FibroBiologics Inc., a clinical-stage biotechnology company, and Charles River Laboratories, a global drug discovery, development, testing, and manufacturing solutions provider, have established a master services agreement to develop and manufacture FibroBiologics’ therapeutic master cell bank, working cell bank, and fibroblast-based spheroids product, CYWC628, for utilization in a diabetic foot ulcer (DFU) clinical trial slated to begin in 2025.
 
FibroBiologics is investigating the potential treatment of chronic diseases using the immunomodulatory and regenerative capabilities of fibroblasts and fibroblast-derived materials. Indications being studied include wound healing, multiple sclerosis, degenerative disc disease, psoriasis, thymic involution reversal, and cancer.
 
The technology transfer from FibroBiologics to Charles River for current good manufacturing practice (CGMP) manufacturing has been successfully completed, along with feasibility studies evaluating FibroBiologics’ proprietary cell manufacturing processes. With the positive results from these feasibility studies and the signed master services agreement, Charles River will now serve as the contract development and manufacturing organization (CDMO), to produce the drug products for FibroBiologics’ upcoming clinical trial.
 
Charles River’s cell and gene therapy CDMO portfolio helps to simplify complex supply chains and meet growing demand for plasmid DNA, viral vector, and cell therapy services. Combined with Charles River’s legacy testing capabilities, Charles River offers an industry-leading “concept to cure” advanced therapies solution.
 
“Charles River’s work with FibroBiologics is part of a larger commitment to supporting next-generation regenerative medicine through the adoption of innovative therapies. We are excited to collaborate with FibroBiologics and support the development of a therapy that has the potential to transform patient care for those impacted by diabetic foot wounds,” said Kerstin Dolph, Corporate Senior Vice President, Global Manufacturing, Charles River.
 
“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,” said Pete O’Heeron, Founder and CEO of FibroBiologics. “Working with Charles River opens new possibilities for innovation with its global reach and scalability potential. By combining our unique therapeutic fibroblast-based spheroids approach with Charles River’s expertise and unparalleled support, we are positioned to accelerate progress in delivering this treatment to patients.”