Sartorius and RoosterBio partner to advance scale-up of hMSC manufacturing

The collaboration aims to accelerate the development and commercialization of groundbreaking cell-based regenerative cures

The collaboration will focus on advancing the scale-up of hMSC manufacturing for regenerative medicine to significantly reduce process development efforts, industrialize the supply chain, and accelerate the development and commercialization of groundbreaking cell-based regenerative cures.

RoosterBio and Sartorius will create a set of Good Manufacturing Practice-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 rapidly optimized 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.

The company'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 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.

According to the companies, this joint effort will simplify multiple steps in therapeutic development by providing robust, streamlined, end-to-end platform technologies and protocols that can be implemented for rapid scale-up of manufacturing processes, allowing product developers to significantly speed up their development timelines.

“Taking hMSC manufacturing to the thousand-liter scale is critical in meeting product dose requirements in commercial manufacturing,” said RoosterBio CEO Margot Connor.

Commenting further on the collaboration, she described the companies as "well-positioned to accomplish the clinical scale requirements of regenerative medicine product developers while laying the foundation for true commercial-scale manufacturing".

Both companies aim to use the data from this collaboration to provide co-learning and development opportunities to support the growing cell and gene therapy industry.