- FibroBiologics and Charles River Laboratories have signed a master services agreement for the development and manufacturing of CYWC628, a fibroblast-based product for a 2025 clinical trial.
- The technology transfer for CGMP manufacturing has been completed, with Charles River serving as the CDMO for the diabetic foot ulcer treatment.
FibroBiologics and Charles River Laboratories have entered a master services agreement to develop and manufacture FibroBiologics’ fibroblast-based therapeutic product, CYWC628. This product is set to be used in a diabetic foot ulcer (DFU) clinical trial scheduled to begin in 2025.
FibroBiologics is focused on developing treatments for chronic diseases using fibroblast cells, with over 160 patents supporting their work. The clinical trial for CYWC628 will test the product’s potential in wound healing, with diabetic foot ulcers being a primary focus.
The agreement follows the successful completion of a technology transfer from FibroBiologics to Charles River, including feasibility studies on the proprietary cell manufacturing processes. Under the terms of the agreement, Charles River will serve as the contract development and manufacturing organisation (CDMO), using its CGMP facilities to produce the drug product for the upcoming trial.
Charles River’s role in this project highlights its capabilities in cell and gene therapy CDMO services, which encompass the production of plasmid DNA, viral vectors, and cell therapies. The company’s global manufacturing and testing services aim to streamline supply chains for advanced therapies.
Pete O’Heeron, CEO of FibroBiologics, said: “The formalization of our working relationship with Charles River is a pivotal step as we advance toward a significant wound care clinical trial in 2025 with CYWC628.”
Overview of outsourcing trends 
