由 John R. Fischer
, Senior Reporter | February 04, 2021
German medical isotope producer Eckert & Ziegler is adding a new Current Good Manufacturing Practices (cGMP) production facility in the U.S. for contract manufacturing of radiopharmaceuticals.
The cGMP clean room suite is an expansion of its production side in Wilmington, Massachusetts, and will be a 21 CFR 211 compliant, radiopharmaceutical manufacturing facility for late stage investigational and commercial stage radiopharmaceuticals. The aim behind its establishment is to provide radiopharmaceutical development services to companies searching for U.S. and worldwide contract manufacturing.
“At the moment, a large number of radiopharmaceutical substances from international pharmaceutical companies are in advanced clinical trials, some of them for broad indications such as prostate cancer. With the new cGMP facility, we offer both regional and global pharmaceutical companies a one-stop service for a variety of radio-pharmaceutical services under cGMP conditions,” said Dr. Lutz Helmke, member of the executive board of Eckert & Ziegler AG and responsible for its medical segment, in a statement.
The company is completing a production facility at its Wilmington, Massachusetts site to produce yttrium-90 based radiopharmaceuticals to treat liver cancer, and plans to expand its European production capacity of Lutetium-177 labeled drugs to its U.S. site.
The new cGMP suite will enable it to offer complete early development services, including process development and scale-up, CMC manufacturing and packaging, product release and stability programs. Eckert & Ziegler will then be able to generate products on a clinical scale of phases I, II and III and for commercial use as a radiopharmaceutical contract manufacturer.
The facility will be operational by the end of 2021.