Joint AutoCRAT paper in Processes from Fraunhofer IPT and U of Galway

Congratulations to AutoCRAT researchers at Fraunhofer IPT and the University of Galway for their recent publications in the journal Processes (ISSN 2227-9717). It will be part of a special issue, “Application of Deep Learning in Pharmaceutical Manufacturing”

The article is titled: Automated Production at Scale of Induced Pluripotent Stem Cell-Derived Mesenchymal Stromal Cells, Chondrocytes and Extracellular Vehicles: Towards Real-Time Release. Author/researchers Laura Herbst, Ferdinand Groten, Mary Murphy, Georgina Shaw, Bastian Nießing, and Robert H. Schmitt published the paper on October 10th, 2023. Download the PDF here.

Citation:

Herbst L, Groten F, Murphy M, Shaw G, Nießing B, Schmitt RH. Automated Production at Scale of Induced Pluripotent Stem Cell-Derived Mesenchymal Stromal Cells, Chondrocytes and Extracellular Vehicles: Towards Real-Time Release. Processes. 2023; 11(10):2938. DOI: https://doi.org/10.3390/pr11102938

Abstract: 

Induced pluripotent stem cell (iPSC)-derived mesenchymal stem cells (iMSCs) are amenable for use in a clinical setting for the treatment of osteoarthritis (OA), which remains one of the major illnesses worldwide. Aside from iPSC-derived iMSCs, chondrocytes (iCHO) and extracellular vesicles (EV) are also promising candidates for the treatment of OA. Manufacturing and quality control of iPSC-derived therapies is mainly manual and thus highly time-consuming and susceptible to human error. A major challenge in translating iPSC-based treatments more widely is the lack of sufficiently scaled production technologies from seeding to fill-and-finish. Formerly, the Autostem platform was developed for the expansion of tissue-derived MSCs at scale in stirred tank bioreactors and subsequent fill-and-finish. Additionally, the StemCellDiscovery platform was developed to handle plate-based cultivation of adherent cells including their microscopic analysis. By combining the existing automation technology of both platforms, all required procedures can be integrated into the AutoCRAT system, designed to handle iPSC expansion, differentiation to iMSCs and iCHOs, pilot scale expansion, and formulation of iMSCs as well as extracellular vesicles and their purification. Furthermore, the platform is equipped with several in-line and at-line assays to determine product quality, purity, and safety. This paper highlights the need for adaptable and modular automation concepts. It also stresses the importance of ensuring the safety of generated therapies by incorporating automated release testing and cleaning solutions in automated systems. The adapted platform concepts presented here will help translate these technologies for clinical production at the necessary scale.