Currently, there are no effective drugs available to fight SARS coronavirus-2 (SARS-CoV-2) and the associated disease, COVID-19. The working group on High-Throughput Drug and Target Discovery at Fraunhofer ITEM in Regensburg is cooperating with partners from the University of Regensburg and the company 2bind GmbH, aiming to identify drug candidates that specifically inhibit packaging of the SARS-CoV-2 genome into virus particles and thereby prevent replication of the virus. The project will be funded by the Bavarian Research Foundation for a period of one year, starting in December 2020.
Read the news of December 16, 2020: Fraunhofer relies on automation technologies in medical research
Our Contact: Dr. Kamran Honarnejad
Scientists assumed for quite some time that the coronavirus is transmitted primarily by droplet infection – that is, through larger droplets and particles. There are, however, findings clearly suggesting that tiny exhaled droplets which are smaller than 10 µm in diameter and remain airborne for a long time – referred to as aerosols – may cause infections, if they are loaded with viruses. In the project AVATOR (Anti-Virus-Aerosol: Testing, Operation, Reduction), scientists are, therefore, investigating how to monitor and reduce the risk of infection from aerosol-borne virus in indoor areas. In addition to simulation-based methods for air dispersion assessment, the project is also aimed at developing air purification technologies involving both trapping and inactivation of the virus. This will serve as a basis for deriving hygiene concepts for different applications. The results of this project will be beneficial to all operators of indoor spaces – in particular means of transport such as airplanes or trains as well as production facilities and meeting rooms, but also classrooms and open-plan offices shall be addressed.
Project partners: Fraunhofer IBP, Fraunhofer EMI, Fraunhofer ITWM, Fraunhofer ICT, Fraunhofer LBF, Fraunhofer IAP, Fraunhofer IMM, Fraunhofer IFF, Fraunhofer IPM, Fraunhofer IGD, Fraunhofer IFAM, Fraunhofer IGB
Our Contact: Dr. Annette Bitsch
The present SARS-coronavirus-2 pandemic with all its effects on society – both health and economic – highlights the urgency of developing new therapies for COVID-19 treatment. At the same time, it demonstrates the necessity to become well prepared for new virus infections we may be facing in the future. To help control the current pandemic and brace for novel pathogens that may cause future pandemics, Fraunhofer researchers have initiated the project BEAT-COVID to develop independent novel therapy strategies and build up platform technologies that will enable rapid and targeted development of new drugs against as yet unknown pathogens that may emerge. Based on their expertise in preclinical and clinical drug development, five Fraunhofer Institutes and cooperating universities, coordinated by Fraunhofer ITEM, want to address the following objectives: prevent the virus from entering host cells, combat the virus itself, and control the excessive immune response triggered by the virus.
Read the press release of October 19, 2020: BEAT-COVID – advanced therapy strategies against the pandemic
Project partners: Fraunhofer IZI, Fraunhofer ISC, Fraunhofer IAP, Fraunhofer IZM
Our Contact: Prof. Jens Hohlfeld
As a pioneer in applied research, the Fraunhofer-Gesellschaft is bringing together the expertise of 23 Fraunhofer institutions to develop new development and production technologies for innovative cell and gene therapeutics, as well as vaccines, in the “Production for Intelligent Medicine” innovation cluster.
The most recent case of the COVID19 pandemic once again has shown the tremendous challenges which arise in the context of the development and subsequent production of specific vaccines to respond to novel health risks. To help contain the pandemic, researchers of the Fraunhofer ITEM division of Pharmaceutical Biotechnology have designed a completely new production strategy for a coronavirus vaccine, which shortens the process development time for the production of investigational medicinal products for clinical trials down to a few months – in contrast to the usual 1.5 to 2 years.
In addition, Fraunhofer ITEM is bringing in its comprehensive know-how on the biology, production, and differentiation of stem cells and on lung macrophages. Within this project, quality characteristics and risk profiles will be developed for these cell types and then be used as a basis for automated production processes.
Read the news of August 18, 2020: Fraunhofer relies on automation technologies in medical research
Project partners: 23 Fraunhofer institutes
Our contact: Prof. Dr. Holger Ziehr
In the face of the pandemic spread of SARS-CoV-2 there is an urgent need for effective drugs and vaccines. To speed up the process, existing drugs that have already been approved for treatment of other conditions are tested for their efficacy against the new coronavirus. Scientists of the German Primate Center (DPZ) in Göttingen, Germany, and the Fraunhofer ITEM are now receiving 1.6 million euros from the German Federal Ministry of Education and Research (BMBF) for a collaborative project investigating the efficacy of nafamostat.
