Study for implantation of the radiopharmaceutical FES-18F process production in an automated system: process validation and analytical methods approach

• Grant number: 18/13096-0
• Support type: Scholarships in Brazil - Master
• Effective date (Start): September 01, 2018
• Effective date (End): July 31, 2020
• Field of knowledge: Engineering - Nuclear Engineering - Applications of Radioisotopes
• Principal Investigator: Elaine Bortoleti de Araújo
• Grantee: Luiza Mascarenhas Balieiro
• Home Institution: Instituto de Pesquisas Energéticas e Nucleares (IPEN). Secretaria de Desenvolvimento Econômico (São Paulo - Estado). São Paulo , SP, Brazil
• Associated research grant: 17/50332-0 - Scientific, technological and infrastructure qualification in radiopharmaceuticals, radiation and entrepreneurship for health purposes, AP.PDIP

Abstract

Breast Cancer is one of the main neoplasia that affect women and the second largest cause of mortality in the world, the advance for early diagnosis can be with the use of Radiopharmaceutical FES-18F, because it has affinity for the Estrogen Receptor present in 75 % of breast cancer cases being possible for non-invasive diagnosis and follow-up of the patient. For the FES-18F synthesis, a set of commercial reagents is used, adapted to an automated synthesis module that operates through software; the validation of the production process and analysis of the quality controls of the product, are an essential part of GMP and should follow the standards of international agencies and national agencies such as the National Sanitary Surveillance Agency (ANVISA). In order for this new Innovator radiopharmaceutical (never before marketed in the country) to be registered, results of pre-clinical studies must be presented and are contemplated in this Project. The elaboration and commercialization of this new radiopharmaceutical is of interest for Brazilian nuclear medicine.