BeCAT deals with the development and manufacture of Advanced Therapy Medicinal Products (ATMPs) of all three classes:
(1) Somatic cell therapeutics,
(2) gene therapeutics and
(3) biotechnological tissue preparations (tissue-engineering),
as well as combinations of different classes or combinations in connection with medical devices.
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The Berlin Center for Advanced Therapies (BeCAT) has set up interdisciplinary project teams to do justice to the complexity and play a visible role internationally. The teams are made up of scientists with medical, scientific, engineering and biotechnological backgrounds. This results in synergies for innovation, speed and quality of translational research, i.e. the fast and efficient transfer of preclinical research into clinical development.
The fields of Regenerative Medicine and Hematology/Oncology represent important and dynamic research focuses of the Charité, which are underpinned by a strategic appointment concept, targeted investments in infrastructure and a research program supported by the State of Berlin. The leading scientists and the staff of the BeCAT working groups are recruited from these fields. Consequently, the focus of the BeCAT projects is on Regenerative Medicine, Hematology and Oncology.
Healthcare Transformation Academy - an EIT Health Initiative
Well-known organizations from the fields of business, research, education and healthcare have formed a strategic network to improve healthcare in Europe, and to create a more resilient and dynamic European healthcare system.
One initiative of this network, with the participation of BeCAT, is the Healthcare Transformation Academy (HTA).
The HTA will train healthcare professionals in transformative skills such as innovation management, leadership development, and high-quality care, tailored to the needs of the learners. The program consists of various courses made up of different modules on the 5 concepts of High Value Care, Innovation Management, Leadership, Digital Transformation and Personalized Medicine. Each module consists of different components and can be composed according to the role and level of the individual.
In each case, the course content has been developed by the project partner of the initiative that has the highest level of relevant and specialized expertise in the respective area.
More detailed information can be found on the website of the Heathcare Transformation Academy .
EU project geneTIGA
The number of chronic diseases caused by adverse immune reactions is continuously increasing.
To date, this group of diseases affects over 10% of the global population. In addition to the high burden on the patients (chronicity, organ failure, early death, reduced quality of life), this results in great direct and indirect costs for society (EU: >100 billion €/year direct health care costs). While symptoms can be treated, there is currently no cure.
Therapies have limited efficacy. Many times, the disturbed immune balance cannot be restored sustainably.
The consortium behind the "geneTIGA" project is addressing this problem using the example of IgA nephropathy (IgAN), the most common immunological kidney disease (glomerulonephritis), which is also one of the most common causes of kidney failure.
The consortium is made up of 11 partners from 7 countries, representing industry, academia and patient advocacy groups. They are among the experts in preclinical and clinical ATMP therapies.Their common goal is to develop a safe and efficient cell therapy based on genome-edited T cells for the sustained control of IgA nephropathy.
The specifically targeted cell therapy approach is also suitable for other diseases, such as IgA myeloma and rheumatoid arthritis, and as a "blueprint" for diseases of other Ig classes (e.g. IgG4). In summary, the novel concept underlying the therapy provides a mode of immunosuppression for autoimmune diseases. The overall objective is a new "living drug" intended as a one-time treatment for IgAN and other IgA-associated diseases, to be tested for safety and efficacy in first-in-human (FIH) studies. In addition, geneTIGA provides technology toolboxes with commercialization options beyond the core project. The aim is to reduce risks and accelerate the development of next-generation gene and cell products in general.
The geneTIGA project, led by Professor Petra Reinke and Dr. Dimitrios Laurin Wagner, has been selected for funding under the call " Tools and technologies for a healthy society (2021) " of the EU Framework Program "Horizon Europe (HE)". The project started on 01.07.2022 and will be funded with a total of 5.7 million euros over a period of four years.
- Charité - Universitätsmedizin Berlin, Germany (coordinator).
- University Hospital Freiburg, Germany
- Technical University of Braunschweig, Germany
- Oslo University Hospital, Norway
- Aarhus University, Denmark
- University of Oxford, UK (associated partner with own funding)
- ETH Zurich, Switzerland (associated partner with own funding)
- TissUse GmbH, Germany
- CheckImmune, Germany
- Innovation Acta, Italy
- European Kidney Patients Association, Austria
Further information is available on the geneTIGA website.
