RoosterBio, Sartorius partner on cell and gene therapy manufacturing

By The Science Advisory Board staff writers

January 15, 2021 -- RoosterBio and Sartorius have signed a strategic collaboration to advance the scale-up of human mesenchymal stem/stromal cell (hMSC) manufacturing for regenerative medicines.

The goal of the collaboration is to reduce process development efforts, industrialize the supply chain, and accelerate the development and commercialization efforts of cell-based regenerative cures.

RoosterBio and Sartorius will create a set of good manufacturing practice (GMP)-compatible, customer-centric protocols using RoosterBio's hMSC and media systems, alongside Sartorius' single-use manufacturing technologies, process control software and cell analysis tools of hMSC final product manufacturing. Cell expression will be optimized on Sartorius' Ambr system and Modde design of experiment software. Sartorius's scalable Biostat STR production bioreactors will then be used to scale up to 50 L as part of this collaboration, with the system benefitting from scalability to 2,000 L. Sartorius will also assist in the development of a postharvest processing method.

The joint efforts will be used simplify multiple steps in therapeutic development for rapid scale up of manufacturing processes. The companies plan to use the data to support the cell and gene therapy industry.

Financial details of the collaboration were not disclosed.

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