AGC Biologics announced a strategic partnership with RoosterBio, a supplier of human mesenchymal stem/stromal cells (hMSCs) and bioprocess development services, to accelerate cell and exosome manufacturing capabilities.
Key highlights:
- Exosome therapy development sees challenges in accessibility and reaching the clinic as a treatment option.
- The partnership between RoosterBio and AGC Biologics creates an end-to-end solution for the development and production of hMSC and exosome therapeutics.
- RoosterBio will utilise its extensive portfolio of cell and media products to develop robust, scalable processes for hMSC and exosome therapies.
- AGC Biologics will contribute its global network to provide full services for pre-clinical and phase I/II clinical trials, with the ability to scale to Phase III and commercial production.
Exosomes have seen exponential growth in biomedical research usage in recent years. These growth rates indicate that this cell type is becoming a popular choice amongst developers to help develop the cell and gene product pipeline. However, access to exosome cell and media development can be limited, and a strong manufacturing network to get treatments into the clinic can deem challenging. However, this partnership hopes to combat these issues, and give cell and gene developers the end-to-end services they need.
The partnership creates an end-to-end solution for the development and production of hMSC and exosome therapeutics leveraging RoosterBio’s well-established cell and media products and process development services, coupled with AGC Biologics’ global cell and gene therapy manufacturing capabilities.
RoosterBio will utilise its extensive 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 characterisation of the resulting formulated cell or exosome therapy.
AGC Biologics will utilise 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 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. The global CDMO’s network of sites offers the latest cell therapy technologies and processes, including allogenic and autologous systems and techniques.
"ACG Biologics is 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," 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, added: “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.”
More details on this partnership and the joint offering from RoosterBio and AGC Biologics will be released in the coming months.
AGC Biologics’ global cell therapy services and viral vector capabilities utilise proprietary platforms developed to address the evolving advanced therapies market. To learn more about the company and its complete list of CDMO services visit www.agcbio.com.