Produced at BraIns, compound named Glicocer has been accredited by the national agency
Anvisa, the National Health Surveillance Agency has just accredited radiopharmaceutical Fludesoxyglucose (18F), produced at the Center for Production of Radiopharmaceuticals (CPR) of the Brain Institute of Rio Grande do Sul – PUCRS (BraIns). The product will be renamed Glicocer and will be used in positron emission tomography (PET) exams, in the areas of oncology, cardiology and neurology. Glicocer is a medicinal radiocompound, that is, a radioactive drug. BraIns is equipped with a particle accelerator – Cyclotron – which produces the necessary radiation for the production of the drug.
To be used exclusively in diagnostic imaging, Glicocer has been in use at the institute since 2014, as its permission was granted by Anvisa, as per the Collegiate Board Resolution – RDC No. 66 dated Dec 09, 2011 and Collegiate Board Resolution – RDC No. 70 dated Dec 23, 2014. Glicocer will come in 11 different forms, according to the dosage, from 1 to 11 mCi. Louise Hartmann, coordinator of the CPR, claims that the certification of the drug by Anvisa is a statement of quality, effectiveness and security for the drug produced at BraIns. “On top of that, it is important to stress that the center has been granted a Certificate of Good Fabrication Practices (CBPF), which was also issued by the agency, and which corroborates with the quality of our processes and products”, says she.
Glicocer is the sixth medication to have Fludesoxyglucose (18 F) as an active principle, to be registered in Brazil. In addition to a Center for Production of Radiopharmaceuticals accredited by Anvisa, the institute is equipped with a PET Diagnostic Imaging Center to be used for nuclear medicine exams. “Radiopharmaceuticals produced at CPR can be used at the institute’s Imaging Center, which makes it possible for our team of researchers to investigate conditions such as Alzheimer’s and Epilepsy further. Besides, we are also working on the development of new medicinal radiocompounds, to treat diseases such as prostate cancer”, claims Louise.