Novartis expands its radioligand manufacturing network

Two additions to US production

Novartis is extending its radioligand therapy manufacturing network with a new radioisotope-production facility at its Indianapolis site and a third US manufacturing location in Carlsbad, California. The Indianapolis expansion has broken ground. The California project is intended to improve supply-network resilience and delivery to patients on the West Coast.

Both additions are designed with space for further expansion, potentially accommodating different isotopes, ligands and therapies. Their future contribution to supply remains conditional on completion and approval. The construction programme adds isotope production alongside the existing manufacturing operations in Indianapolis.

Novartis

An earlier commercial-manufacturing approval

The existing Indianapolis facility received US Food and Drug Administration approval for commercial manufacturing of Pluvicto on 5th January 2024. The 70,000-square-foot site became Novartis's second US radioligand manufacturing location. It was purpose-built with room for additional production lines, including planned fully automated lines.

The January manufacturing expansion brought the company's stated radioligand production capacity to 250,000 doses for 2024 and beyond across four active sites. This figure covered the network rather than the Indianapolis plant alone.

Indianapolis and Millburn, New Jersey: US supply.
Ivrea, Italy: supply within and outside the US.
Zaragoza, Spain: supply outside the US.

Future Canadian supply from Indianapolis remained subject to approval.

Research and clinical-supply infrastructure

Novartis also entered an agreement to acquire Mariana Oncology on 2nd May 2024. The preclinical biotechnology company, based in Watertown, Massachusetts, would add research infrastructure and clinical-supply capabilities alongside a portfolio of radioligand programmes, ranging from lead optimisation to early development.

The agreed financial terms comprised a USD 1 billion upfront payment and a further USD 750 million tied to pre-specified milestones. The acquisition agreement was subject to customary closing conditions when announced; the conditional payments were separate from the upfront consideration.

Mariana's portfolio included MC-339, an actinium-based development candidate being investigated for small cell lung cancer. The programmes also covered breast and prostate cancer research. These were development activities, with regulatory approval and future commercial success remaining uncertain.