Scale up MSC-derived extracellular vesicle (EV) production with closed, low-shear processing
Extracellular vesicles (EVs), including exosomes derived from mesenchymal stromal cells (MSC-EVs), show promise in regenerative medicine and drug delivery, but their fragility and heterogeneity make purification and scale-up difficult. In this collaborative study with RoosterBio®, a scalable process platform was developed that replaces traditional harvest centrifugation with tangential flow depth filtration (TFDF®) for clarification and tangential flow filtration (TFF) for concentration and buffer exchange, supporting robust parameter transfer from development to manufacturing scale.
Key takeaways
TFDF clarification delivered >60% turbidity reduction (average reported: 60.3%) while maintaining EV integrity.
- Up to 20× volume reduction with ~92% EV retention and <1% permeate breakthrough in multi-liter runs.
- Lower footprint and consumables: >4× reductions in media and nuclease usage at the 200 L scale.
What you’ll get in the application note
- An end-to-end overview of a closed, scalable MSC-EV manufacturing workflow, from 2D seed train through microcarrier-based bioreactor production and EV collection.
- How TFDF in clarification mode can replace centrifugation and help de-risk scale-up with low-shear processing.
- Practical UF/DF recipe (concentrate/DF/concentrate) and MWCO screening insights and technology blueprint to support retention, flux, and reproducibility.
Who this is for
This application note is designed as a blueprint for process development, MSAT, and CMC teams working on EV/exosome therapeutics who need scalable clarification and UF/DF strategies that maintain product quality while reducing time and cost.
