Banca de QUALIFICAÇÃO: GABRIELA LEMOS RIBEIRO DE SOUZA

Uma banca de QUALIFICAÇÃO de MESTRADO foi cadastrada pelo programa.
STUDENT : GABRIELA LEMOS RIBEIRO DE SOUZA
DATE: 09/11/2023
TIME: 09:00
LOCAL: Campus CVI
TITLE:

DEVELOPMENT, OPTIMIZATION AND VALIDATION OF ANALYTICAL METHODOLOGY APPLIED TO HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY FOR THE CHARACTERIZATION OF THE RADIODRUG PSMA-1007 (18F).

KEY WORDS:

radiopharmaceutical, PSMA, Quality Control, HPLC

PAGES: 52
BIG AREA: Ciências Exatas e da Terra
AREA: Química
SUBÁREA: Química Analítica
SPECIALTY: Separação
SUMMARY:

In Brazil, prostate cancer is the second most common type of malignant tumor in males, and if detected early, the chance of cure increases significantly. In nuclear medicine, radiopharmaceuticals have been widely used for diagnostic and/or therapeutic purposes of the disease, such as in Positron Emission Tomography and Computed Tomography (PET/CT) examinations. When administered to the patient, the radiopharmaceutical is directed to an organ of interest for the physiological or pathophysiological function of the disease. Prostate Specific Membrane Antigen PSMA-1007(¹⁸F) is a novel radiopharmaceutical that has a positron-emitting radionuclide and is used for diagnostic purposes. In cancer prostate cells, PSMA is overexpressed, so PSMA molecules labeled with ¹⁸F will bind with high affinity to them. The accumulation of PSMA-1007(¹⁸F) in these cells allows PET images to be obtained revealing the presence of the tumor, as well as its extent and aggressiveness. The synthesis of this radiopharmaceutical is carried out via nucleophilic substitution, where the radiolabeled fluoride (¹⁸F^-) attacks the precursor of the reaction C₅₄H₆₄F₃N₉O₁₈, and for its use to be safe, ANVISA recommends quality control tests that meet the Good Manufacturing Practices established by the regulatory body.

In order to optimize quality control, an analytical method was developed and implemented in High Performance Liquid Chromatography (HPLC) to determine the purity and radiochemical identification of the markings. The method developed in the present study in relation to the methodology previously developed by the group, which was based on the European Pharmacopoeia, presents some advantages such as the replacement of the organic solvent by a cheaper, easier to purchase and less toxic solvent, the change of the aqueous solvent for one that does not cause column clogging and the reduction of the running time from 21 minutes to 10 minutes. As a consequence, there was a lower solvent consumption, less generation of chemical waste, cost of the experiment and health risks, resulting in a more sustainable process.

COMMITTEE MEMBERS:
Presidente - PATTERSON PATRICIO DE SOUZA
Externo ao Programa - CLEVERSON FERNANDO GARCIA