From laboratory to clinic: Bridging regulatory and manufacturing gaps in stem cell-based therapies

Figure 7 Overview of mesenchymal stem cell-derived extracellular vesicle production, therapeutic applications, and key barriers to translation. This schematic summarizes the pathway from mesenchymal stem cells (MSCs) to the generation of therapeutic extracellular vesicles. MSC-EVs3*6 mediate immunomodulatory and reparative effects applicable to ischemic and inflammatory disorders. Scalable manufacturing requires upstream MSC expansion, controlled bioreactor cultivation, and downstream concentration via tangential flow filtration. Critical obstacles that remain include the establishment of reproducible manufacturing workflows, adherence to evolving regulatory expectations, development of reliable potency assays, and implementation of standardized criteria to ensure consistent product quality and clinical performance. MSC: Mesenchymal stem cell; TFF: Tangential flow filtration.