hMSC-derived extracellular vesicles production in the scale-X™ hydro fixed-bed bioreactor

Scalable and continuous extracellular vesicle production in fixed-bed bioreactors

The broad therapeutic potential and spectrum of applications of extracellular vesicles (EVs) have 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. Yet, they are often facing 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, offering a scalable range that can cater to both small-scale requirements in proof-of-concept studies, mid-scale clinical studies, as well as to large-scale biomanufacturing needs.

Producing EVs in scale-X hydro bioreactors in collaboration with Roosterbio Inc.

In January 2022, Univercells Technologies, a provider of novel biomanufacturing technologies for scalable and flexible production of advanced therapies, entered a collaboration with RoosterBio Inc., a supplier of human mesenchymal stem cells (hMSCs), highly engineered media, and hMSC bioprocess systems. This collaboration aimed to study the feasibility of using Univercells Technologies’ 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 demonstrated that the scale-X hydro bioreactor has proven successful 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. The design of scale-X fixed-bed bioreactors presents large surface area and flexibility, which enable longer cell growth and EV collection time windows, and therefore, EVs can be harvested by either media exchange or potentially by perfusion.

Interested? Download the article to read more about how to overcome challenges in EV manufacturing!

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