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Sartorius and RoosterBio will work together to address purification challenges and establish scalable downstream manufacturing processes for exosome-based therapies.
Sartorius, a life sciences research group, and RoosterBio, a biotechnology company focused on human mesenchymal stem/stromal cell (hMSC) and extracellular vesicle (EV) product and process development, announced the extension of a strategic collaboration on Jan. 5, 2023. This extension builds on an existing two-year collaboration that focused on the industrialization of cell-based regenerative cures; the goal of the new partnership is to work together to address purification challenges and establish scalable downstream manufacturing processes for exosome-based therapies.
According to a company press release, the partnership is attempting to produce a hMSC-based exosome production platform that can deliver industry-leading yield, purity, and potency. The collaboration will also focus on the development of comprehensive analytical techniques for exosome characterization, as well as the entire spectrum of EVs, to establish quantitative strategies for quality control of exosome purification intermediates and final drug product.
“Sartorius is delighted to enter into a collaboration with RoosterBio to develop a robust process for Exosome production,” said Michaela Pischke, head of Business Area Separation Technologies, Sartorius, in the press release. “Together we merge our technologies, RoosterBio’s clinical MSC & EV solution portfolio and Sartorius’ regulatory-compliant bioprocess manufacturing solutions, and industry expertise to deliver the bundled solutions for enabling fast-track early drug development and robust, cost-effective, scalable manufacturing process for exosomes.”
“We are delighted to continue our highly impactful partnership with Sartorius, as this collaboration builds upon our previous process development initiative to establish scalable stirred tank bioreactor expansion processes for hMSCs,” said Tim Kelly, CEO, RoosterBio, in the press release. “Exosomes offer extremely high utility as a new therapeutic modality with the potential to address unmet medical needs. The cell and gene therapy industry will greatly benefit from access to robust, scalable, end-to-end solutions for the production and characterization of native and engineered exosome therapeutics.”