Our
Facilities

NorthStar’s corporate headquarters in Beloit house our executive, administrative, QA/Regulatory, logistics, production activities for the RadioGenix^® System (technetium Tc 99m generator) and associated consumables, source vessel reprocessing and assembly, customer care, field service engineering and training teams.

This 20,000 ft² facility was completed in September 2019, with equipment installation nearing completion. Once fully qualified and approved by regulatory authorities, this facility will house a state-of-the art Radiation Laboratory, multiple dissolution and filling hot cells, and automated packaging and shipping lines to support dissolution, filling, and shipment of Mo-99 source vessels. A novel cMo-98, aMo-100 reclamation facility is also being installed.

Ground breaking for this 30,000 ft² building was celebrated in September 2019. The first pair of electron beam accelerators have been successfully installed.

Production of molybdenum-99 (Mo-99):

NorthStar estimates that electron accelerator technology will increase its Mo-99 program production capability to meet nearly 40% of U.S. demand. The Accelerator Production facility is expected to come online, upon completion of regulatory submissions, in late 2023.

Production of copper-67 (Cu-67):

NorthStar’s unique and proprietary electron accelerator production facility and processes are designed to provide efficiencies throughout the production process, thereby enabling the production of multiple radioisotopes utilizing the same equipment. With this in mind, we expect commercial production of Copper-67 (Cu-67) to start in June, 2023.

Up to three additional mirror-image accelerator facilities are planned to support increased market demand for Mo-99, Cu-67, and other radioisotopes.

Groundbreaking for this 28,000+ ft² (with the ability to add 14,000 ft² at a later date) first-of-its-kind Actinium-225 (Ac-225) Production facility, dedicated exclusively to commercial-scale production of non-carrier added (n.c.a.) Ac-225 was celebrated in September 2021. The facility will house a Rhodotron® TT300 HE electron-beam accelerator used solely for the production of Ac-225. This marks the third electron accelerator NorthStar has purchased from IBA and will build upon expertise gained from our completed Accelerator Production facility that will be used for the production of molybdenum-99 (Mo-99) and other radioisotopes once appropriate approvals are received.

Orders were placed for the electron accelerator and essential long-lead items in November 2021. In parallel, plans are being finalized for both building design and the systems required to support commercial production of n.c.a. Ac-225. Utilizing design concepts and key learnings from our Mo-99 Accelerator Production facility will allow for more efficient and expedited completion timelines, with potential future expansion plans in mind.

Construction began in early 2022 with initial production of radiochemical grade Ac-225 planned for 2024. We expect submission of the Drug Master File to the U.S. Food and Drug Administration (U.S. FDA) in 2025.

NorthStar Medical Radioisotopes will be the first and only U.S. company housing commercial-scale, multi-radioisotope production and radiopharmaceutical development services on one campus. Our new Radiopharmaceutical CDMO facility will be part of our 55-acre campus in Beloit, Wisconsin, enabling collaborator companies to realize the logistical, regulatory and other efficiency benefits afforded by a single site location.

Groundbreaking for the new 52,000 square foot, state-of-the-art Radiopharmaceutical CDMO facility occurred in November 2022. The facility is purpose-engineered to meet growing demands for therapeutic and diagnostic radiopharmaceuticals. Also designed with the needs of our partner companies in mind, the facility will offer the flexibility needed to support advancement of their products, from development to commercialization.

NorthStar’s 55-acre Beloit campus has space for additional facilities that will support the production of other isotopes and related products as their development progresses.