Production and quality control according to current Good Manufacturing Practice of the radiopharmaceutical 18F-Fluoromethylcholine

Prostate cancer is the most common malignancy in men and is the third leading cause of cancer death in men. Diagnostic techniques for the identification of tumor site and biochemical recurrence are diverse. Today, imaging techniques play a fundamental role in the diagnosis and staging of cancer. Using PET analysis and radiotracers, tumor mass can be identified and its staging determined. Choline is a substrate for the synthesis of phosphatidylcholine and an important phospholipid in cell membranes. Cell membrane biosynthesis is rapid in tumor tissues, and positive regulation of malignancy-induced choline kinase activity results in increased choline uptake by tumor cells. PET-CT imaging with radiolabeled choline allows the localization of the disease in PCa patients with biochemical recurrence after primary treatment. The main advantage of this method is its ability to assess disease recurrence at multiple anatomical sites with greater accuracy than conventional CT and MRI imaging. The increasing use of 18F-FCH has led to the commercial availability of this tracer. To meet the demand for 18F-FCH, a high-throughput manufacturing process is required. Using the new synthesis process compared to the one currently in use, the amount of 18F-FCH available for PET analysis is significantly increased. To ensure the quality of 18F-FCH, GMP standards must be applied starting from the design and implementation of manufacturing and quality control activities. Chemical and microbiological quality control equipment and methods must be validated to ensure the quality and safety of the product. Finally, the entire manufacturing process must be validated to meet all GMP standards.