Eckert & Ziegler Gains GMP Certification for Key Cancer Therapy Isotope

Eckert & Ziegler SE has received Good Manufacturing Practice (GMP) certification for the production of Actinium-225 (Ac-225), a key radioisotope utilized in targeted cancer therapies, according to a company announcement on October 28, 2026. This certification validates the company’s production processes against stringent quality standards and facilitates the use of Ac-225 in clinical trials and potential patient treatments.

Actinium-225 is increasingly recognized as a promising alpha emitter for radiopharmaceutical applications, evidenced by the growing number of clinical studies and the advancement of related clinical programs. The GMP certification marks a critical turning point, transforming Eckert & Ziegler’s production capability into a reliable supply commitment for the industry. The company has swiftly transitioned from initial production runs to routine GMP-grade manufacturing, demonstrating improvements in supply chain security.

The production process involves irradiating Radium-226 (Ra-226) at the Czech Academy of Sciences’ Nuclear Physics Institute, followed by processing at Eckert & Ziegler’s Braunschweig facility. This process leverages custom-engineered hot cell systems from the company’s own Isotope Technologies Dresden GmbH division. Eckert & Ziegler’s proprietary method ensures a high-purity Ac-225 product with minimized impurities, meeting the stringent requirements of nuclear medicine professionals.

To secure access to the necessary Ra-226, a key limiting factor in Ac-225 production, Eckert & Ziegler is actively repurposing legacy sources and recycling unconverted Ra-226. This strategy aims to reduce reliance on limited global inventories and minimize radioactive waste. Further, the company is establishing a new production facility in Jintan, China, through its joint venture Qi Kang Medical Technology, projected to begin operations in early 2027. Expansion of existing facilities in the US and Germany is also under consideration to meet future demand for Ac-225-based therapeutics.

Eckert & Ziegler’s successful attainment of GMP certification and its proactive capacity expansion plans position the company to capitalize on the growing demand for Actinium-225, potentially solidifying its role as a leading supplier in the radiopharmaceutical market. The company’s integrated approach to sourcing and production, combined with its strategic partnerships, addresses critical supply chain challenges in this emerging field.