Radiopharmaceutical CDMO, NorthStar Medical, has inaugurated a 52,000-square-foot Radiopharmaceutical CDMO facility in Beloit, Wisconsin, to become the only U.S.-based company housing commercial scale radioisotope production and CDMO services at the same facility.

The new facility will develop and manufacture key medical radioisotopes - including Ac-225, Lu-177, Cu-64, Cu-67, and In-111 - as the company plans to support biopharmaceutical companies in advancing diagnostic and therapeutic radiopharmaceuticals, particularly for cancer treatment.

NorthStar Medical Radioisotopes, LLC, a global innovator in the development, production and commercialization of radiopharmaceuticals used for therapeutic applications and medical imaging hosted a grand opening event and ribbon-cutting at the state-of-the-art NorthStar Dose Manufacturing Center in Beloit, Wis., on October 3, 2024. Guest speakers joined with other industry and healthcare leaders, NorthStar customers, suppliers, and partners to share perspectives on the exciting growth of nuclear medicine, the need for reliable U.S. radioisotope supply to support better patient outcomes and how NorthStar is critical to this success.

Guest speakers included:

• Philip Kantoff, MD, CEO and Founder, Convergent Therapeutics

• Shaemus Gleason, Executive Vice President, Clarity Pharmaceuticals

• Diane M. Hendricks, Chairperson, Hendricks Holding Co., Inc.

NorthStar’s additional facility will play a critical role in the advancement of diagnostic and therapeutic radiopharmaceuticals as the capacity will lead to further options for biopharmaceutical and pharmaceutical companies, and will provide them with customized solutions to help navigate the complexities of radioisotope research, development and manufacturing. The purpose-built design will add much needed capacity to the industry, and will allow for NorthStar to continue to add more services to meet the demand and regulatory guidelines of customers around the world.

“NorthStar has evolved from a one product isotope manufacturer to a company prepared to develop, produce, process and ship a board range of varied pharmaceuticals from one single vertically integrated campus”, said Frank Scholz, President and Chief Executive Officer of NorthStar Medical Radioisotopes. “Important clinical studies are underway using Actinium-225 (Ac-225) and Copper-67 (Cu-67) in patients with various types of cancers, including prostate, lung, breast, colon, lymphoma and neuroendocrine tumors. NorthStar is proud to be at the forefront of making these promising radiopharmaceutical therapies a reality.”

“Our mission is to provide patients with global access to game-changing radiopharmaceuticals. And in doing so, helping to reimagine cancer therapy by producing radioisotopes for the treatment of cancer and other serious diseases. We are applying our experience and expertise to help develop novel radiopharmaceuticals. The unique characteristics and requirements, along with the specialized facilities, processes, equipment, technology and talent know-how that it takes to develop and manufacture radiopharmaceuticals means in most cases, the biopharmaceutical companies designing these agents don’t have the specialized skills or processes necessary to deliver these medicines, particularly when they are still in clinical trials. These companies understand that it is not realistic or financially viable to do it themselves. That is where NorthStar rises above the rest.”

Dr. Scholz continued, “With passion and strong dedication to the radiopharmaceutical industry, our entire campus has been purpose built. It was designed with a focus on redundancy, reliability, quality, scalability, and safety. We will be capable of expanding production as our customer needs increase. NorthStar is already routinely producing the therapeutic radioisotope Cu-67, and later this year, we will become one of the first producers of Ac-225. In addition, this state-of-the-art facility will support all phases of the pharmaceutical life cycle for critical medical radioisotopes, including Ac-225, Lu-177, Cu-64, Cu-67, In-111, amongst others, from research and development, clinical phase manufacturing, through to commercial manufacturing.”

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