NorthStar Medical Radioisotopes, LLC, a global innovator in the development, production and commercialization of radiopharmaceuticals used for therapeutic applications and medical imaging, today announced a significant expansion of its business platform with the formation of a new, patient-focused Radiopharmaceutical Contract Development and Manufacturing Organization (CDMO) services unit. Based on the success of its diagnostic imaging and therapeutic radioisotope production programs, NorthStar has created the services unit to further advance development and commercialization of radiopharmaceuticals to treat patients who have cancer and other serious diseases. The CDMO will provide collaborator companies with a full range of customized radiopharmaceutical development and commercialization services, and serve NorthStar in progressing its own radiopharmaceutical programs. Ground has been broken on a new facility, located alongside production facilities on the Company’s Beloit, Wis. campus. Upon completion, NorthStar will be the first and only U.S. company housing commercial-scale, multi-radioisotope production and radiopharmaceutical development services on the same campus, enabling collaborator companies to realize logistical, regulatory and cost benefits.
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NorthStar Medical Radioisotopes’ Radiopharmaceutical CDMO in Beloit, Wis. (artist rendering). Upon completion, NorthStar will be first and only U.S. company housing commercial-scale, multi-radioisotope production and radiopharmaceutical development services on the same campus, enabling collaborating companies to realize logistical, regulatory and cost benefits. (Photo: Business Wire)
“Establishing this new radiopharmaceutical CDMO services unit at NorthStar marks an important inflection point in our growth plan to facilitate efficient patient supply of game-changing radiopharmaceuticals,” said Stephen Merrick, Chief Executive Officer of NorthStar Medical Radioisotopes. “NorthStar’s industry-leading reputation is grounded in technological innovation, successful execution and proven expertise. Our track record of success includes production and expanded capacity of U.S.-produced, non-uranium based molybdenum-99 (Mo-99) for use in diagnostic imaging. We are poised to be the first commercial-scale producer of non-carrier added (n.c.a.) therapeutic radioisotopes actinium-225 (Ac-225) and copper-67 (Cu-67) using advanced, environmentally preferable electron accelerator technology. With our depth and breadth of technical knowledge in the development and production of medical radioisotopes, we are now expanding to help companies progress their own radiopharmaceutical development programs. NorthStar’s CDMO will enable us to share our radiopharmaceutical development and commercialization expertise with pharmaceutical or biotechnology companies that may require additional infrastructure, resources or the specialized knowledge required for complex radiopharmaceutical development, to help them develop and deliver products with the potential to improve care for even more patients with serious disease.”
“We are excited that NorthStar will be able to offer a full spectrum of radiopharmaceutical CDMO services to facilitate the radiopharmaceutical drug development process,” said Frank Scholz, Ph.D., President and Chief Operating Officer of NorthStar Medical Radioisotopes. “We plan to collaborate with pharmaceutical and biotechnology companies to provide customized input and support across all phases of program development, from early stage through commercialization and product life cycle management. NorthStar’s radiopharmaceutical CDMO services will be customized to accommodate each customer’s needs and in compliance with rigorous regulations and attention to safety. They will include radionuclide procurement and formulation, dedicated suites for compounding and filling operations, quality assurance and quality control, analytical services, regulatory support, scale-up and commercialization activities and logistical support with packaging and shipping. NorthStar’s highly talented workforce possesses the specialized expertise to help support our radiopharmaceutical CDMO activities, and we plan to hire additional employees in association with this expansion. We have begun design, construction and fitting-out of clean rooms, laboratories and other required infrastructure for the dedicated 36,000 square foot facility, and expect that it should be available to deliver services in late 2024, pending appropriate licensure and regulatory approvals.”
About NorthStar Medical Radioisotopes, LLC
NorthStar Medical Radioisotopes is a commercial-stage nuclear medicine company focused on advancing patient care by providing diagnostic and therapeutic radioisotopes, novel radiopharmaceuticals and customized radiopharmaceutical development services. Its proven management team and state-of-the-art, environmentally preferable and non-uranium based technologies have made it an emerging leader at the forefront of U.S. medical radioisotope and radiopharmaceutical production. NorthStar is the sole domestic producer of molybdenum-99 (Mo-99), used to generate the standard-of-care diagnostic imaging radioisotope for assessing heart disease and cancer. It is expanding its industry-leading position in the growing area of therapeutic radioisotopes, used in targeted radiopharmaceutical therapy to treat cancer and other serious diseases, and is poised to be the first commercial-scale producer of non-carrier added (n.c.a.) actinium-225 (Ac-225) and copper-67 (Cu-67). NorthStar’s Radiopharmacuetical Contract Development and Manufacturing Organization (CMDO) unit will provide customized service offerings and specialized radiopharmaceutical expertise to help biopharmaceutical companies rapidly advance their development and commercialization programs.
