Totowa, NJ, April 27, 2022– SOFIE Inc. (SOFIE), a Theranostics company headquartered in Dulles, VA, commissions its new radiopharmaceutical contract manufacturing facility in Totowa, NJ. This technologically advanced facility will efficiently manufacture and distribute multiple therapeutic radiopharmaceuticals to treat patients worldwide. It will be fully US and EU regulatory compliant and will provide doses for pre-clinical, clinical, and commercial use. This achievement is an integral part of SOFIE's strategic goal of collaborating with academic and pharma entities to develop and supply clinically relevant radiopharmaceuticals.
Located adjacent to an existing 10,000 square foot SOFIE diagnostic manufacturing site in Totowa, the footprint will be approximately 20,000 square feet. The GMP space will include five cleanrooms containing isolators and hoods suitable for aseptic manufacturing to support a variety of processes, isotopes, and production scales. This space is designed to be further expandable, doubling the current footprint of the 5 Grade C (ISO 7) cleanrooms.
The SOFIE team at The Theranostics Center of Excellence, brings over 60 years of collective expertise in radiopharmaceutical development. Barry Dembowski, Director RCM Commercial Mfg., Facility Manager, stated; “This new Theranostics Center of excellence significantly expands our radiopharmaceutical development, manufacturing, and distribution capacity, while providing critical patient-care services in coordination with our contract partners. Along with this expansion, we continue to grow our team of talented professionals while engaging in this rewarding field of work.
SOFIE’s Chief Revenue Officer, Philipp Czernin added: “The Theranostics Center of Excellence is a crucial piece to our growth strategy, specifically around the manufacturing of therapeutic radiopharmaceuticals.”
SOFIE’s vision is to improve patient outcomes by developing and delivering molecular diagnostics and therapeutics (Theranostics). With its robust radiopharmaceutical production and distribution network, mature contract manufacturing services, and now, high value Theranostic intellectual property, SOFIE is poised to deliver on the promise of nuclear medicine. For more information, please visit https://sofie.com or contact firstname.lastname@example.org