Press releases

How can chemicals be assessed safely in the future while reducing animal testing and maintaining a high level of scientific confidence? The European research community is working hard to bring about this transformation. One major step toward regulatory implementation is the European Commission’s new roadmap for the gradual phase-out of animal testing in the safety assessment of chemicals. The Fraunhofer Institute for Toxicology and Experimental Medicine ITEM is actively helping to drive this development, not least through the development of the ASPA workflow within the EU-funded project RISK-HUNT3R.

Air pollution remains the leading environmental cause of premature death in the European Union, while occupational exposure to hazardous airborne substances continues to pose serious risks to workers in industrial settings. Despite existing regulation, industries still need more effective tools to monitor emissions, reduce exposure and manage risks in real time.

Hair products used in hair salons release aerosols that can cause respiratory tract irritation if inhaled. Under a contract from industry, researchers at the Fraunhofer Institute for Toxicology and Experimental Medicine ITEM investigated the effects of aerosols produced when using heated chemical hair products. Using an innovative cell-based in vitro inhalation method, the researchers can estimate effects on the respiratory tract and identify potentially harmful substances. This non-animal testing method supports safe product development that is fully in line with the safe-by-design approach, which integrates safety in product development right from the start.

Innovative mRNA-based therapeutics and vaccines offer hope in the fight against cancer, genetic disorders and infections. However, their development and production are complex, slow and difficult to scale. Seven Fraunhofer institutes are working to change this situation. In the RNAuto project, they have now developed an automated, digitally controlled production system that is fast, flexible and cost-effective.

The Fraunhofer Institute for Toxicology and Experimental Medicine ITEM has completed the sale of its Braunschweig location to AveThera GmbH. Through this acquisition, the Braunschweig location will now be taken over by a young company that plans to use the location's expertise and infrastructure to develop innovative solutions.

Thursday, March 12, is the big day: A research rocket from the REXUS program launched into the stratosphere from the Esrange Space Center in Sweden, carrying the THRIVE module with components of the cell-based StellarHeal wound care material from Würzburg, Hanover, and Dresden. Preparations for the current rocket launch have been underway since last November, and now it's time to keep our fingers crossed that the experiments yield good results.

As of January 1, 2026, the management of the GLP Test Facility at the Fraunhofer Institute for Toxicology and Experimental Medicine ITEM has changed. Prof. Dr. Armin Braun, Head of the Department of Preclinical Pharmacology and Toxicology, has been appointed Head of the GLP Test Facility. He succeeds Prof. Dr. Norbert Krug, Director of Fraunhofer ITEM, who previously held this responsibility. Dr. Sylvia Escher, Head of the Department of Safety Assessment and Toxicology, has been appointed Deputy Head of the GLP Test Facility.

The collaborative project “iGUARD – Inhalable RNA Therapeutics for Targeted Treatment of Lung Diseases” has been honored with the Lower Saxony Innovation Award 2025. The team of researchers from Hannover Medical School (MHH) and the Fraunhofer Institute for Toxicology and Experimental Medicine ITEM received the award in the category “Knowledge and Technology Transfer.” The prize was presented on November 4, 2025, at a formal ceremony in Hannover by Falko Mohrs, Lower Saxony’s Minister for Science and Culture.

The Fraunhofer Institute for Toxicology and Experimental Medicine ITEM has now been officially accredited by AAALAC International (Association for Assessment and Accreditation of Laboratory Animal Care International). This underlines the institute’s commitment to a responsible, ethical, and humane use of animals in research – going beyond legal requirements.

Approximately five million people worldwide suffer from chronic inflammatory bowel diseases (IBD), including Crohn's disease and ulcerative colitis. Despite modern therapies, many immunological mechanisms underlying the disease remain poorly understood – posing a key challenge for the development of new targeted treatments.

Fraunhofer ITEM has been officially included in the list of so-called Article 36 organizations – an important step for our role in the European research landscape for food safety.

How many birch pollen particles in the air trigger symptoms in individuals with allergies? A recent study published in the journal International Archives of Allergy and Immunology provides an answer: allergic symptoms occur at concentrations of 50 - 100 pollen per cubic meter of air.

