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GMP compliant facility has clinical and commercial manufacturing capabilities to support the company's growing pipeline of targeted alpha therapies (TATs).
May 2, 2023
By: Anthony Vecchione
Fusion Pharmaceuticals Inc., a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, opened its state-of-the-art radiopharmaceutical manufacturing facility. The 27,000 sq.-ft. GMP compliant facility, located adjacent to the company’s R&D labs, has clinical and commercial manufacturing scale capabilities designed to support the Company’s growing pipeline of targeted alpha therapies (TATs). “Manufacturing and supply chain are critical components of radiopharmaceutical development and commercialization,” said John Valliant, CEO Fusion. “Having spun out of a radiopharmaceutical manufacturer, this is a core competency for Fusion, and we believe we are well-positioned to scale production in support of our pipeline of TATs, which now includes five clinical-stage programs. The location of the facility, adjacent to both our internal research organization and McMaster University, a world-class institution that specializes in medical isotope research and training, enables us to efficiently advance new TATs and hire experienced talent to execute on our clinical and future commercial plans.” The new manufacturing facility, part of a 15-year lease agreement with Hamilton, Ontario-based McMaster University, was built by McMaster and equipped and validated by Fusion. At full capacity, it is expected to produce more than 100,000 doses of TATs per year. Fusion Pharmaceuticals is a spin out company of the Centre for Probe Development and Commercialization (CPDC) hosted at McMaster and founded by Valliant. “McMaster University is a pioneer in medical isotope research and the McMaster Innovation Park is the ideal location to produce the next generation radiopharmaceuticals for cancer therapy,” said David Farrar, president of McMaster University. “We’re proud to expand on our partnership with Fusion –– and to grow our region’s biotechnology and biomanufacturing sector.” To ensure scalability and redundancy, Fusion plans to continue to leverage existing contract development and manufacturing organization (CDMO) relationships with Cardinal Health, SpectronRx, Radiomedix and AtomVie. “With the complexity of just-in-time manufacturing for radiopharmaceuticals, diversification in supply chain and redundancy in production is vital to ensuring reliable patient access to therapy,” said Fusion chief technology officer Eric Burak. “Coupled with our previous investments in actinium supply, this new facility provides further control for our entire supply chain to meet the growing patient demand for targeted alpha therapies.”
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