The Center for Theranostics Advancement (CTA) in Indianapolis, Indiana, is a bustling campus, with dozens of innovators, scientists, and manufacturers developing theranostic radiopharmaceutical products, drugs which can be used to diagnose and/or treat neurological and cardiovascular disorders, cancer, and many other diseases. These products contain radioactive isotopes linked to targeting molecules that direct them to specific tissues within the body. Theranostics are often tailored to the specific profile of a disease, enabling a precision medicine approach for patients.
The Commercial Manufacturing Center (CMC) is one of the newest facilities within Cardinal Health’s Nuclear & Precision Health Solutions (NPHS) CTA business. The facility adds to the foundational commercial expertise of NPHS, connecting the earlier phases of drug development performed within the CTA, and supporting the entire product lifecycle, from development and early feasibility studies, through to commercial manufacturing at scale.
“What we can do here is of great value to our innovator customers,” said Shane Thrasher, NPHS’ vice president of nuclear manufacturing, who leads the work at the CMC. “We start with an innovator’s idea, take it through testing and development, manufacture it at scale, then get it to providers and their patients through our extensive nuclear pharmacy network.”
Theranostics: A growing industry
Theranostics offer the promise of earlier disease detection, targeted treatments that may be less likely to harm healthy tissues than traditional treatments (like radiation or chemotherapy, for example), and potentially offering better outcomes – which may be seen in extending patients’ life span or quality of life.
“Because of their promise, and due to the growing prevalence of chronic diseases, there is a great demand for theranostics,” Thrasher said. In fact, the global theranostics market is expected to grow from $4.3 billion (as of late in 2024), to $12.7 billion by the end of 2029, according to BCC Research.
“We keep up with the rapidly growing demand by being nimble and fast,” Thrasher said. “We’re currently tracking about 60 high-probability theranostics innovations. If any of these prove viable, we are prepared to help their innovators bring them to market.”
The CTA was built in Indianapolis because this region is well located to support the radiopharmaceutical industry. From here, it is possible to reach all of the most highly populated areas of the U.S. within 24 hours. In addition, one of the world’s largest courier hubs is here, which allows products to be shipped with speed all over the world. And finally, the large pharmaceutical manufacturing footprint in the area means a strong, experienced workforce with relevant expertise.
Inside the Center for Theranostics Advancement
In the U.S., the radiopharmaceutical industry is regulated by both the Food and Drug Administration (FDA), which evaluates the safety, efficacy and quality of drug and biological products, and the Nuclear Regulatory Commission (NRC), which ensures that the facilities that handle radiopharmaceuticals are licensed and adhere to radiation safety protocols.
Radiopharmaceuticals must meet strict quality and manufacturing standards to ensure consistent and safe production. The CTA meets Good Manufacturing Practices (GMP) regulations, which detail the necessary procedures for high quality radiopharmaceutical manufacturing. GMPs guide quality assurance, facility design and environmental control, training for staff, equipment and its calibration to help ensure consistent performance, and documentation of every process, from raw material sourcing to each step of production and testing.
The CTA includes three facilities:
The NPHS nuclear pharmacy network
Once manufactured products have been independently reviewed by on-site quality assurance staff, they are released for distribution through our network, which includes 130 nuclear pharmacies that prepare and deliver millions of unit-doses of radiopharmaceuticals every year. (The network also includes 30 PET cyclotron manufacturing facilities, which produce radioactive isotopes for PET imaging that aid in the diagnosis and monitoring of various diseases.)
“This network is the core of the NPHS business, and it’s really what makes our work at the CTA possible,” Thrasher said. “All of our products have a short half-life, meaning the time it takes for half of the radioactive nuclei to decay. The half-life may be several days or several hours; there is no time to lose in delivering these radiopharmaceutical products to providers. Products manufactured at the CTA are often delivered to one of three central pharmacies (Indianapolis, Indiana; East Rutherford, New Jersey; and Denver, Colorado), and they, in turn, prepare patient-specific doses that are delivered directly to a specific location within a health system’s department. Other doses are delivered to one of our many regional facilities, which provide white glove delivery of the doses to the healthcare provider. Our team of nuclear pharmacists works day and night to get our products to patients on time – and they succeed 99.8% of the time.”
Manufacturing actinium-225
One of the most exciting new developments at the CMC facility is the at-scale production of the therapeutic isotope actinium-225 (Ac-225), which began late last year in collaboration with TerraPower Isotopes. Ac-225 is a rare, alpha-emitting radionuclide that can be attached to small molecules, peptides or antibodies. The resulting targeted alpha therapies (TATs) intend to deliver Ac-225 directly to diseased tissues, potentially killing those cells without damaging any nearby healthy tissues.
Ac-225 has a half-life of just 10 days – long enough for it to be incorporated in a radiopharmaceutical that has time to circulate in the human body and hit targeted areas. Because it is seen as a promising new weapon in the fight against cancer, Ac-225 is in very high demand. It is currently being tested in TATs that are part of worldwide clinical studies, to evaluate safety and efficacy in treating some of the most commonly diagnosed cancers, including prostate, neuroendocrine, breast and colon cancers.
TerraPower Isotopes, in cooperation with Cardinal Health, has developed a process to produce Ac-225 in much greater quantities than were possible in the past. Ac-225 is being utilized for development by pharmaceutical innovators worldwide – paving the way for the future commercial manufacturing of novel therapies that will help advance patient care.
“We’re really proud of this collaboration with TerraPower, and how it will allow us to aid in the manufacturing of Ac-225 for pharmaceutical manufacturers around the globe,” Thrasher said.
What’s next for the Center for Theranostics Advancement
Thrasher expects that the large-scale manufacturing facility of the CTA will be running at full capacity in the next two to three years, with clean room manufacturing suites supporting up to a dozen different customers.
“There’s so much potential in theranostics to transform healthcare, for providers and patients,” he said. “It’s a very exciting space to work in.” Thrasher, whose entire career has been devoted to pharmaceutical manufacturing, said he’s energized by the potential of precision medicine.
“Every day, we come to work knowing that what we do is positively impacting patients’ lives. We have no shortage of inspiration; it’s just very, very motivating.”