FibroBiologics has entered a master services agreement with Charles River Laboratories to develop and manufacture cell-based therapies for chronic diseases.
The agreement will involve the manufacture of FibroBiologics’ working cell bank, therapeutic master cell bank and CYWC628, for use in a diabetic foot ulcer (DFU) clinical trial, which is expected to commence in 2025.
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CYWC628 is a fibroblast-based spheroids product.
FibroBiologics has concluded the technology transfer to Charles River for current good manufacturing practice (CGMP) manufacturing.
Feasibility studies have also been conducted, confirming the viability of FibroBiologics’ cell manufacturing processes.
The collaboration with FibroBiologics leverages Charles River’s extensive testing capabilities, offering a comprehensive “concept to cure” solution in advanced therapies.
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By GlobalDataCharles River Global Manufacturing corporate senior vice-president Kerstin Dolph stated: “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.”
With the master services agreement in place, Charles River will act as the contract development and manufacturing organisation (CDMO) for FibroBiologics.
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.”
FibroBiologics is investigating the potential of fibroblasts and fibroblast-derived materials in treating chronic diseases. These include multiple sclerosis, wound healing, degenerative disc disease, thymic involution reversal, psoriasis and cancer.
In June 2024, Charles River signed an agreement with German company Captain T Cell to focus on the production of plasmid DNA and retrovirus vectors for gene-modified cell therapy.
