Eckert & Ziegler Receives GMP Certificate for Actinium-225

Braunschweig, Germany, 28 October 2026. Eckert & Ziegler Therapeutics GmbH, wholly owned subsidiary of Eckert & Ziegler SE (ISIN DE0005659700, TecDAX), has received the manufacturing authorization for Actinium-225 (Ac-225). The certification by the competent German authority confirms that production meets the stringent requirements of Good Manufacturing Practice (GMP) and facilitates the use of the radioisotope for the investigational treatment of patients.

Actinium-225 is widely regarded as one of the most promising alpha emitters for use in targeted radiopharmaceutical applications. This is reflected in both the increasing number of clinical trials investigating this radionuclide and the advancement of clinical programs into later-stage development.

“This regulatory milestone is the decisive step that turns our production capability into a supply commitment the field can build their clinical and commercial programs on,” said Dr. Gunnar Mann, Member of the Executive Board and responsible for Operations at Eckert & Ziegler’s Medical Segment. “We have quickly moved from first production runs in our upscaled process to GMP grade routine manufacturing. This is what improving supply security looks like in practice.”

The overall production route uses cyclotron-based irradiation of Radium-226 (Ra-226) at the Řež facilities of the Czech Academy of Sciences’ Nuclear Physics Institute (Ústav jaderné fyziky, “UJF”). Afterwards the irradiated material is processed at Eckert & Ziegler’s Braunschweig site to obtain GMP grade Ac-225. Production activities at both sites are supported by custom-engineered hot cell systems from Isotope Technologies Dresden GmbH, Eckert & Ziegler’s hot cell division.

The proprietary process set up by Eckert & Ziegler ensures that the cyclotron-based production of Ac-225 results in an isotopic profile with long-lived impurities such as Actinium-227 and Thorium-229 kept to a minimum, thereby meeting the expectations of nuclear medicine physicians and radiopharmacists alike.

Secured access to Radium-226
Accessing Ra-226 as the precursor material is one of the principal bottlenecks in global Ac-225 production. To alleviate the pressure on its supply chain, Eckert & Ziegler has integrated the repurposing of Ra-226 legacy sources into its sourcing strategy. Additionally, the production method recovers unconverted Ra-226 after irradiation and reintroduces it to the process, allowing the material to be used across multiple cycles. This helps reduce dependency on constrained global Ra-226 inventories while limiting radioactive waste, contributing to more predictable output volumes and costs for both radioisotope supply and CDMO programs.

Capacity expansion in Asia and North America
The newly opened production facility of Eckert & Ziegler’s joint venture Qi Kang Medical Technology (Changzhou) Co., Ltd. in Jintan, China is intended to become the first site in the country dedicated to the production of Ac-225 on a commercial scale. This second phase is planned to be realized after initial operations start in early 2027.
In addition, further capacity expansion can be considered at Eckert & Ziegler’s established radiopharmaceutical manufacturing site near Boston, MA, USA, as well as in Germany, to support the future commercial supply of Ac-225-based medicinal products.

About Eckert & Ziegler
Eckert & Ziegler SE, with more than 1,100 employees, is THE leading independent radioisotope supplier and a specialist in isotope-related components for nuclear medicine and radiation therapy. The company offers a broad range of services and products for the radiopharmaceutical industry, from early development work to contract manufacturing and distribution. Eckert & Ziegler shares (ISIN DE0005659700) are listed in the TecDAX index of Deutsche Börse.
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