Controlled Production Of MSC-Derived Extracellular Vesicles In Stirred-Tank Bioreactors

While extracellular vesicles show remarkable therapeutic promise, their manufacturing bottlenecks reveal a critical gap between biological potential and industrial reality. This case study examines the implementation of controlled bioreactor systems for reproducible, large-scale EV production.

Key focus areas include:

• Process Optimization: Systematic evaluation of stirred-tank bioreactor configurations compared to traditional static culture methods
• Quality Control Parameters: Identification and monitoring of critical process parameters affecting EV yield and characteristics
• Advanced Process Monitoring: Implementation of Raman spectroscopy for real-time nutrient analysis and process control

Conducted through a collaboration between iBET and the University of Navarra, this study demonstrates:

• The operational advantages of bioreactor systems in scaling EV production
• Methodologies for maintaining product consistency across production scales
• Technological approaches to address current manufacturing limitations

These findings contribute to the growing body of knowledge supporting the transition from research-scale to clinically relevant production volumes in cell-based therapeutics. Download the case study below to dive further into methodologies, comparative data analysis, and a comprehensive discussion of manufacturing implications.