Isotopia USA has chosen E Solutions to design and build its state-of-the-art GMP manufacturing centre.
Isotopia Molecular Imaging is a dominant Lutetium (177Lu) Non-Carrier-Added supplier.
The companies have signed commitments for this GMP centre, as 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.
E Solutions and Comfort Systems have a reliable history of executing multiple FDA-regulated installations in the radiopharmaceutical industry on time and within budget
E Solutions, a division of Comfort Systems, is a supplier of state-of-the-art cleanrooms and GMP laboratories, as well as shielded isolators and hotcells tailored for radioisotope and radiopharmaceutical manufacturing.
The facility will encompass 28,000 sqft of cleanrooms, and 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.
CEO of Isotopia USA, Todd Hockemeyer said: "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, added: "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 endeavour."