Eckert & Ziegler to Build cGMP Facility for Radiopharmaceutical Services in Berlin
2021-04-14 / Eckert & Ziegler is proud to announce that it is expanding its production site in Berlin, Germany, with a new production facility for the contract manufacturing of radiopharmaceuticals. This new cGMP clean room suite with a total area of around 270 m² will be a 21 CFR 211 compliant, radiopharmaceutical manufacturing facility dedicated to late stage investigational and commercial stage radiopharmaceuticals and be operational from the first quarter of 2022. Together with a new U.S. based cGMP facility, Eckert & Ziegler will be able to provide radiopharmaceutical development services to companies looking for Europe, US and worldwide contract manufacturing.
“We have decided to make this investment to meet the growing global demand for radiopharmaceutical services in both imaging and therapy products. 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," explains Dr. Lutz Helmke, member of the Executive Board of Eckert & Ziegler AG and responsible for the Medical segment. “The new cGMP facility enables positioning as a European production and development partner for specialized pharmaceutical companies and innovative scientists. We offer them a wide range of radiopharmaceutical services under GLP and cGMP conditions."
The new cGMP suite, will enable Eckert & Ziegler to offer complete early development services, including process development and scale-up, CMC manufacturing, product release, stability programs and packaging. The company will be able to manufacture products on a clinical scale for phases I, II and III as well as for commercial use as a radiopharmaceutical contract manufacturer.
Eckert & Ziegler has a global presence as one of the leading partners of the radiopharmaceutical industry and has production and sales sites in 13 countries in Europe, North and South America and Asia.
In Wilmington (MA), USA, a production plant is currently being completed to manufacture Yttrium-90 solution for liver cancer treatment. In the future, the company will expand its European production capacity for Lutetium-177 labeled drugs to its U.S. 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. Our production sites in Europe, Asia and North America ideally position Eckert & Ziegler to meet this demand," adds Dr. Lutz Helmke.
In Jintan (China), Eckert & Ziegler is investing up to EUR 50 million in the construction of a production facility for radiopharmaceuticals.