Radiopharmaceutical production and distribution company SOFIE has opened a new Theranostics Center of Excellence in Totowa, New Jersey.

The 20,000 square-foot facility will be used to manufacture and distribute multiple therapeutic radiopharmaceuticals to providers worldwide, as well as provide dosage for preclinical, clinical and commercial use. "With this investment SOFIE will continue to play a central role in the development and distribution of new and clinically relevant theranostic compounds. By having our own manufacturing center, it allows us to support the manufacturing needs of established Pharma entities, fulfill an important part of our strategic growth plan and offer professional opportunities to our community," Trevor Subero, SOFIE senior VP of business development, told HCB News.

The contract manufacturing site complies fully with both U.S. and EU regulations and is adjacent to an existing 10,000 square foot SOFIE diagnostic manufacturing site in Totowa. The company says that it will help in its partnership with academic and pharma entities. These partners include Lantheus Holdings, which has invested in the manufacturing of prostate cancer imaging agent, PyL (18F-DCFPYL); and Jubilant Radiopharma, which is helping SOFIE to continue to grow production capacity, advance its theranostic pipeline and support novel PET diagnostic manufacturing and distribution within the U.S.

Jubilant invested $25 million into the funding of the Theranostics Center of Excellence Manufacturing Facility back in 2020. The space includes five clean-rooms with isolators and hoods that can be used for aseptic manufacturing to support various processes, isotopes and production scales. It also can double the current footprint of the five Grade C (ISO 7) clean-rooms.

SOFIE serves more than 400,000 patients annually and supports R&D and contract manufacturing for both pharma partnerships and its own proprietary drug development efforts. The company also owns intellectual property called fibroblast activation protein inhibitor (FAPI) which has shown applicability across approximately 28 different cancers, and is effective in detecting non-oncologic diseases such as myocardial infarction and inflammatory fibrosis. "Each year advancements are made in the detection and therapeutic capabilities of compounds used to diagnose and treat an increasing number of diseases. These advancements are evident in the clinical trial and post FDA approval space."

The company previously expanded its reach when it acquired Cyclotope Radiopharmacy from Houston Cyclotron Partners back in 2019. The deal brought the number of radiopharmacies under SOFIE’s control to 17, and the company planned to expand into five additional markets over the next two years.

Originally Sofie Biosciences, the company rebranded in 2017 when it acquired Zevacor Pharma and its 16 radiopharmacies and contract manufacturing organization. The agreement supported clinical trials with the imaging and radiochemistry products of Sofie Biosciences, allowing both organizations to offer both clinical and life science services.

In addition to new theranostics, the two companies saw potential in FDG and expected it to continue to grow due to the use of FDG PET in treatment monitoring. They also expected that more studies on amyloid PET imaging in patient management for Alzheimer’s disease would help spur the growth of amyloid imaging.