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The broad therapeutic potential of extracellular vesicles (EVs) has sparked great interest across the scientific community, and a growing number of EV-based clinical trials highlight the need for a scalable and efficient EV manufacturing process.
EVs are often produced using adherent-based cell cultures, which currently rely on 2D systems (e.g., plastic flatware), hollow-fiber bioreactors, and stirred-tank bioreactors with microcarriers. However, these systems pose challenges in terms of scalability, productivity, and continuous manufacturing.
Univercells Technologies’ scale-X™ structured fixed-bed bioreactors offer a platform that can address these challenges for efficient adherent cell EV manufacturing. Scale-X bioreactors provide scalability, ranging from proof-of-concept studies to mid-scale clinical studies and large-scale clinical manufacturing.
In January 2022, Univercells Technologies entered a collaboration with RoosterBio Inc., a supplier of human mesenchymal stem cells (hMSCs), highly engineered media and hMSC, and EV Production Platforms for R&D and Clinical Manufacturing. This collaboration aimed to study the feasibility of using scale-X bioreactor systems as scalable platforms for continuous and high-capacity manufacture of hMSC-EVs in a reduced footprint.
The results presented in this study demonstrate proven success in the transfer of EV-producing hMSC cultures from 2D systems, providing more than a 2-fold increase in EV productivity compared to their flatware counterparts.
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