Read the press release of July 31, 2020: Pancreas drug nafamostat an option for COVID-19 treatment?
Project partner: German Primate Center
Our contact: Prof. Dr. Armin Braun
The current global health emergency caused by the SARS-CoV-2 pandemic poses an urgent need for vaccines and drugs to prevent infections and manage COVID-19. By drug repurposing, i.e. by using existing active agents with known safety profiles or drugs approved already for treating other diseases or conditions for new therapeutic purposes, Fraunhofer scientists are aiming to quickly identify drugs and develop therapies for COVID-19 treatment. This approach is used in the DRECOR project, addressing above all the following goals: First of all, the scientists want to identify suitable candidate molecules targeting the lungs and airways and formulate these for inhaled or systemic administration. For inhaled administration of these drugs, a prototype of a smart medical device for use in clinical trials will be created in addition. Furthermore, the team will set up complex in-vitro models and test systems that will also be available for use in other projects targeting different therapeutic areas. In the long run, DRECOR is aimed at establishing a multidisciplinary drug formulation and delivery network and process, so as to be better prepared for future pandemics. Seven Fraunhofer Institutes are collaborating in the DRECOR project, coordinated by Fraunhofer IME.
Project partners: Fraunhofer IME, Fraunhofer IGB, Fraunhofer ISC, Fraunhofer IBMT, Fraunhofer IAP, Fraunhofer IZI, Fraunhofer Project Center for Drug Discovery and Delivery at Hebrew University of Jerusalem (Israel)
According to the current state of knowledge, SARS-CoV-2 viruses and many other pathogens are transmitted primarily by droplet infection. To reduce the risk of infection, a broad range of legal and voluntary measures have been implemented, for example social distancing and the wearing of face masks. An issue of constant debate is the transmission of viruses through exhaled aerosols – tiny (< 5 µm) liquid droplets that remain suspended in the air for a long time. Fraunhofer ITEM experts now intend to use existing, appropriate measurement techniques to systematically investigate the proportion of fine aerosol particles in exhaled air and whether the face masks currently in use provide efficient protection against exhaled aerosols. The researchers hope that their results will contribute to a better understanding of coronavirus transmission and will help to better assess the relevance, suitability and prioritization of corresponding protective measures, in particular in the health and geriatric care sectors. In addition, they aim to evaluate the efficiency of passive protective measures, such as ventilation of indoor areas.
Our contact: Dr. Katharina Schwarz
Research on SARS-CoV-2 and efficacy testing of candidate drugs against this virus using lung infection models with the active virus can be performed only in safety level 3 (S3) laboratories. Not all research institutions, however, have access to S3 laboratories, and working under S3 conditions is very challenging. In this project, virus-like particles will be used for a SARS-CoV-2 infection model that will allow work in this context to be performed at the lower safety level 2. For efficacy testing of drug candidates that might be used for COVID-19 treatment, the Fraunhofer ITEM scientists want to use tissue slices from human lung explants, also referred to as precision-cut lung slices (PCLS). These slices remain viable for several days in ex-vivo cultures and perfectly mimic the natural responses of the lung. To allow the tests to be performed under S2 conditions, the scientists will use virus-like particles (VLPs), which are non-infectious. VLPs are virus particles that have the spike protein of SARS-CoV-2 on their surface and are thus able to enter the host cell, however, they are unable to replicate in the cell and therefore cannot produce infectious virus particles. Using VLPs, the initial SARS-CoV-2 infection can be mimicked under S2 conditions in in-vitro and ex-vivo models, such as human precision-cut lung slices (PCLS). This model will be used to test drug candidates for COVID-19 treatment and also to study risk factors for severe courses of COVID-19 in vulnerable patient groups.
