Telix and Ekalia Sign Collaboration to Scale Astatine-211 Production

Telix Pharmaceuticals and Ekalia have formalized a collaboration to establish dedicated astatine-211 (²¹¹At) production capacity inside the U.S., a move that places alpha-emitting isotope manufacturing directly within an existing GMP radiopharmacy network rather than at a centralized, remote facility. For plant heads and QA directors working in radiopharmaceutical manufacturing, the model signals a structural shift toward point-of-need production for short-lived isotopes, one that will carry distinct implications for facility qualification, radiation safety programs, and isotope handling procedures under 21 CFR Part 211.

The first IBA alpha-beam cyclotron will be installed at Telix's RLS Trevose site near Philadelphia, PA. Ekalia, a joint venture between IBA (Ion Beam Applications S.A.) and Framatome, contributes cyclotron technology and nuclear production expertise developed through an existing European industrial-scale ²¹¹At program. The collaboration extends that framework into the U.S., with the RLS Trevose installation intended to establish a reproducible production model before potential rollout across additional RLS network sites as demand develops.

²¹¹At is an alpha-emitting radioisotope under investigation for targeted alpha therapy (TAT). Its clinical utility has been constrained by limited production infrastructure, a bottleneck documented in peer-reviewed literature, rather than by therapeutic rationale. The collaboration is designed to address that supply gap by positioning production assets in proximity to clinical centers, reducing the logistical burden imposed by the isotope's short physical half-life.

For Telix, the arrangement is expected to support TLX102-Tx (²¹¹At astato-L-phenylalanine), a TAT candidate in evaluation for glioblastoma and leptomeningeal disease, alongside future ²¹¹At pipeline programs. The framework also provides production capacity for third-party academic and industry programs, positioning the RLS network as shared infrastructure within the broader U.S. ²¹¹At development ecosystem.

QA and regulatory leads should note that alpha-emitter production at distributed radiopharmacy sites introduces facility-level considerations beyond standard PET or SPECT isotope handling, including shielding validation, waste stream classification, and process validation protocols specific to cyclotron-produced alpha emitters. How Telix and Ekalia define and document the reproducible production model at RLS Trevose will likely set a reference point for subsequent site qualifications across the network.

The reproducibility and scalability of the RLS Trevose production model, and the timeline for any subsequent site installations, will be the measurable checkpoints against which this collaboration's operational claims are tested.

Source: Telix Pharmaceuticals Limited via telixpharma.com, October 19, 2026.