Sartorius and RoosterBio advance downstream purification of exosome production

GÖTTINGEN, Germany, Jan.
12, 2023 /PRNewswire/ -- Life sciences group Sartorius has expanded its strategic partnership agreement with RoosterBio Inc.
(RoosterBio) to address purification challenges and create scalable downstream processes
for exosome therapy.
Through this collaboration, Sartorius and RoosterBio will collectively provide best-in-class solutions and expertise for human mesenchymal stem cell/stromal cell (hMSC)-based exosome production platforms that deliver industry-leading yield, purity, and potency
.
In addition, the collaboration will focus on developing comprehensive analytical techniques for characterizing exosomes and all types of extracellular vesicles (EVs) to establish quantitative strategies
for exosome purification intermediates and end-drug product quality control.
Sartorius and RoosterBio have been working together in the field of cell and gene therapy for nearly two years, working to industrialize
cell regenerative therapies.
The two companies will now further deepen their collaboration and commercialize
exosome production and purification processes using each other's technologies.

Sartorius and RoosterBio will leverage Sartorius' comprehensive solutions to develop a scalable platform for purification processes that maximize exosome productivity
while maintaining therapeutic properties.
Sartorius' Biostat STR® bioreactor, Process Analytical Technology (PAT) and RoosterBio's hMSC library, RoosterNourish? hMSC Cell Growth Medium and RoosterCollect? EV medium will be used for upstream production
of exosomes on a large scale.
For the development of downstream purification technologies, Sartoflow Smart and Sartoflow®® Advanced, Sartoflow Smart, scalable filtration equipment from Sartorius, will be combined with column chromatography equipment for exosome purification, concentration, and preparation
.
Sartorius' bioanalytical platforms such as PATfix® HPLC, Virus Counter® and Incucyte® will be used for automated, real-time process analysis and purification efficiency assessment
.
The collaboration at the advanced RoosterBio Process Development Laboratory in Frederick, Maryland, USA, will result in robust end-to-end platform technologies and protocols that make it easy for scientists to accelerate R&D and integrate scalable platform approaches into the manufacturing process, simplifying the tedious therapeutic development process
.

"As a leading provider of bioprocessing solutions, Sartorius is excited to partner with RoosterBio to develop a robust exosome production process
.
With Sartorius' advanced and innovative chromatographic analysis and downstream filtration technologies, as well as state-of-the-art bioanalytical tools, we will work with the RoosterBio team on process development
for this emerging therapy.
" Michaela Pischke, head of Separation Technologies at Sartorius, said
.
We will integrate our technologies, including RoosterBio's portfolio of clinical MSC and EV solutions, as well as Sartorius' compliant bioprocessing solutions and industry expertise, to provide packaged solutions
that accelerate early-stage drug development and enable reliable, cost-effective, and efficient scale-up exosome manufacturing processes.
" "

"We are delighted to deepen this impactful partnership with Sartorius, which builds on our previous process development program to create a stirred tank bioreactor scale-up process
for hMSCs.
" Dr.
Tim Kelly, CEO of RoosterBio, said
.
"Exosomes are a novel type of therapy with extremely high utility to address unmet medical needs
.
The cell and gene therapy industry will greatly benefit from robust and scalable end-to-end solutions for the production and characterization
of natural and engineered exosome therapies.
By combining our industry-leading MSC and exosome technology platform with Sartorius' best-in-class bioprocessing solutions and expertise, we will bring transformative value to patients around the world and drive the clinical development
of these novel therapies.
" "

Sartorius and RoosterBio will use data from this collaboration to provide application notes, technology demonstrations and other guidance materials designed to address the major challenges
facing the biopharmaceutical industry.