In the midst of being approved for commercial manufacturing of Pluvict, the 70,000 square-foot site was built specifically to accommodate RLT production.
Novartis has received approval from the FDA for commercial manufacturing of Pluvict (lutetium vipivotide tetraxetan) at its new large-scale, state-of-the-art radioligand therapy (RLT) manufacturing facility in Indianapolis. The 70,000-square foot site, the company’s second US location, was designed with RLT manufacturing in mind, and, according to the manufacturer, is the largest and most advanced Novartis facility of its kind. Looking ahead, the new site is expected to help provide substantial RLT supply increases for the foreseeable future.
“The intricate process of providing RLTs to patients within hours of production requires precision manufacturing expertise to bring these medicines to individuals who critically need them,” says Steffen Lang, Novartis’ president of operations. “Adding a second US RLT facility, our largest and most advanced yet, into our manufacturing network underscores our commitment to ensure a consistent and reliable experience for patients and their healthcare teams for years to come.”
The Indianapolis facility is purpose-built from the ground up to manufacture RLTs both now and into the future, and includes space for continued line expansion including plans for fully automated lines, a first for the radiopharmaceutical industry. The new site will supply the growing demand for patients in the United States and eventually in Canada, upon approval, alongside the company’s Millburn, NJ location. The site in Ivrea, Italy will continue to supply patients in and outside the United States while the facility in Zaragoza, Spain will exclusively provide RLTs for patients outside the United States.
The manufacturer also recently announced that supply of Pluvicto is unrestricted. Having doubled weekly production, Novartis currently has enough supply to treat patients within two weeks of diagnosis.
Novartis expands production of Pluvicto with addition of its largest and most advanced radioligand therapy manufacturing facility in Indianapolis. Novartis. News release. January 5, 2024. Accessed January 5, 2024. https://www.novartis.com/news/media-releases/novartis-expands-production-pluvictotm-addition-its-largest-and-most-advanced-radioligand-therapy-manufacturing-facility-indianapolis?utm_source=pitch&utm_medium=email&utm_campaign=IndyFDA