Automated synthesis of [¹⁸F]Ga-rhPSMA-7/ -7.3: results, quality control and experience from more than 200 routine productions.

ABSTRACT:

Introduction

The radiohybrid (rh) prostate-specific membrane antigen (PSMA)-targeted ligand [¹⁸F]Ga-rhPSMA-7 has previously been clinically assessed and demonstrated promising results for PET-imaging of prostate cancer. The ligand is present as a mixture of four stereoisomers ([¹⁸F]Ga-rhPSMA-7.1, - 7.2, - 7.3 and - 7.4) and after a preclinical isomer selection process, [¹⁸F]Ga-rhPSMA-7.3 has entered formal clinical trials. Here we report on the establishment of a fully automated production process for large-scale production of [¹⁸F]Ga-rhPSMA-7/ -7.3 under GMP conditions (EudraLex).

Methods

[¹⁸F]Fluoride in highly enriched [¹⁸O]H₂O was retained on a strong anion exchange cartridge, rinsed with anhydr

SUBMITTER: Wurzer A 

PROVIDER: S-EPMC7826325 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature