SpectronRx, a radiopharmaceutical contract development and manufacturing organization (rCDMO), announced that initial construction of its Bunker Hill, IN, medical isotope production facility has been completed and two new cyclotrons have been installed.

In addition, as part of its ongoing development and testing, SpectronRx was able to produce low amounts of Actinium-225 (Ac-225) by irradiating targets on a cyclotron, processing the targets containing Ac-225 and performing the necessary analytical testing to demonstrate the presence of Ac-225. 

“This is not only a major milestone for the team at SpectronRx, but it’s also an important achievement for patients and healthcare providers alike,” said John Zehner, CEO of SpectronRx. “As new advances in radiopharmaceutical development continue to improve the diagnosis and treatment of certain diseases, demand for medical isotopes like Ac-225 is increasing. And to avoid shortages of these vital elements, it is critical that sufficient supplies are in place.”

In addition to being utilized for the detection and treatment of certain diseases like heart disease, thyroid disease, arthritis and Alzheimer, isotopes such as Ac-225 are also proving to be exceptional cancer fighters.

The company said that when attached to a molecule, isotope-powered radiopharmaceuticals can selectively target cancer sites and destroy cancerous tissue with minimum damage to healthy cells. They can even keep cancer cells from replicating, killing them altogether. Unfortunately, only small amounts of isotopes like Ac-225 are produced by various government entities.

To enhance the available supply of medical isotopes, SpectronRx purchased a 10-acre site near Grissom Air Reserve Base in late 2021. The completed Bunker Hill isotope production facility now features two interconnected buildings totaling 20,000 sq. ft. and two cyclotrons. The company has initiated the acquisition of an additional 18,000 sq. ft. at the site and will install more cyclotrons once development is finalized. The multimillion-dollar project is expected to take 18 more months to complete.

Christopher Ritter, vice president of Isotope Production at SpectronRx said: “Through the initial testing of our new cyclotrons, we have achieved a major breakthrough in isotope development by producing Ac-225. Our next goal is to have more than 25 professionals working hand-in-hand with pharmaceutical companies and healthcare professionals from across the U.S. to produce this life-saving medical isotope and others to help fuel some of the most advanced medical treatments in the world. This is an exciting time, and we are proud that Indiana is becoming the epicenter of radiopharmaceutical development.”

SpectronRx possesses a U.S. Nuclear Regulatory Commission (NRC) materials license that authorizes the company to receive, acquire, possess and transfer byproduct, source, and special nuclear material in any chemical and/or physical form. The current license lists more than 25 different isotopes. Authorized uses include the preparation and distribution of radioactive drugs and radio chemicals for medical use to authorized recipients, including chemical synthesis, radioiodination and redistribution of used and unused generators.

The company has more than 100 employees across four locations and provides services to organizations on six continents. The company works routinely with pharmaceutical and healthcare organizations throughout the U.S., in select European countries and in Asia, where it supplies isotopes to Japan. SpectronRx’s domestic operations include four locations, a 36,000 sq. ft. facility in South Bend, a 60,000 sq. ft. facility in Indianapolis, the new 20,000 sq. ft. facility in Bunker Hill and a soon-to-be-announced location in Connecticut.