Scale-up production of [²¹¹At]PSMA-5 using automated synthesizer for Investigator-Initiated clinical trial.

ABSTRACT:

Background

[²¹¹At]PSMA-5 is a novel α-emitting therapeutic agent designed to target prostate-specific membrane antigen (PSMA), which is overexpressed in metastatic castration-resistant prostate cancer (mCRPC). Unlike β-emitting radioligands, [²¹¹At]PSMA-5 delivers highly localized cytotoxicity while minimizing damage to surrounding normal tissues. To enable clinical application, the objective of this study is to scale up the lab-scale synthesis to an automated manufacturing process that ensures high reproducibility and sufficient radioactivity for human administration.

Results

We developed and optimized a scalable automated synthesis method for [²¹¹At]PSMA-5 using the COSMiC-Mini VTRSC2 automated synthesizer. Optimization involved evaluating

SUBMITTER: Naka S 

PROVIDER: S-EPMC12852524 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature