Fraunhofer Institute for Production Technology IPTResearch projekt "RauPE"
In biomedicine, research into the development of (personalized) stem cell-based therapies has been ongoing for several years. The pharmaceutical industry places great importance on stem cell-based therapies, as they offer enormous potential for the treatment of degenerative diseases in which tissue is gradually degenerated, as well as for tumor diseases. However, large-scale production is required to make stem cell-based therapies available to many patients. The "RauPE - Robust automated production of therapeutic extracellular vesicles" project therefore aims to develop a platform for the expansion of the cost-effective production of future medicines such as stem cell-based therapies in North Rhine-Westphalia.
Scaling up therapeutics
In order for cell therapeutics to be used cost-effectively, a sufficiently large number of cells - usually several billion - must be available. To achieve this, cells are expanded, i.e. multiplied, in bioreactors. At present, this expansion can usually only be carried out in very small volumes and with special equipment for certain cell types. For the pharmaceutical industry, this leads to extremely high production and thus therapy costs.
Cell expansion in a bioreactor
The “RauPE” project aims to develop a robust automated expansion platform for the cost-effective production of stem and cell therapies, in this case MSC-EVs, based on a membrane stirrer bioreactor. Extracellular vesicles (EVs) are produced by mesenchymal stem cells and extracted from the cell culture medium. Traditionally, EV-producing stem cells are cultured in culture plates. However, this cultivation is inefficient and requires a lot of space and manual labor. The project will develop disposable membrane cartridges that enable robust cell expansion of sensitive cells in a stirring-tank bioreactor. These cartridges will be used for the first time for the expansion of stem cells and will also be used for the establishment of new (EV)-based therapies, e.g. for immortalized mesenchymal stem cells (ciMSCs). These can be used to treat inflammatory disease, such as osteoarthritis or stroke.
Automation of the production processes
In order to develop robust production processes, the developed cartridges and the ciMSC expansion process will be integrated into an automated production platform at the Fraunhofer IPT. Based on the "AUTOSTEM" platform, a fully automated production of MSC-EVs from sample processing, bioreactor control and growth analysis to final cell removal will be achieved. The project will be completed by the establishment of an individual test procedure. The pre-therapeutic screening procedure will make it possible to predict whether individual patients who could benefit from MSC-EVs are likely to respond to appropriate therapeutics.
A consortium consisting of BioThrust, University Clinic Essen and Fraunhofer IPT combines expertise in medical biotechnology, bioprocess engineering and process automation. The cooperation of the partners is an optimal prerequisite for solving existing challenges in the large-scale production of cell therapeutics.
Project partners
- BioThrust, Aachen
- University Clinic, Essen
- Fraunhofer IPT, Aachen
Funding information
The “RauPE” research project is funded by the Ministry of Economic Affairs, Industry, Climate Protection and Energy of the State of North Rhine-Westphalia and with EU funds from the ERDF/JTF program NRW.
Funding reference number: EFRE-20800447