Redefining extracellular vesicle production: proof of concept study evaluating structured fixed-bed bioreactor for high-capacity production

Discover how Univercells Technologies’ scale-X™ fixed-bed bioreactors achieved 2-fold increase in EV productivity enabling scalable production from proof-of-concept to large-scale continuous manufacturing

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.

Learning points

  • Overcoming challenges associated with 2D systems, hollow-fiber bioreactors, and stirred-tank bioreactors with microcarriers for efficient EV manufacturing process
  • A feasible platform for scalable, continuous, and high-capacity manufacture of xeno-free hMSC-EVs in a reduced footprint
  • How to achieve 2-fold increase in EV productivity
  • How a platform of high-quality working cell banks and highly productive media systems can enable the rapid production of exosomes without media changes
  • An approach for facilitating the rapid translation of an exosome product from development to clinical manufacturing

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About our experts

Effie Huang is a bioprocessing field application scientist for Univercells Technologies. She enjoys helping her customers in the cell and gene therapy industry achieve their goals, whether those are increasing productivity, streamlining process steps, or troubleshooting technological issues. In her current role, she supports customers with learning and adapting to new platform technology for upstream bioprocessing. She has helped multiple customers with no previous bioreactor experience in accomplishing proof of concept studies and successfully transitioning from manual process steps to a continuous and automated process using Univercells Technologies scale-X bioreactors

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