Center for Theranostics Advancement: Building the Future of Precision Medicine in Indianapolis
In the heart of Indianapolis, Indiana, the Center for Theranostics Advancement (CTA) is emerging as a hub for innovation in one of the most promising areas of modern healthcare: radiopharmaceuticals. On this bustling campus, scientists, innovators, and manufacturers are working side by side to develop theranostic radiopharmaceutical products—drugs that not only diagnose but also treat diseases. These therapies, which link radioactive isotopes to targeting molecules that hone in on diseased tissue, are redefining how precision medicine is delivered to patients.
Theranostics are designed with a precision-first mindset, offering targeted treatment that can be tailored to the biological profile of each patient’s disease. They hold promise across multiple therapeutic areas, including cancer, cardiovascular conditions, and neurological disorders. By combining diagnosis and therapy in a single approach, they represent the kind of innovation that can change patient outcomes and healthcare systems alike.
From Concept to Commercial Scale: The Role of CTA
At the center of this effort is Cardinal Health’s Nuclear & Precision Health Solutions (NPHS) business, which oversees the CTA and its growing ecosystem of facilities. Among the most recent additions is the Commercial Manufacturing Center (CMC), a facility purpose-built to bridge the gap between early-phase development and large-scale commercial production.
According to Shane Thrasher, NPHS’ vice president of nuclear manufacturing, the CMC plays a critical role in translating early innovations into products that reach patients:
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,” Thrasher explained.
This end-to-end support ensures that innovators in the theranostics field have a partner capable of guiding them through the entire product lifecycle—from feasibility studies to commercial distribution.
Why Theranostics Are Transforming Healthcare
The promise of theranostics lies in their ability to detect diseases earlier and deliver treatments that minimize collateral damage to healthy tissues. Traditional therapies like chemotherapy or radiation often affect healthy cells along with diseased ones, but theranostics are built to reduce that risk by targeting diseased tissue more precisely.
This precision is not only expected to improve patient outcomes—by extending life expectancy or enhancing quality of life—but also to transform how diseases are managed over time.
The demand for theranostic therapies is growing rapidly. According to BCC Research, the global theranostics market, valued at $4.3 billion in 2024, is projected to more than triple to $12.7 billion by 2029. This surge reflects both the rising prevalence of chronic diseases and the recognition of theranostics as a promising new frontier in care.
CTA is preparing to meet this demand. Thrasher noted that his team is actively monitoring about 60 high-probability theranostic innovations. If even a fraction of these prove viable, CTA is ready to provide the infrastructure and expertise to bring them to market quickly.
Why Indianapolis?
The decision to locate the CTA in Indianapolis was strategic. Several factors make the region uniquely suited to support the radiopharmaceutical industry:
- Proximity to Population Centers: From Indianapolis, CTA can reach most of the major U.S. population hubs within 24 hours, which is critical given the short shelf-life of many radiopharmaceutical products.
- Logistics Advantage: The presence of one of the world’s largest courier hubs ensures global connectivity and rapid delivery timelines.
- Skilled Workforce: Indiana’s strong pharmaceutical manufacturing base provides access to an experienced talent pool with relevant expertise in drug development and production.
These advantages make Indianapolis not just a manufacturing base but also a strategic gateway for distributing life-saving therapies.
Inside the CTA: A Three-Tiered Ecosystem
The CTA encompasses three key facilities, each playing a distinct role in the lifecycle of a radiopharmaceutical:
- The Innovation Center – This is where new ideas take root. Innovators and scientists collaborate to develop novel radiopharmaceutical products, design early-stage clinical trials, and determine appropriate dose ranges and schedules for administration.
- The Pre-Commercial Manufacturing Center – As therapies advance, they move to this facility, where larger quantities are produced to support mid- and late-stage clinical trials. The focus here is on demonstrating efficacy in real-world patient populations.
- The Commercial Manufacturing Center (CMC) – At this state-of-the-art, 60,000-square-foot facility, therapies that achieve regulatory approval are produced at scale. With 28,000 square feet of modular manufacturing suites, the CMC can flexibly adapt to a wide range of manufacturing needs. Multiple suites can run simultaneously, enabling the production of different products in parallel.
This tiered approach ensures continuity from concept through commercialization, reducing barriers that often delay therapies from reaching patients.
Meeting the Highest Standards
In the United States, radiopharmaceuticals fall under the dual oversight of the Food and Drug Administration (FDA) and the Nuclear Regulatory Commission (NRC). These agencies set stringent requirements to ensure both safety and efficacy, as well as compliance with radiation handling protocols.
The CTA operates under Good Manufacturing Practices (GMP), which dictate rigorous standards for everything from facility design and equipment calibration to staff training and environmental control. Every step—from raw material sourcing to final product testing—is documented and quality-assured.
This ensures that every radiopharmaceutical manufactured at CTA meets the highest safety and consistency benchmarks before it ever reaches a patient.
The NPHS Nuclear Pharmacy Network
Once products leave CTA’s manufacturing floor, they enter a vast NPHS distribution network. This includes:
- 130 nuclear pharmacies that prepare millions of unit doses annually.
- 30 PET cyclotron facilities that manufacture radioactive isotopes for diagnostic imaging.
Because radiopharmaceuticals decay rapidly—sometimes within just hours—distribution must be precise and immediate. Products are often delivered first to central pharmacies in Indianapolis, East Rutherford (New Jersey), and Denver, where patient-specific doses are prepared. From there, they are rushed to hospitals and clinics, often hand-delivered within hours.
Remarkably, this time-sensitive system operates with a 99.8% success rate, ensuring that doses arrive on time despite the inherent logistical challenges.
Spotlight on Actinium-225: A Game-Changer in Cancer Therapy
Among the most exciting breakthroughs at the CMC is the large-scale production of actinium-225 (Ac-225), a rare alpha-emitting isotope that shows enormous potential in oncology. When bound to molecules such as peptides or antibodies, Ac-225 can deliver targeted alpha therapies (TATs) that kill cancer cells while sparing healthy tissue.
With a 10-day half-life, Ac-225 is ideally suited for circulation in the body and delivery to targeted sites. Already, it is being tested in clinical trials for some of the most prevalent cancers, including prostate, neuroendocrine, breast, and colon cancers.
Until recently, global supply of Ac-225 was extremely limited. But a collaboration between Cardinal Health and TerraPower Isotopes has dramatically increased production capacity, enabling pharmaceutical innovators worldwide to pursue new therapies.
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,” said Thrasher.
This development positions CTA as a global leader in making next-generation cancer therapies a reality.
