Fully Automated Methods for [18F]FDG and [18F]-NaF Productions Using Explora FDG4: Validation and Reliability of Multi-subsequent Preparations for Clinical Applications

Abstract

Background: The worldwide usage of [18F]-sodium fluoride in clinical applications increase the interest of the facility of its production. The development of a new automated method for multi-preparations of [18F]-NaF and [18F]FDG on an Explora FDG4 module is described. Explora FDG4 is one of the most widely used synthesizers for FDG production in daily routine use and specifically designed to run up to four different productions with single module. Therefore, slight modifications were carried out in order to increase the potential of the synthesizer to perform more radiopharmaceuticals. Methods: A fully automated method for multi-preparations of [18F]-NaF and [18F]FDG using Ex-plora FDG4 was developed. Slight modifications to the Explora’s hardware and software configu-ration were applied. A new elution vial for NaF preparation was installed and connected to the free position to MVP1. Quality control was carried out using the standard analytical methods applied for GMP production. Results: This modification successfully provides preparation of [18F]-NaF without affecting the daily FDG production using one set preparation. [18F]-NaF was obtained in a high radiochemical yield (>90%, n=100) in 10 min total preparation time. The quality control results for both obtained products, FDG (RCP >95%) and NaF (RCP >98%), showed that the radiopharmaceuticals were in compliance with USP and Ph.Eur. specifications and compatible with clinical applications. Conclusion: A rapid and simple method for multi preparations of [18F]-NaF and [18F]FDG using a single Explora module was designed. Yet, the chemistry module has the potential to generate more radiopharmaceuticals to decrease the cost of preparation of [18F]-NaF compared to the cassette-based synthesizers, reducing radiation exposure resulting from manual preparations and increasing the reproducibility of [18F]-NaF preparation.