Scale-up production of [211At]PSMA-5 using automated synthesizer for Investigator-Initiated clinical trial
This study successfully established an automated, scalable production process for [<sup>211</sup>At]PSMA-5 that meets clinical-grade quality requirements, enabling stable and reproducible manufacturing for investigator-initiated clinical trials in mCRPC. Equivalent radiochemical yields and consistent quality were obtained using irradiated Bi targets from two cyclotron facilities (RCNP and RIKEN), demonstrating site-independent robustness. This flexible system ensures a reliable supply and resilience to unexpected cyclotron downtime, representing a significant step toward clinical application of <sup>211</sup>At-based PSMA-targeted alpha therapy.
Authors
- Yoshifumi Shirakami (ORCID: https://orcid.org/0000-0003-2352-9057)
- Noriyuki Tomiyama (ORCID: https://orcid.org/0000-0001-9918-7327)
- Kenta Kurimoto
- Kayako Isohashi (ORCID: https://orcid.org/0000-0002-2081-3020)
- Jens Cardinale (ORCID: https://orcid.org/0000-0001-6558-966X)
- Kazuhiro Ooe (ORCID: https://orcid.org/0000-0002-8560-027X)
- Frederik Lars Giesel (ORCID: https://orcid.org/0000-0002-9669-5593)
- Y. Kon
- Sadahiro Naka
- Hiromitsu Haba
- Tadashi Watabe
- Toshihiro Sakai
- Atsushi Toyoshima
- Masashi Murakami
Institutions
- Düsseldorf University Hospital (DE)
- Osaka University Hospital (JP)
- RIKEN Nishina Center (JP)
- Heinrich Heine University Düsseldorf (DE)
- The University of Osaka (JP)
Publication Details
- Journal
- EJNMMI Radiopharmacy and Chemistry
- Published
- 2025-12-27
- DOI
- https://doi.org/10.1186/s41181-025-00416-w
- Primary Topic
- Radiopharmaceutical Chemistry and Applications
- Type
- article
- Field-Weighted Citation Impact
- 0.00