The collaboration draws on RoosterBio’s cell and media products and process development services, coupled with AGC Biologics’ cell and gene therapy manufacturing capabilities.
Frederick, Maryland-headquartered RoosterBio will use its portfolio of cell and media products to develop ‘robust, scalable processes’ for hMSC and exosome therapies.
These capabilities include genetic engineering of cells and exosomes to express therapeutic targets, upstream processing in both 2D flask and 3D bioreactor systems, downstream purification to achieve desired purity and potency, and comprehensive analytical characterization of the resulting formulated cell or exosome therapy.
Meanwhile, Seattle-headquartered AGC Biologics will contribute its global network to provide full Process Development, cGMP Manufacturing, Quality Control and Regulatory services for pre-clinical and phase I/II clinical trials, with the ability to scale to Phase III and commercial production.
The CDMO has a global network of sites dedicated to cell therapy technologies and processes, including allogenic and autologous systems and techniques.
More details on this partnership will be released in the coming months.
"RoosterBio has a reliable method for producing engineered cells and exosomes that can help developers create life-saving therapies," said Patricio Massera, Chief Executive Officer of AGC Biologics. "When you combine their work and expertise with AGC Biologics' scientific knowledge and global manufacturing services, it creates a comprehensive offering that can help these developers save time and money, and get their treatments in the hands of patients in need."
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