EU project ReSHAPE
The EU project ReSHAPE, led by Professor Petra Reinke, was selected for funding under the call for proposals "Innovation platforms for advanced therapies of the future" of the EU Framework Program "Horizon 2020" from a total of 63 applications.
The project started on 01.01.2019 and will be funded with a total of 13 million Euros over a period of four years.
ReSHAPE stands for "Reshaping undesired Inflammation in callenged Tissue Homeostasis by Next-Generation regulatory T-cell approaches (Treg) - from Advanced Technology Developments to First-in-Human Trials (FIH)."
Based on the triple-T concept - transdisciplinarity, technology, translation - ReSHAPE's main objective is to modify the treatment of patients with undesired immunity/inflammation, who currently have limited curative treatment options, through the application of novel Treg approaches, overcoming the limitations of first-generation Treg products.
The adoptive transfer of Treg is a promising new therapeutic option. It is a potential game changer in health care, particularly in immune diseases, organ and hematopoietic stem cell transplants (HSC), and regenerative medicine, including gene therapy.
ReSHAPE partners are world leaders in academic and clinical research and industry: Charité - Universitätsmedizin Berlin (Germany); Medizinische Hochschule Hannover (Germany); Centre Hospitalier Universitaire de Nantes (France); The Chancellor, Masters and Scholars of the University of Oxford (United Kingdom); Naturwissenschaftliches und Medizinisches Institut an der Universität Tübingen (Germany); Cell Therapy Catapult Limited (United Kingdom); TissUse GmbH (Germany) and Innovation Acta S.R.L. (Italy).
Further information is available on the ReSHAPE website.
Development of an intelligent GMP capable process automation of mesenchymal stem cells (MSCs)
In the field of cell therapy, bioprocesses are still mainly carried out manually in open systems.
The aim of the project is to perform these processes automatically in a closed system and to digitize and record all the data generated in a central location in order to improve reproducibility, avoid cross-contamination, increase the number of therapies and ultimately reduce costs.
There are already systems that can automate one step of a bioprocess, but there is not yet a system that can automate the entire bioprocess.
In terms of digitization and process control, many systems can only be programmed to a limited extent or with a lot of effort, and they do not offer a solution to centrally capture all bioprocess data. Especially for complex bioprocesses with many steps and multiple devices, there is no cross-process management of data and documentation.
We plan to develop a system that addresses these shortcomings, where stem cells can be automatically extracted from human tissue, expanded, differentiated, matured, and prepared for shipment to hospitals.
The project focuses on creating a closed and fully automated system for cell therapy applications based on mesenchymal stem cells (MSCs).
The Investitionsbank Berlin, as the development bank of the state of Berlin, supports joint projects of companies and research institutions with the Program for the Promotion of Research, Innovation and Technologies (ProFIT).
Within the framework of this program, the above-mentioned project is being carried out in close cooperation between BeCAT and OSPIN GmbH. A non-repayable grant for project funding in the amount of up to € 390,979 has been approved.
The grant is provided from funds of the European Regional Development Fund (ERDF) and from state funds.
RESTORE – an EU-funded initiative as trailblazer
Advanced therapies break with the principles of classical medicine. They open completely new possibilities for the treatment of many previously incurable diseases. Based on the most modern methods of molecular biology, genetics and biomedicine, they are potential game changers in the healthcare sector.
The special feature of advanced therapies is the use of living preparations (cells, tissues), which are processed in complex and highly innovative manufacturing processes. Their novelty, complexity and great innovation potential pose major challenges to both developers and regulators, with the result that the development and application of advanced therapies is still at an early stage throughout Europe.
This is where the RESTORE initiative comes in.
The initiative, funded in the first year of its development by the European research program Horizon 2020 (€ 1 million), is coordinated by Professor Hans-Dieter Volk, a clinical immunologist, and his team at the BIH Center for Regenerative Therapies (BCRT) ) and the Berlin Center for Advanced Therapies (BeCAT) of the Charité - Universitätsmedizin Berlin and the Berlin Institute of Health (BIH).
Its goal is to bring advanced therapies into the clinical practice.
The strategies for achieving this goal are many. These include a large number of activities aimed at educating and training the various specialist groups in the field, but above all various initiatives that contribute to accelerated translation (translate research concepts to clinical application) and the marketing of advanced therapies in Europe.
Further information is available on the RESTORE website