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.