Sartorius has extended a strategic collaboration agreement with RoosterBio Inc. to address purification challenges and establish scalable downstream manufacturing processes for exosome-based therapies. The companies will provide solutions and expertise for a human mesenchymal stem/stromal cell (hMSC) – based exosome production platform that aims to deliver industry-leading yield, purity, and potency. This collaboration will also focus on the development of comprehensive analytical techniques for the characterization of exosomes and the entire spectrum of extracellular vesicles (EVs) to establish quantitative strategies for quality control of exosome purification intermediates and final drug product. 
 
Sartorius and RoosterBio have been collaborating in the field of Cell and Gene therapy for almost two years for the industrialization of cell-based regenerative cures. This agreement takes a step further to commercialize the Exosome production and purification process using our technologies.
 
The compnaies will develop scalable platform purification processes using Sartorius’ solutions to maximize exosome productivity while maintaining therapeutic attributes. Sartorius’s Biostat STR® manufacturing bioreactor platform, process analytical technologies (PAT) toolbox, along with RoosterBio’s hMSC banks, RoosterNourish™ hMSC cell growth medium, and RoosterCollect™ EV production medium will be used for upstream manufacture of exosomes at large scale.  
 
For the development of downstream purification methods, Sartorius’s scalable filtration equipment, Sartoflow® Smart and Sartoflow® Advanced will be leveraged for clarification, concentration, and formulation of exosomes in combination with column chromatography unit operations. Sartorius’ analytical platforms, including PATfix® HPLC, Virus Counter®, and Incucyte®, will be utilized for automated real-time process analysis and evaluation of purification process efficiency. This collaborative development effort, conducted in RoosterBio’s process development labs in Frederick, MD, aims to simplify multi-step therapeutic development processes by providing robust, end-to-end platform technologies and protocols that researchers can easily adopt to accelerate development timelines and incorporate a scalable platform approach into their manufacturing processes.