Novartis announced the opening of a new 10,000-square-feet radioligand therapy (RLT) manufacturing facility in Carlsbad, California. This state-of-the-art site represents a key milestone in the company’s previously announced USD 23 billion investment in US infrastructure over the next five years.

The opening of the Carlsbad manufacturing facility allows Novartis to meet future demand for RLT, adding additional capacity and augmenting the company’s world-class supply chain capabilities. The Carlsbad facility has been filed with the FDA as an additional US point of supply, and commercial manufacturing may begin once approval is granted.

RLTs are a form of precision medicine that combines a tumour-targeting molecule (ligand) with a therapeutic radioisotope, enabling the delivery of radiation to the tumour with the goal of limiting damage to the surrounding cells. Because each RLT dose is custom-made and time-sensitive, with a radioactive half-life measured in hours, proximity to treatment centres and transit hubs helps ensure patients receive their treatment when and where they need it.

“At Novartis, we tackle the toughest challenges in medicine by doing what’s never been done before for patients. 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 opening of our Carlsbad facility underscores our strong commitment to the US and dedication to bringing this pioneering treatment to patients across the country,” said Vas Narasimhan, CEO, Novartis.

Novartis is the only pharmaceutical company with a dedicated commercial RLT portfolio, and the Carlsbad facility is its third US RLT manufacturing site, reinforcing its global leadership in radioligand therapies with unmatched expertise in development, production, and delivery to patients worldwide. The Carlsbad facility is purpose-built to manufacture the company’s FDA-approved RLTs with capacity for future expansion.

“We commend Novartis for supporting our broader mission of bringing manufacturing capacity in the United States. Our unique partnership approach is working,” said Marty Makary, M.D., M.P.H, Commissioner, FDA.

“Novartis is transforming the future of cancer care—and it's happening right here in Carlsbad. 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. I'm proud our local community will be part of the future of cancer care,” said Melanie Burkholder, City Council Member, Carlsbad.

In addition to the Carlsbad facility opening, Novartis has outlined several construction and expansion initiatives across the United States. The company plans to build two additional radioligand therapy (RLT) manufacturing facilities in Florida and Texas, while also expanding its existing sites in Durham, North Carolina; Indianapolis, Indiana; and Millburn, New Jersey. Furthermore, Novartis will establish its second global R&D hub in the US with a new state-of-the-art biomedical research innovation centre in San Diego, California, reinforcing its long-term commitment to advancing radioligand and biomedical innovation.

These investments, enabled by a pro-innovation policy and regulatory environment in the US, reflect Novartis's broad commitment to the market and building its infrastructure. The company expects to invest nearly USD 50 billion in its US operations over the next five years, including the USD 23 billion announced earlier this year, underscoring its long-term commitment to strengthening the US healthcare ecosystem.