RoosterBio has signed a strategic collaboration with Sartorius, aiming to to advance the scale-up of hMSC manufacturing for regenerative medicine.
The companies will create a set of GMP-compatible, customer-centric protocols using RoosterBio’s hMSC and media systems, alongside Sartorius’s single use manufacturing technologies, process control software and cell analysis tools of hMSC final product manufacturing. Cell expansion will be reportedly optimised using Sartorius’s benchtop Ambr system and MODDE design of experiment software allowing the technical team to compare cultures in identically sized, multi-parallel bioreactors to gain process information and optimized conditions in a short timeline.
Sartorius’s 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 2000 L. Sartorius equipment will also be used to develop post-harvest processing methods with the kSep system as well as process and quality analytics. The joint effort aims to simplify multiple steps in therapeutic development by providing end-to-end platform technologies and protocols that can be implemented for rapid scale up of manufacturing processes.
“Taking hMSC manufacturing to the thousand-litre scale is critical in meeting product dose requirements in commercial manufacturing,” said RoosterBio CEO Margot Connor. “For truly robust and standardized production in the field, a highly controlled manufacturing strategy is needed, with the implementation of automation, process monitoring and control to increase batch scale, consistency and efficiency. This collaboration is well-positioned to accomplish the clinical scale requirements of regenerative medicine product developers while laying foundation for true commercial scale manufacturing.”
“With the combination of technologies and tools of RoosterBio and Sartorius we support our customers to develop stem cell and therapies faster, better and more cost-efficient. Scalability is key in commercial manufacturing and this cooperation will help to meet the requirements of our customers even better,” said Hugo de Wit, Head of Advanced Therapies at Sartorius.