The company has decided to build this new cGMP cleanroom suite that will be a 21 CFR 211 compliant radiopharmaceutical manufacturing facility dedicated to late-stage investigational and commercial-stage radiopharmaceuticals
Eckert & Ziegler has announced that it is expanding its production site in Wilmington, Massachusetts of a new production facility for the contract manufacturing of radiopharmaceuticals.
This new cGMP cleanroom suite will be a 21 CFR 211 compliant, radiopharmaceutical manufacturing facility dedicated to late-stage investigational and commercial-stage radiopharmaceuticals. Together with current facilities in Germany, the new US-based cGMP facility, will enable Eckert & Ziegler to provide radiopharmaceutical development services to companies looking for US and worldwide contract manufacturing.
"To meet the growing global demand for radiopharmaceutical services involving both imaging and therapy products, we have decided to make this investment. 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," explained Dr Lutz Helmke, member of the Executive Board of Eckert & Ziegler AG and responsible for the Medical segment. "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."
Currently, a production facility is being completed at the Wilmington, MA site to manufacture yttrium-90 based radiopharmaceuticals for the treatment of liver cancer. In the future, the company will expand its European production capacity for Lutetium-177 labelled drugs to its US site.
Lutetium-177 is a coveted active ingredient in many new cancer therapy drugs. "Due to the large number of studies in which lutetium-177 is being clinically tested worldwide, we expect an increasing demand for this isotope and related services in the coming years. With our production sites in Europe, Asia and North America, we believe we are ideally positioned to meet this demand," added Helmke.
The new cGMP suite will enable Eckert & Ziegler to offer complete early development services, including process development and scale-up, CMC manufacturing and packaging, product release and stability programs. The company will thus be able to manufacture products on a clinical scale of phases I, II and III and for commercial use as a radiopharmaceutical contract manufacturer.