The collaboration draws on RoosterBio’s cell and media products and process development services, coupled with AGC Biologics’ cell and gene therapy manufacturing capabilities.
The two companies see 'tremendous opportunities' in EVs/exosomes: with projections suggesting a CAGR of 31% (2015-2030) for the market, reaching the $1bn mark by 2027.
In published biomedical research, this subject area now exceeds monoclonal antibodies and liposomes, note the companies: who draw a comparison to a similar pace of growth for monoclonal antibodies during the 1980s ahead of their boom (with this sector now worth around $100bn in global annual sales).
RoosterBio and AGC Biologics believe these research growth rates indicate this cell type is becoming a popular choice amongst developers to help advance the cell and gene product pipeline.
However, access to exosome cell and media development and manufacturing facilities to get treatments into the clinic is still scarce: with the new partnership seeking to bridge this gap and give cell and gene developers end-to-end services.
Combining expertise and manufacturing capabilities
In the new partnership, Frederick, Maryland-headquartered RoosterBio will use its portfolio of cell and media products to develop ‘robust, scalable processes’ for human mesenchymal stem/stromal cells (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."
Tim Kelly, Chief Executive Officer of RoosterBio, said: “Biopharmaceutical companies striving to develop engineered cell and exosome therapies require proven, flexible technologies paired with reliable and scalable manufacturing solutions. This collaboration was conceived to deliver that end-to-end solution for our customers and I am thrilled to partner with AGC Biologics to translate our hMSC and exosome technologies into advanced therapy products that have the potential to bring curative treatments to patients in need.”
