The extended collaboration sees Sartorius and RoosterBio aim to commercialize exosome production and purification processes using various technologies. 

The partnership between Sartorius and RoosterBio began almost two years ago. The firms teamed up to find ways of scaling-up production of stem cell-based regenerative therapies and combined Rooster’s human mesenchymal stem/stromal cell (hMSC) working cell banks and media systems with Sartorius’ single-use manufacturing tech, process control software and analysis tools.

Now, both parties say the extended partnership looks to “take a step further” by commercializing the exosome production and purification processes using Sartorius’ technologies.

DepositPhotos/IgorTishenko

Together, the firms will advance scalable platform purification processes using Sartorius’ Biostat STR manufacturing bioreactor platform and its process analytical technologies (PAT) toolbox. This will be used alongside RoosterBio’ hMSC banks, RoosterNourish hMSC cell growth medium, and RoosterCollect EV production medium, which will be used for upstream manufacture of exosomes at large scale.

“Sartorius, a leading solutions provider is delighted to enter into a collaboration with RoosterBio to develop a robust process for Exosome production,” said Michaela Pischke, head of the business area separation technologies at Sartorius.

“With advanced and innovative Sartorius downstream technologies for both chromatography and filtration along with state-of-the-art analytical tools, we would work with RoosterBio team for process development for this emerging modality.”

Furthermore, the partnership will also focus on the development of techniques for the characterization of exosomes and the extracellular vesicles (EVs) needed to form quantitative strategies for quality control and final drug product.

In addition to Sartorius’ Biostat STR manufacturing bioreactor platform and its PAT toolbox, its Incucyte, Virus Counter, and PATfix HPLC will also be used for automated real-time process analysis and assessment of purification process effectiveness.

Moreover, for downstream purification methods, Sartorius’ filtration equipment such as Sartoflow Smart and Sartoflow Advanced will be used to formulate exosomes alongside column chromatography unit operations.

The collaboration is being conducted in RoosterBio’s laboratories in Frederick, Maryland and both parties will leverage data from the partnership in order to provide technology presentations, guidance materials, and application notes to outline the challenges faced in the biomanufacturing space.