Constructing the cGMP facility will increase availability of actinium-225, a nuclear material central to radiopharmaceutical programs at AstraZeneca, Bristol Myers Squibb, Eli Lilly and Novartis.
TerraPower Isotopes has committed $450 million to build a manufacturing facility in Philadelphia, setting the company up to increase production capacity for a key radioisotope by 20-fold.
The company, which was co-founded by Bill Gates, is working to increase availability of the alpha-emitting isotope actinium-225. Because actinium-225 emits more energy than lutetium-177, the beta-emitting isotope in Novartis’ Lutathera and Pluvicto, companies have identified the nuclear material as an enabler of next-generation radioligand therapies.
Rising demand has stretched supply, leading Bristol Myers Squibb’s RayzeBio to pause a Phase 3 trial over a shortage of actinium-225 in 2024. The situation has led companies including TerraPower to invest in capacity to make actinium-225.
Having initially served the market from Washington State, TerraPower announced Tuesday that it is establishing a presence on the East Coast by building a cGMP-compliant production facility in Philadelphia. Actinium-225 has a half-life of less than 10 days, making proximity to patients a key consideration when choosing the location of manufacturing plants.
The Commonwealth of Pennsylvania, which is investing $10 million in the project, said TerraPower will create 225 full-time jobs in Philadelphia over the next three years. The staff will work at a 250,000-square-foot facility that TerraPower is leasing on the site of the former Philadelphia Energy Solutions refinery. The company expects to start making actinium-225 at the facility in 2029.
TerraPower evaluated more than 350 locations in the U.S. and visited 49 sites in eight metropolitan areas before choosing Philadelphia’s Bellwether District as its East Coast base, according to its announcement.
The radioisotope manufacturer has disclosed actinium-225 supply deals with companies including Aktis Oncology, Clarity Pharmaceuticals and Point Biopharma, which Eli Lilly bought for $1.4 billion in 2023. TerraPower also struck a deal with PanTera, a European company that supplies actinium-225 to Bayer.
Historically, Oak Ridge National Laboratory met industry demand for actinium-225 through the decay of thorium-229 left over from nuclear weapons programs in the 1940s and 1950s. TerraPower, which was founded in 2018, and other companies invested in capacity as demand rose. BWXT Medical, Eckert & Ziegler, Ionetix, ITM, Niowave, NorthStar Medical Radioisotopes and Nusano are among the companies now supplying the isotope.
The suppliers are supporting an expanding pipeline. With companies including AstraZeneca, BMS, Lilly and Novartis entering the space, the number of new clinical trials involving actinium-225 has surged since the start of last year.