Isotopia USA and E Solutions have signed commitments to design-build its state-of-the-art GMP manufacturing center. Isotopia plans to establish its US isotope manufacturing operations over the next 12 months and anticipates providing GMP-grade products to its key customers in Q4 2024. The facility will encompass 28,000 ft2 of cleanrooms, analytical and microbiological laboratories needed for high-volume production of Lutetium-177 n.c.a. (177Lu) and Terbium-161(161Tb) isotopes. These drug substances act as the critical ingredients of targeted nuclear medicine for improving cancer patients' overall survival and quality of life.
Isotopia USA CEO, Todd Hockemeyer stated:
"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 cleanroom technology, clean air ventilation and building management systems make them an important partner in ensuring our success completing this project."
Greg Bielefeld, President of E Solutions, stated:
"Our team is very excited to extend our relationship with the world-class professionals at Isotopia. They are an industry leader in the production of cancer treatments, and we cannot be more proud to support them in their endeavor."
About Isotopia.
Isotopia Molecular Imaging Ltd. is a dominant Lutetium (177Lu) Non-Carrier-Added supplier. Our multidisciplinary development team consists of nuclear pharmacists, radiochemists, nuclear engineers, and physicists. Together with our nuclear pharmacy, cyclotron facility, 177Lu production sites and sterile manufacturing plant, Isotopia is a well-established platform for managing the entire process from manufacturing through to delivery. Isotopia creates collaborations between the scientific and medical community to further develop and experiment with new markers for molecular therapy and imaging applications.
About E Solutions and Comfort Systems USA.
E Solutions, a division of Comfort Systems, is a leading supplier of state-of-the-art cleanrooms and GMP laboratories, as well as shielded isolators and hotcells tailored for radioisotope and radiopharmaceutical manufacturing. Comfort Systems USA is a leading building and service provider for mechanical, electrical and plumbing systems. In June, 1997, the company went public with 12 operating companies. Today, Comfort Systems is composed of more than 45 operating companies in over 170 locations across the United States delivering expert resources necessary to perform a range of services including process piping, modular construction, and building automation controls.
