Over the next 12 months, Isotopia USA will build a GMP manufacturing plant that will allow it to produce a high volume of non-carrier-added Lutetium-177 (177Lu), Terbium-161 (161Tb), and other isotopes as therapeutic cancer treatments for distribution in the U.S.

Based in Indiana, the company is a dominant supplier of 177Lu n.c.a, which has become a widely used radionuclide in targeted therapy and theranostics for treating neuroendocrine tumors and metastatic castration-resistant prostate cancer (mCRPC). 161Tb is also used as a targeted radionuclide treatment for prostate cancer.

Isotopia USA expects to provide GMP-grade products to customers in Q4 2024. For the project, it has appointed E Solutions, a division of Comfort Systems and a supplier of state-of-the-art clean rooms and GMP laboratories, to oversee design and construction. The facility will include 28,000 square-feet of clean rooms and analytical and microbiological laboratories that are necessary for the amounts of 177Lu and 161Tb that the company is looking to distribute.
"E Solutions and Comfort Systems have a reliable history of executing multiple FDA-regulated installations in the radiopharmaceutical industry on time and within budget. Just as importantly, their expertise in clean room technology, clean air ventilation, and building management systems make them an important partner in ensuring our success in completing this project,” said Isotopia USA CEO Todd Hockemeyer in a statement.

Isotopia USA is part of Isotopia Molecular Imaging, which is made up of nuclear pharmacists, radiochemists, nuclear engineers, and physicists and has a nuclear pharmacy, cyclotron facility, 177Lu production sites, and a sterile manufacturing plant. It has entered several supplier partnerships in the last few years to scale its ability to distribute 177Lu n.c.a.

In 2022, the Centre for Probe Development and Commercialization (CPDC), in Canada, used its technology to produce the radioisotope at its GMP facility and then shipped its first doses of commercial 177Lu n.c.a. in North America.

It also has contracts with Seibersdorf Labor, a GMP contract manufacturer of radiopharmaceuticals, and Clovis Oncology, which used its supply of 177Lu to clinically produce FAP-2286 to treat advanced solid tumors as part of trials.

Isotopia USA was not available for comment.

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