FibroBiologics and Charles River have signed a master services agreement to develop and manufacture FibroBiologics’ therapeutic cell banks and fibroblast-based product CYWC628.
The therapeutic cell banks and CYWC628 are intended for use in a diabetic foot ulcer (DFU) study, planned to begin in 2025.
FibroBiologics is a clinical-stage biotechnology company developing potential treatments for chronic diseases using fibroblasts and fibroblast-derived materials.
The biotechnology company has more than 160 patents issued and pending for its fibroblast-derived therapeutics.
FibroBiologics is investigating the potential treatment of chronic diseases using the immunomodulatory and regenerative capabilities of fibroblasts and fibroblast-derived materials.
It is working on indications including wound healing, multiple sclerosis, degenerative disc disease, psoriasis, thymic involution reversal, and cancer.
FibroBiologics founder and CEO Pete O’Heeron said: “The formalisation 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.
“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.”
The master services agreement follows the feasibility studies on FibroBiologics’ unique cell manufacturing processes, which showed positive results.
Under the terms of the agreement, Charles River will serve as the contract development and manufacturing organisation (CDMO) to produce the drug products for the clinical trial.
FibroBiologics has already completed technology transfer with Charles River, for current good manufacturing practice (CGMP) manufacturing of the therapeutics.
Charles River’s cell and gene therapy CDMO portfolio helps to simplify complex supply chains and meet the increasing demand for plasmid DNA, viral vector, and cell therapy services.
Charles River global manufacturing corporate senior vice president Kerstin Dolph said: “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.”
Earlier this year, Charles River signed a strategic agreement with Wheeler Bio focused on the preclinical and early clinical supply of recombinant proteins.
