The biotechnology sector is witnessing a significant advancement in cell and exosome therapy manufacturing as RoosterBio Inc. and Thermo Fisher Scientific announce a strategic partnership aimed at accelerating the development of potentially life-saving therapies for degenerative diseases.
The collaboration, announced on April 30, 2025, unites RoosterBio's specialized portfolio of human mesenchymal stem/stromal cell (hMSC) products and bioprocessing expertise with Thermo Fisher's advanced Good Manufacturing Practice (GMP) contract manufacturing capabilities. This partnership creates a comprehensive end-to-end solution for biopharmaceutical companies developing cell and exosome-based therapeutics.
Comprehensive Manufacturing Solution
Under the partnership, biopharmaceutical companies will gain access to RoosterBio's expertise in hMSC and exosome products, processes, and analytics, complemented by Thermo Fisher's established GMP manufacturing infrastructure. The manufacturing services will include upstream expansion of hMSCs, downstream purification of MSCs and MSC-derived exosomes, and drug product manufacturing.
Tim Kelly, Chief Executive Officer of RoosterBio, emphasized the significance of the collaboration: "Thermo Fisher has an exceptional track record of success in the manufacture of clinical and commercial cell and gene therapies and a well-established 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 capabilities."
Kelly added that the partnership will deliver a comprehensive solution to customers, translating RoosterBio's MSC and exosome technologies into advanced therapy products for patients worldwide.
Accelerating Clinical Development
The partnership is expected to significantly reduce timelines for the production of clinical trial materials, addressing a critical bottleneck in the advancement of cell and exosome therapies to clinical stages. By streamlining manufacturing processes, the collaboration aims to help promising therapies reach patients more quickly.
Ben Castro, Vice President and General Manager of Large Molecule pharma services at Thermo Fisher, highlighted the shared mission behind the collaboration: "Our collaboration with RoosterBio reflects our shared commitment to helping life-changing therapies reach patients in need, in the safest, fastest and most effective way possible."
Castro expressed enthusiasm about expanding Thermo Fisher's Contract Development Manufacturing Organization (CDMO) services to support biotechnology partners throughout the research, optimization, process development, and manufacturing stages of critical treatments.
Quality and Ethical Standards
RoosterBio maintains rigorous bioethical standards in its operations, with hMSCs sourced under stringent guidelines and manufactured using highly standardized processes. The company's products are supported by first-in-class characterization, ensuring safety and efficacy in accordance with global best practices.
The partnership represents a significant step forward in addressing manufacturing challenges that have historically limited the clinical translation of cell and exosome therapies. By combining specialized expertise in hMSC biology with industrial-scale manufacturing capabilities, RoosterBio and Thermo Fisher are positioned to accelerate the development of next-generation therapies for degenerative diseases, potentially transforming treatment options for patients worldwide.
