Univercells and RoosterBio target regen med commercialization

The partnership aims to enhance manufacturing of extracellular vesicles (EVs) using continuous bioprocessing technologies to make regenerative medicine cheaper.

The aim of the collaboration is to deliver exosome manufacture, using Univercells’ scale-X hydro fixed-bed bioreactor and RoosterBio’s human mesenchymal stem/stromal cells (hMSC) bioprocess and engineering media systems to establish EV produ ction.

“A first step will be to evaluate the performance of the EV manufacturing process in the scale-X bioreactor and benchmarking it against a reference process (microcarriers process in the Ambr 250 or 2D flasks). Then the team will optimize the process to achieve productivity and quality targets,” a spokesperson for RoosterBio said.

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“The team will then further collaborate to develop continuous process in perfusion mode and look into scale-up into the scale-X carbo bioreactor (10 and 30 m² cell growth surface). By transferring their EV process to the scale-X platform, the teams mean to attain higher productivities within a reduced footprint while increasing process reliability. This will be critical to advance EV production towards the required quantity and quality needed for commercialization, eventually contributing to making theses therapies available to the patients.”

According to both firms, the collaboration allows developers to shorten timelines, decrease costs, and manufacture regenerative therapies via the platform.  Additionally, Univercells and RoosterBio will consider extending this study.

Understanding technologies

Marie Jourdan, VP marketing and product management at Univercells Technologies told BioProcess Insider its single-use scale-X portfolio can offer growth surface areas from 2.4 m² up to 600 m², which provides “significant increase of the surface area/volume ratio compared to conventional technologies. Its scalable design allows for constant linear velocity of fluids, delivering homogeneous environment for cell growth and even distribution at all scales, ensuring predictable cell & product behavior and smooth scale-up.”

Meanwhile, RoosterBio’s hMSC media system “is engineered to be a scalable solution that provides consistent and rapid cell expansion throughout the development process,” the spokesperson said.

The solution is made up of two components: RoosterNourish media expansion and RoosterReplenish bioreactor feed. The firm said RoosterNourish does not need additional surface coating for rapid cell expansion and a media exchange-free process. It can also generate over 10-fold cell yields in four to five days per passage.

RoosterReplenish “is a 3D bioreactor feed for the scalable removal of in-process media replacement and is available in xeno-free and cGMP formats. Regardless of scale, our system generates consistent population doubling levels that are optimized for therapeutic use two passages from our working cell banks. These materials are backed by Type II Drug Master Files with the FDA to streamline regulatory filing,” said the spokesperson.