PhD Project: Development of Physiological Potency Assays for Cell-Based Therapies

Sabrina Nebel – Doctoral Candidate DocSchool BioMatInt

In recent years advanced medicinal products (ATMPs), such as tissue engineering, cell and gene therapy have emerged. As they present unique challenges in their development, new testing systems have to be developed to still ensure efficiency – so called potency assays.

Current cell-based potency assays mainly rely on static 2D culture of transformed cell lines, which makes them well-defined and reproducible but far off from physiological conditions. Especially in early stages of drug development and characterization, testing system should emulate the actual circumstances. Considering all these aspects, new bioprocess strategies to provide a physiological-like potency assay platform considering the biomaterial, the physiological 3D environment, and the implemented cells, have to be developed. As a prerequisite, already upon retrieval from the donor tissue, the cells need to be provided with an in vivo-like environment.

Thus, we aim to develop well defined cultivation solutions that cover isolation of primary cells, their expansion and lastly translation to a potency assay platform.

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Related to the workpackage “Maintainance & Expansion”, we published a paper with the title “Alginate Core–Shell Capsules for 3D Cultivation of Adipose-Derived Mesenchymal Stem Cells” in MDPI Bioengineering. More details on this can be found here or you can check out the original publication here.