Swiss pharmaceutical giant Novartis has opened a new 10,000-square-foot radioligand therapy (RLT) manufacturing facility in Carlsbad, California, representing a significant milestone in the company's $23 billion US infrastructure investment plan announced earlier this year.
The state-of-the-art facility marks Novartis' third US-based RLT manufacturing site and is designed to produce precision cancer treatments that combine tumor-targeting molecules with therapeutic radioisotopes. These specialized drugs deliver radiation directly to tumors while limiting damage to surrounding healthy cells.
Strategic Manufacturing Expansion
The Carlsbad facility addresses the unique challenges of RLT production, where each dose is custom-made and time-sensitive with a radioactive half-life measured in hours. This proximity to treatment centers and transit hubs ensures patients across the western United States, Alaska, and Hawaii receive their treatments when and where needed, maintaining Novartis' delivery rate of greater than 99.9%.
"At Novartis, we tackle the toughest challenges in medicine by doing what's never been done before for patients," said Vas Narasimhan, CEO of Novartis. "Radioligand therapy is a breakthrough we've unlocked at scale, made possible by reimagining how innovation reaches patients. As the global leader in RLT for more than seven years, we've advanced this technology with a deep belief in its power to transform cancer care."
The facility has been filed with the FDA as an additional US point of supply, with commercial manufacturing set to begin once regulatory approval is granted.
Market Leadership in Radioligand Therapy
Novartis stands as the only pharmaceutical company with a dedicated commercial RLT portfolio, currently marketing Pluvicto for prostate cancer and Lutathera for rare gastrointestinal tumors. The company has established global expertise with specialized supply chain and manufacturing capabilities across its network of RLT production sites worldwide.
The company is actively investigating RLT applications across multiple cancer types, including prostate, breast, colon, lung, brain, and pancreatic cancers, maintaining one of the deepest and most advanced pipelines in the industry.
Broader US Investment Strategy
The Carlsbad opening is part of Novartis' comprehensive US expansion plan, which includes multiple construction initiatives:
- Two additional RLT manufacturing facilities planned for Florida and Texas
- Expansion of existing sites in Durham, North Carolina; Indianapolis, Indiana; and Millburn, New Jersey
- A new state-of-the-art biomedical research innovation facility in San Diego, California, establishing the company's second global R&D hub in the US
FDA Commissioner Marty Makary praised the investment, stating, "We commend Novartis for supporting our broader mission of bringing manufacturing capacity in the United States. Our unique partnership approach is working."
Economic and Community Impact
Carlsbad City Council Member Melanie Burkholder highlighted the facility's significance for the region: "This new advanced RLT production facility is a major milestone for our region, strengthening California's position as a hub for life sciences innovation. It will bring exciting new opportunities for our community, including more engineering and manufacturing jobs."
Novartis expects to invest nearly $50 billion in its US operations over the next five years, including the $23 billion infrastructure commitment announced in April. This investment strategy was developed partly in response to renewed threats of drug import duties from the Trump administration, demonstrating the company's long-term commitment to strengthening the US healthcare ecosystem.
The facility is purpose-built to manufacture the company's FDA-approved RLTs with capacity for future expansion, positioning Novartis to meet growing demand for these precision cancer treatments while maintaining its leadership position in the radioligand therapy market.
