StemCellFactory III

Individualised pharmacotherapy is increasing in importance within the context of personalized medicine. In this, determination of active ingredient, dosage of the active ingredient and the forecast of adverse drug effects represent the central parameters. Until now, these types of predictive studies were predominantly based on genetic testing or clinical findings. The most recent advances in the area of cell reprogramming open up the possibility of performing active ingredient testing directly using the human cells affected by the disease, which can be collected straight from the patient.

Funding Notes

In the StemCellFactory III project, which is now in the third funding phase, this unique resource will be used to develop cellular test systems for active ingredient testing and personalized pharmacotherapy in the area of neuropsychiatric diseases. Building on a structure unique in Europe for the automated cell reprogramming of skin fibroblasts (StemCellFactory) already developed by one of the project partners, in the now third project phase, procedures for automated creation of patient-specific and disease-specific induced pluripotent stem cells (iPS cells) are being created from easily collected blood samples. The recently available procedure of genome editing (CRISPR-Cas9) will be integrated as an automated mechanism in order to optimally reproduce the effect of individual genetic changes on the cellular disease processes. 3D aggregates (organoids) similar to brain tissue generated in a standard manner from the iPS cells will be utilized for metabolic testing on patient-specific active ingredient dosing as well as for the prediction of effect and adverse effects. Test systems and platform technologies will be generated for this for immediate use in treatment planning and development, which will be utilized by companies involved in the consortium and already established connections to external partners from the pharmaceutical industry.

More detailed information on the project and the technologies developed, as well as other news can be found on the project home page www.stemcellfactory.de.

The role of P3 aviation GmbH c/o umlaut consulting GmbH

Work package 6 - strategic project management & utilization - lead by umlaut, has the goal of making the research results usable by the parties involved and to map the path for potential customers on how one can undertake assessments to transfer the SCF III system or parts thereof into their own portfolios. This also applies to the research and future generation of cells and cell material and their programming. The project is equally a landmark for automation and cell production. umlaut is charged with utilizing both parts individually, but also with describing the interaction of system and cell reprogramming in such a way that potential customers or partners are aware of them. In addition, within the framework of the utilization strategy, umlaut will also develop a generic implementation plan for the implementation of the overall system (system components and cell production) in the individual companies.

The results to be expected mesh well with the currently growing market for innovative biotechnical processes, with a rising share in the area of cell reprogramming. With positive results in the Stem Cell Factory III project, the approaches can contribute significantly to the development of a modular and easily-to-implement cell reprogramming system through its unique selling points, and relevant products can be placed on the market accordingly.

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Project Partners

• Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)
  (Federal Institute for Drugs and Medical Devices)
• Fraunhofer-Institut für Produktionstechnologie IPT
  (Fraunhofer Institute for Production Technology)
• Lead Discovery Center (LDC)
• Life&Brain
• P3 aviation GmbH c/o umlaut consulting GmbH
• Aachen University Hospital (UKA)
• Bonn University Hospital (UKB)