Our contact: Dr. Sabine Wronski
Patients experiencing a severe course of COVID-19 often require ventilation, some of them with a non-invasive method, others in an intensive care unit. In either case, the patient's lung function and respiratory parameters have to be monitored. Patients and also the health-care staff should be provided with the best possible protection from a viral infection. An intelligent viral filter for use with both non-invasive and invasive ventilation is aimed at enabling this high level of protection. In the project Filter4Flow, Fraunhofer scientists are collaborating with the companies Aircontrols, ELK and Christoph Manegold MT-Consult to develop such a smart viral filter – a novel combination of fast sensor elements for measuring the flow rate, pressure and inhaled gas and a viral filter. The signals are digitized and transmitted quickly and wirelessly to a ventilation or patient monitoring system (e.g. an app). The intelligent viral filter allows precise, reliable and at the same time cost-effective breath monitoring in numerous patients, while also providing a filter function that protects both patients and staff from infection. This can help prevent the dreaded shortage of ventilation resources.
Project partners: Fraunhofer IST, Fraunhofer IIS, Aircontrols, ELK, Christoph Manegold MT-Consult
Our contact: Dr. Gerhard Pohlmann
Tiny droplets, also referred to as aerosols, in the exhaled breath of infected individuals are considered the main vector spreading the coronavirus SARS-CoV-2. In the project CoClean-up, we are assisting Fraunhofer IKTS in developing a system for purification of the air extracted from enclosed indoor spaces. The system is based on electrochemical total oxidation, a technology allowing complete elimination of organic substance. This treatment also makes sure that no endotoxins or other substances resulting from incomplete degradation of airborne pollutants can get into the indoor air, in particular in ventilated or air-conditioned indoor areas. After successful development of a prototype, the scientists intend to rapidly proceed with system optimization and integration as well as scale-up, and pursue the launch into the market. This highly efficient indoor air disinfection technology shall also be used in the future to prevent viruses from spreading.
Project partner: Fraunhofer Institute for Ceramic Technologies and Systems IKTS
Our contact: Dr. Katharina Schwarz
There are different therapeutic targets for SARS-CoV-2 infection. One approach is to prevent the virus from entering host cells. This is the development concept Fraunhofer ITEM and Helmholtz-Zentrum Dresden-Rossendorf as a partner are pursuing in the project Immunovid‐19. The partners have joined forces to develop a therapeutic approach aiming to prevent the coronavirus SARS-CoV-2 from entering cells by means of a fusion protein, using the soluble form of the ACE2 protein. The scientists are currently developing a recombinant CHO production cell line for manufacturing of the fusion protein.
Project partner: Helmholtz-Zentrum Dresden-Rossendorf
Our contact: Dr. Corinna Lüer
Before a new vaccine reaches the stage of clinical application, it has to go through defined development phases in line with regulatory and process-related technical requirements. Using a passive vaccine against SARS-CoV-2 as an example, the project partners are closely collaborating with Paul-Ehrlich-Institut to develop an approach aimed at drastically reducing the time required for bioprocess development and first GMP manufacturing of an investigational medicinal product for clinical trials – from previously more than 15 months to less than 6 months. This requires the partners to rethink both quality and regulatory aspects. The key element is an abridged bioprocessing and regulatory setup which, if it proves feasible and can be validated, would quickly provide access to a therapeutic solution – without compromising patient safety in any way. Should this regulatory-technical shortcut turn out to be successful, the principle could generally be used for the development of new biopharmaceuticals, thereby accelerating their translation from bench to bedside. In future pandemics, this would enable faster development of new vaccines.
Read the press release of November 18, 2020: Human antibody against COVID-19 ready for clinical trials
Project partners: CORAT Therapeutics, Paul-Ehrlich-Institut
Our contact: Prof. Dr. Holger Ziehr
Monoclonal antibodies, which can be harvested for example from the immune plasma of recovered COVID-19 patients and are able to inactivate the virus (neutralizing antibodies) are considered promising drug candidates. In a special lung model, Fraunhofer ITEM scientists want to study the safety and pharmacokinetics (i.e. the whole range of processes a drug undergoes in the body: absorption, distribution in the body, biochemical processing, and elimination) of a monoclonal antibody. The model they use for this is the isolated perfused rat lung (IPL). In this ex-vivo organ model, they are investigating the safety, bioavailability and kinetics of intravenously administered antibodies. In addition, they want to elucidate whether intravenously administered antibodies are actually delivered to the site of action of a SARS-CoV-2 infection, which is the lung, or whether inhaled administration is the more promising route.
Our contact: Dr. Christina Hesse