterials in living organisms possess specific architecture and organisation: and often exhibit multiple functions. Εngineered living materials (ELMs) have emerged at the junction of synthetic biology and material science to produce materials with improved functionality because of the living organisms within them. 

Funded by the European Innovation Council, the NextSkins project is inspired by the structure and function of the many layers of skin. Researchers will mimic the specialised skin arrangement to make two engineered living materials: one with a therapeutic role to treat skin diseases and one with a purpose to be used as a protective garment in sports.

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Living tissue manufacturing using symbiotic materials

Coordinator: IN society (IT)

Project partners : 6

Key-words: ​bacteriology, stem cells, bioprinting

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The EU-funded PRISM-LT project will use a hybrid living materials concept to create a flexible platform for living tissue manufacturing. The innovative bio-ink will contain stem cells integrated into a supporting matrix with engineered helper bacteria or yeast cells. The bioprinting process will produce a 3D patterned structure where stem cells could be induced to differentiate into different lineages. The directed stimulation of differentiating stem cells will force them to produce lineage-specific metabolites for sensing by the designer helper cells. The helper cells within the platform will then enhance localised lineage commitment to sustain differentiation stability. The project aims to implement this strategy for the development of two symbiotic materials designed for biomedical and food applications, respectively.

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Archibiome tattoo for resistant, responsive, and resilient cities

Coordinator: InnoRenew CoE (SI)

Project partners : 6

Key-words: ​​​microbiology, architecture, biofabrication, microbiome

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The REMEDY project pioneers the archibiome tattoo - a living, bespoke layer for buildings that enhances both, aesthetics and functionality. By integrating advances in microbiology, synthetic biology, and materials science, REMEDY develops engineered living materials and specialized biofabrication process for personalized architectural design. At the core of REMEDY’s approach are tailored microbial consortia formulated into innovative microbial inks that function like probiotic skincare. These living consortia establish a resilient microbiome on building surfaces, providing pathogen protection, supporting carbon sequestration, producing oxygen, and enabling bioremediation. Funded by the European Innovation Council, REMEDY brings metabolic thinking into sustainable design, advances probiotic architecture, and drives a microbial revolution to reshape the perception of microorganisms in the built environment.

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Supervised morphogenesis in gastruloids as an alternative to conventional single-tissue organoids

Coordinator: Oslo University Hospital (NO)

Project partners : 7

Key-words: ​​​​artificial intelligence, developmental biology, stem cells, physiology

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The lack of realistic in vitro organ models that faithfully represent in vivo physiological processes is a major obstacle affecting the biological and medical sciences. The current gold standard is animal experimentation, but it is increasingly evident that these models mostly fail to recapitulate human physiology. Moreover, animal experiments are controversial, and it is a common goal in the scientific community to minimise the use of animals to a strictly necessary minimum. 

The emergence of stem cell-engineered organ models called organoids represents the only viable alternative to animal research. However, current organoid technology is yet to produce the larger physiologically relevant organ models that the medical sciences need. Specifically, current organoids are too small, not vascularised and lack the 3-dimensional organisation found in vivo. 

In this interdisciplinary project, we aim to challenge all these limitations using the recently developed gastruloid technology guided by cutting-edge bioengineering and artificial intelligence. 

Gastruloids are formed by initiating the very early developmental processes and develop along a highly coordinated three-axial process that closely resembles mammalian embryogenesis. They can establish several organ precursors simultaneously, thus constituting relevant improvements over conventional single-tissue organoids. 

To harvest the potential of gastruloid technology, we will first implement extensive sequencing and imaging experiments to optimise the developmental trajectory of gastruloids for organ inductions. We will then build these datasets into a multimodal data matrix to identify gastruloid candidates for cardiovascular and foregut development. Candidates with substantial vasculogenesis will be chosen for later vascularisation by anastomose with endothelial cells.”

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