PRODUCTION PLANT
Porto Alegre (Rio Grande do Sul)
Porto Alegre's R2 IBF plant has been operating in the Brazilian market since 2010, the year in which it obtained marketing authorization from the Brazilian Health Regulatory Agency (ANVISA), the Brazilian National Commission for Nuclear Energy (CNEN) and other agents. Since then, it has been benefiting patients in several Brazilian states by providing the 18F-FDG, helping to obtain increasingly accurate PET-CT diagnoses. In 2011, it became the first production unit in Brazil to obtain certification in Good Radiopharmaceutical Manufacturing Practices (GRMP) by ANVISA. In 2017, once again, it demonstrated pioneering in the area, being the second company in Brazil to obtain the registration for the fludesoxyglucose (18 F). Installed in Porto Alegre, state of Rio Grande do Sul, R2 IBF has a lean multidisciplinary team of pharmacists, engineers, physicists, technicians and administrators who guarantee the supply of Fluesocil® (fludesoxyglucose (18 F)) to customers located in the South and Southeast regions of the country.
The Fluesocil® (fludesoxyglucose (18 F)) manufactured by R2 IBF is a radiopharmaceutical used in Positron Emission Tomography (PET-CT), in nuclear medicine, with applications in cardiology, neurology, and especially in oncology. The use of FDG (18 F) in PET-CT studies is especially important because it allows a metabolic evaluation related to the body's glucose consumption, which gives it a prominent role in the diagnosis and staging of the tumor, as well as in the early evaluation of efficacy of the therapeutic protocols adopted in patients with certain types of cancer. Studies indicate that after 18F-FDG PET-CT procedures, the therapeutic approach is changed in approximately 30% of cases. This represents a very important gain in healing expectancy, quality of life, time and cost of treatment.
Our mission
We work to providing exceptional outcomes to our customers and their patients.
Focus
To develop, manufacture and supply high quality radiopharmaceutical products to our customers.
Always support the growth of nuclear medicine in Brazil, offering new products with excellence.
Ethics & Responsibility
We respect our partners and our customers.
We understand its importance in the present and future of our company.
We have responsibility with our collaborators, our community, our country; therefore, we work with a focus on ethics and commitment to the development of the people and the environment in which we are inserted.
PRODUCT
Porto Alegre (Rio Grande do Sul)
FLUESOCIL®
fludesoxyglucose (18 F)
Presentation: Shielded packaging containing 01 multidose vial
Pharmaceutical Form: Sterile Solution
Route of administration: Intravenous
Composition: Each radiopharmaceutical vial contains:
Fludesoxyglucose (18 F) …………… 10mCi
Excipients: 0.9% sodium chloride and water for injection.
Physical half-life: 109.7 minutes
Indications: Positron Emission Tomography (PET and PET-CT) imaging diagnosis for oncological, brain and cardiac studies.
Describe your image
Describe your image
TECHNOLOGY
Porto Alegre (Rio Grande do Sul)
The R2 IBF of Porto Alegre has a cyclotron accelerator manufactured by Ion Beam Applications (IBA), a Belgian firm . It is an 18 MeV energy cyclotron and is intended for radioisotopes production for nuclear medicine, mainly in Positron Emission Tomography. Among them, the most interesting is 18F, obtained from irradiation of water enriched in 18O with protons. The 18F produced in cyclotron is transferred via an underground line to a laboratory and is used for the synthesis of the active ingredient fludesoxyglucose, FDG (18F), a glucose analog (deoxyglucose) which is linked to the 18F radioisotope.
The plant has three modules for the synthesis of FDG (18F), which use disposable cassettes: one of them, manufactured by GE (General Electric), FASTlab 2 model, allows the accomplishment of two consecutive syntheses, with high yield and reliability; and two other modules made by IBA, Synthera model. This infrastructure provides the production of high activities with flexibility and reliability. Both cyclotron and synthesis module operations are performed automatically using software installed on dedicated computers.
QUALITY AND CONTINUOUS IMPROVEMENT
Porto Alegre (Rio Grande do Sul)
COMMITMENT TO QUALITY. FOCUS ON CONTINUOUS IMPROVEMENT.
Established in August 2019, R2 IBF focuses on developing, producing and supplying quality radiopharmaceuticals to our customers and supporting the growth of nuclear medicine in Brazil. For this we have three production plants, strategically located in the cities of Porto Alegre (Rio Grande do Sul), Curitiba (Parana) and Sao Jose do Rio Preto (Sao Paulo) and, soon, we will start the routine production of the most modern radiopharmaceutical plant in Brazil, in Duque de Caxias (Rio de Janeiro). Together, the plants result in an excellent production capacity, about 50Ci of FDG per fludesoxyglucose (18 F) radiopharmaceutical production batch. This structure gives our customers and partners greater peace of mind and security in the daily receiving of the drug by establishing safer and more efficient logistics, as well as the back-up supply system required during preventive and corrective maintenance periods.
Still, in a pioneering way, the R2 IBF became the first private company in the Brazilian industry to form a group of research, development and innovation for new radiopharmaceuticals, thereby hope to soon increase its portfolio with new radiopharmaceuticals, including:
18F-PSMA-1007: for prostate cancer diagnosis - tumor localization in recurrent prostate cancer; initial staging in patients with high-risk prostate cancer before surgical planning or radiotherapy; PSMA PET-guided biopsy after a negative biopsy; monitoring of systemic treatment in metastatic prostate cancer.
18F-Flutemetamol: used for PET imaging to assess the density of β-amyloid plaques in the cerebral parenchyma of patients with cognitive decline, whether suspected of dementia due to Alzheimer's disease or other suspected dementias.
We understand that our customers and partners are very important for our development, so we work with focus on ethics and commitment to the development of people and the environment in which we operate.
Rua Provenzano 171 Porto Alegre - RS
CEP 90200-200 Tel: +55 51 3016 7200
