NorthStar completes cleanroom build at Beloit facility

NorthStar Medical Radioisotopes has finished building specialized facilities at its Beloit location as it prepares to ramp up manufacturing. 

The commercial-stage radiopharmaceutical business recently announced the “critical milestone,” noting the new space will support current clinical trials and “full-scale manufacturing” that’s slated to begin in July. 

NorthStar is developing radioisotopes, or radioactive forms of certain elements, that can be used in the detection and treatment of cancer and other diseases. That includes copper-67, which can kill cancer cells as part of precision therapies. 

And it’s preparing to be the first commercial-scale producer of non-carrier added actinium-225, another potential cancer treatment material that doesn’t occur in nature, according to the release.

Company President and CEO Frank Scholz says NorthStar is “uniquely equipped” to help companies overcome the challenge of finding a reliable supply of radiopharmaceuticals for both clinical trials and treating patients. 

“NorthStar’s vertically integrated manufacturing offers our partners significant manufacturing, supply chain and environmental advantages, including simplified logistics with minimal shipping requirements, efficient utilization of the radioisotope and a reduced carbon footprint,” he said in a statement. 

The cleanroom includes multiple shielded enclosures for biological materials and preparing radioactive drug products; a solution preparation area for weighing, adjusting or dissolving components; and a controlled entry space separating the cleanroom environment from the rest of the building, similar to an airlock. 

The company says these assets will help facilitate the “various complex stages of drug development,” from clinical trials and regulatory review to commercialization. That includes the “tech transfer” process, which scales up from research-level lab quantities to larger-scale commercial production. 

Along with those additions, NorthStar also plans to open a 52,000-square-foot custom contract development and manufacturing organization, or CDMO, facility later this year. The company says that space will further expand its capabilities, with a production launch planned for early 2025. 

See the release and more details.

See an earlier story on the company.