The Switzerland-based firm is establishing its third RLT-focused facility in the US in Carlsbad, California, to go along with its existing sites in Millburn, New Jersey, and Indianapolis, Indiana. According to the firm, the 10,000 square-foot facility is being built within an existing Novartis location and is designed with extra space to accommodate future expansion.
Meanwhile, the firm is also expanding its Indianapolis site by building a facility to produce radioactive isotopes, which are critical in RLT production. The firm confirmed that this will be the first Novartis-owned isotope production site in the US. The company expects to complete its qualifications and subsequent regulatory approvals by 2026.
“Isotopes produced at the new nearly 80,000 square-foot Indianapolis facility will be used in RLTs at Novartis RLT manufacturing facilities across the US and provide supply-chain resiliency to enable ample isotope supply in both the US and other parts of the world,” a spokesperson for Novartis told BioProcess Insider.
“Additionally, our Carlsbad facility will bolster supply of RLTs along the West Coast and Hawaii to further expedite delivery due to its proximity to Los Angeles International Airport and several treatment facilities. The facility is being built to produce both Pluvicto (lutetium Lu 177 vipivotide tetraxetan) and Lutathera (lutetium Lu 177 dotatate), with potential to develop other RLTs in the future. A combined $200 million investment will optimize delivery of medicines to countries located in the Americas and worldwide.”
The Indianapolis facility will initially produce non-carrier added lutetium-177, which will be used to create doses of the Pluvicto and Lutathera products. Isotopes produced at the Indianapolis facility will be used in RLTs at Novartis RLT-manufacturing facilities across the US.
“Our strategy is to develop a pipeline that leverages our expertise and innovates across each RLT component including targets, vectors, linkers, and isotopes. We are investigating a broad portfolio of RLTs, exploring different isotopes, including actinium and lutetium, ligands, and combination therapies,” the spokesperson added.
Novartis also manufactures RLTs at sites in Ivrea, Italy and Zaragoza, Spain. According to the firm, these sites have the capacity to meet the needs of patients across the globe.
Novartis has recently made a string of investments in RLTs. In May, the firm acquired Mariana Oncology, a Watertown, Massachusetts-based biotech company dealing in RLTs worth $1 billion. Through this acquisition, the firm gained Mariana’s lead candidate for small cell lung cancer MC-339, an actinium-based RLT. Additionally, in December 2023, Novartis invested 600 million yuan ($84.6 million) to building a production site in Zhejiang province, China. The plant is expected to be operational by 2026.
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