AGC Biologics has announced its partnership with supplier of human mesenchymal stem/stromal cells (hMSCs), RoosterBio Inc.
The partnership, the companies say creates an end-to-end solution for the development and production of hMSCs and exosome therapeutics using RoosterBio’s well-established cell and media products and process development services together with AGC’s cell and gene therapy manufacturing capabilities.
RoosterBio, that also supplies engineered media and bioprocess development series, has means that include genetic engineering of cells and exosomes to express therapeutic targets, upstream processing in both 2D flask and bioreactor systems, downstream purification to achieve desired purity and potency and comprehensive analytical characterization of the resulting formulated cell or exosome therapy.
Tim Kelly, chief executive officer of RoosterBio, said: “AGC Biologics has an outstanding track record of success in the manufacture of clinical and commercial advanced therapies and an ever-expanding global network to meet the needs of our customers.
“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.”
CDMO (contract development and manufacturing organization) AGC Biologics will provide full process development, cGMP manufacturing, quality control and regulatory services for pre-clinical and phase 1 and 2 clinical trials, with the ability to scale to phase 3 and commercial production.
The CDMO also offers a range of development and manufacturing scales that can be tailored to the specific needs of drug developers in different regions worldwide. The AGC Biologics scientific teams have over two decades of experience in advanced therapy production and manufacturing, and have brought three commercial products to market. Its network of sites offers the latest cell therapy technologies and processes, including allogenic and autologous systems and techniques.
Patricio Massera, chief executive officer of AGC Biologics, said: “We are happy to be partnering with RoosterBio. They have a reliable method for producing engineered cells and exosomes that can help developers create life-saving therapies.
“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.”
Last month (July) AGC Biologics entered into another partnership with gene therapy company, Altheia Sciences, which pioneers cell and gene treatments, to look at strategies to treat autoimmune disease and cancer.