PRODUCTION PLANT
Sao Jose do Rio Preto (Sao Paulo)
R2 IBF, Sao Jose do Rio Preto plant, has a team of qualified employees who work in accordance with the principles of Good Manufacturing Practices (GMP) established by the Brazilian Health Regulatory Agency (ANVISA). The laboratory has modern dedicated equipment for Quality Control testing, which guarantees a high quality and reliable product.
The company produces the radiopharmaceutical Fluodesoxyglucose - 18 F registered under the name Flutep®.
The Flutep® (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
Sao Jose do Rio Preto (Sao Paulo)
FLUTEP®
fludesoxyglucose (18 F)
The company produces the radiopharmaceutical Fluodesoxyglucose-18F registered under the name Flutep®. Flutep® is a radiopharmaceutical produced by R2 IBF used in Positron Emission Tomography (PET-CT) procedures in the field of nuclear medicine, with application in cardiology, neurology and especially in oncology. In Flutep® the radioisotope used is Fluor-18 (18F), which is produced by bombardment of enriched water (18O water) with protons, which occurs with the use of a cyclotron. Afterwards, an analogous molecule, glucose (deoxyglucose), is incorporated in 18F, giving rise to Fluodeoxyglucose-18F.
TECHNOLOGY
Sao Jose do Rio Preto (Sao Paulo)
The plant features a GE PET trace 16.5 MeV (cyclotron) particle accelerator used for the production of short half-life radioisotopes, of which fluorine-18 is used for the production of the FDG (18F) radiopharmaceutical.
GE's FASTlab synthesis modules, responsible for producing the FDG (18 F) radiopharmaceutical, have their entire process automated and yield up to 70%. The R2 IBF of Sao Jose do Rio Preto has two of these modules, which guarantees up to two syntheses per day, allowing continuous production with high performance and reliability.
Cíclotron
FASTlab
QUALITY AND CONTINUOUS IMPROVEMENT
Sao Jose do Rio Preto (Sao Paulo)
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.
Av. José Abbas Casseb 376
Distrito Industrial Dr. Ulysses Guimarães
São José do Rio Preto - SP
CEP 15092-606 Tel: +55 (17) 3500-4300