Targeted nerve stimulation instead of drugs: With the kick-off of the PREPARE project DUSTIN, a promising research alliance for the visionary treatment of autoimmune diseases is starting its work. Four Fraunhofer Institutes are pooling their expertise to develop a miniaturized, battery-free implant that communicates and is powered by ultrasound. The project is receiving €3.5 million in funding.

The Pharmaceutical Biotechnology division at the Braunschweig location of the Fraunhofer Institute for Toxicology and Experimental Medicine ITEM, one of the institute’s five research divisions at three different locations, is to be closed as of February 28, 2026. The research division has been operating at an ongoing deficit, with little likelihood of this changing in the future. The executive board of the Fraunhofer-Gesellschaft has now approved the request to this effect made by the institute management. One possible solution for maintaining the Braunschweig location remains – the transfer to a private company.

A research team from the Fraunhofer Institute for Toxicology and Experimental Medicine ITEM has, for the first time, demonstrated that drug concentrations in the human lung can be measured directly via particles in exhaled breath – a breakthrough with major implications for the targeted development and optimization of inhaled therapies. For this groundbreaking study, Prof. Dr. Jens Hohlfeld, Head of Airway Research at Fraunhofer ITEM, together with Dr. Olaf Holz, received the prestigious Willi Stahlhofen Award from the International Society for Aerosols in Medicine (ISAM). The award ceremony took place on June 24 at the ISAM Congress in Washington DC, USA.

Dr. Steinacher completed her doctoral studies with a dissertation conducted in collaboration between MHH, Fraunhofer ITEM, and F. Hoffmann-La Roche AG in Basel. The work was supervised by Dr. Lauriane Cabon (Roche) and Prof. Dr. Armin Braun (Fraunhofer ITEM). She was awarded one of the two doctoral prizes of the Society of Friends of MHH e.V., each worth €2,500.

What drives the metastasis of melanomas right from the very beginning – long before it becomes clinically detectable? This is the question the research teams addressed in their publication in Nature Cancer.

Traditional storage solutions are reaching their limits in light of the steadily in-creasing volume of data generated worldwide. In the BIOSYNTH project, three Fraunhofer institutes are developing a microchip platform for future mass data storage using synthetic DNA. In this interview, Dr. Uwe Vogel, the project’s co-ordinator and head of the Microdisplays and Sensors department at the Fraun-hofer Institute for Photonic Microsystems IPMS, explains how the researchers plan to widen the use of this high throughput-capable, modular system for synthesizing DNA, RNA and peptides to also include biological applications such as screening for harmful substances and development of active ingredi-ents.

The development of novel therapeutics offer great hope for the fight against widespread diseases such as cancer, but they can impair the cardiovascular system, so development often fails early on. Researchers from the Fraunhofer Institute for Toxicology and Experimental Medicine ITEM and Hannover Medical School have developed a complex cardiac organoid model that can be used to study the potential cardiotoxicity of new medications. Their miniature heart even has an immune system of its own.

As part of the portfolio conference held by the Institute for Biomedical Translation (IBT) on November 27, 2024, a distinguished jury selected Inhale+ to receive €1.3 million in funding. We are immensely proud that this groundbreaking technology, developed at Fraunhofer ITEM, now reaches patients.

In July 2024, the Technical Rule for Hazardous Substances 529 (TRGS 529) was revised. TRGS 529 applies to all activities related to the production of biogas as well as the operation of biogas plants. It also regulates the handling of additives and auxiliary materials, including special safety measures required when using cobalt and nickel, as both heavy metals are considered carcinogenic.

Electronic cigarettes, or vapes, are commonly viewed as less harmful to people’s health than tobacco cigarettes. And yet, they are not without health drawbacks. For many ingredients, it is unknown how they will behave when heated. Since the temperatures inside e-cigarettes vary widely, different products can be released during thermal decomposition. This makes it more difficult to gauge the potential risks of these tobacco alternatives. Until now, there has been no testing system that could be used to test the ingredients used across the entire relevant temperature range. Now, with EVape, the Fraunhofer Institute for Toxicology and Experimental Medicine ITEM has developed a prototype device for controlled vaporization of e-liquids in a broad temperature range. The emissions released during the process can then be analyzed and subjected to a toxicological assessment. The findings are generally valid, regardless of which e-cigarette the liquid is used in.

Initiation of Phase Ia/Ib1 with the first human administration of the intranasal form of OM-85, a bacterial lysate and immune system modulator, already approved in oral form for the prevention of recurrent respiratory tract infections. Trial aims to deepen and understanding of OM-85-Intranasal (IN) and explore its potential impact on asthma management when administered as a nasal spray. (Geneva) OM Pharma, a global Geneva-based biotech and leader in bacterial lysate products, in collaboration with Fraunhofer Institute for Toxicology and Experimental Medicine ITEM announce the dosing of the first participant in a Phase Ia/Ib clinical trial evaluating the safety and tolerability of OM-85-Intranasal (IN) in 27 healthy volunteers during Phase Ia and 14 patients with mild asthma during Phase Ib.

The BIOSYNTH project is funded by the Fraunhofer-Gesellschaft and aims to develop a new microchip platform that enables efficient and digitally controllable cell-free biosynthesis. The Fraunhofer Institute for Photonic Microsystems IPMS leads the consortium and collaborates with the Fraunhofer Institute for Toxicology and Experimental Medicine ITEM and the Fraunhofer Institute for Cell Therapy and Immunology, part of Bioanalytics and Bioprocesses IZI-BB, on technologies that can be used in the future for mass data storage with very high storage density or in pollutant screening in human toxicology.

Every year, around half a million people in Germany are diagnosed with cancer. Despite the existence of effective treatment options for many types of cancer, many questions about the development of the disease remain unanswered. Why does a tumor develop? What factors promote the growth of cancer cells? Why do metastases spread to other organs over time? The animal models mainly in use to date only represent the actual processes in the human body to a limited extent. The Fraunhofer Institute for Material and Beam Technology IWS in Dresden has developed special microsystems in collaboration with the Fraunhofer Institute for Toxicology and Experimental Medicine ITEM in Hanover and the University of Regensburg. They are now using them to examine tissue sections of tumors under realistic conditions.

With the aim of developing a new technology for brain regeneration, the EU project REGENERAR kicks off on March 22, 2024. Fraunhofer ITEM is one of seven research partners, led by the University of Coimbra, seeking to create better therapies for patients with neurodegenerative diseases or stroke using this technology.

A research team from the Fraunhofer Institute for Toxicology and Experimental Medicine ITEM and the Hannover Medical School (MHH) have made significant progress in developing a new antiviral therapy. The drug, which is inhaled, uses RNAi to target and deactivate parainfluenza viruses before they multiply.

The European Chemicals Agency (ECHA) has contracted a consortium led by the Fraunhofer Institute for Toxicology and Experimental Medicine ITEM, coordinated together with Michabo Health Science and BASF Metabolome Solutions, to conduct scientific studies on the reliability and relevance of new approach methodologies (NAMs) as alternatives to animal studies and to promote the use of such methods in the future. The aim of the contract is to get additional NAMs accepted by regulatory authorities, focusing on OMICS technologies and toxicokinetics, and therewith further reduce the number of animal studies conducted as part of safety assessments for chemical substances. The contract will run for six years for a total value of 4.2 million euros in ECHA funding. Other partners include the department for experimental toxicology and ecology at BASF, the University of Birmingham, and the biotech companies BioClavis, and Novogene Europe.

After three years in his post, Professor Thomas Thum has left the Fraunhofer Institute for Toxicology and Experimental Medicine ITEM and has stepped down from his joint institute management role at his own request. Instead, he will now be refocusing his attention on his positions as director of the Institute of Molecular and Translational Therapeutic Strategies at the Hannover Medical School (MHH) and as managing director of MHH spin-off Cardior Pharmaceuticals GmbH.