Industrial Production for Healthcare
With a production area of approximately 2,000m², the Molecular Biology Institute of Paraná (IBMP) acts strategically in the epidemiological surveillance of the Brazilian Unified National Health System (SUS) by means of the development of molecular diagnostics solutions. Since 2011, IBMP has held the Good Manufacturing Practice (GMP) certificate granted by the Brazilian National Agency of Sanitary Surveillance (ANVISA).
The products supplied to SUS include the amplification module of the HIV (Aids), HCV (hepatitis C) and HBV (hepatitis B) NAT Kit , assuring the transfusion safety and efficacy of the Brazilian blood donation network. The NAT for differential diagnosis of zika, dengue and chikungunya viruses is currently at the implementation phase.
For the near future, IBMP works to offer a range of products for diagnosing prenatal and neglected diseases, cancer,sepsis, and biopharmaceuticals with emerging demands.
HIV/HCV/HBV NAT Kit
This test detects the AIDS,hepatitis B and C viruses, assuring the quality of the blood donated in the Brazilian public blood network, which employs an automated platform with high processing capacity, allowing simultaneous analysis of up to 552 blood bags, with high traceability and sensitivity. IBMP was involved in the development of the test and the production of the amplification module of the kit, which is distributed to SUS by Bio-Manguinhos, the Immunobiological Technology Institute of Fiocruz.
BIOMOL Kit for Zika, Dengue and Chikungunya
Currently in licensing process, this molecular test will provide differential diagnosis of three diseases transmitted by the Aedes aegypti mosquito. Product of a collaborative effort of IBMP and four Fiocruz units, the new technology, besides helping to identify the diseases, which have similar symptoms, will have a lower cost when compared to imported diagnostic kits.
Molecular Diagnostic Kit for Malaria
This product is made using the gelification technology during its manufacturing process. It detects the presence of different Plasmodium species, the parasite that causes malaria. The kit reduces transportation costs and cross contaminations as well. Headed by IBMP, this initiative is a partnership with the U.S. Centers for Disease Control and Prevention (CDC).
Module for Detection of Cyclospora cayetanensis (for research use only).
The etiological agent of an intestinal disease that causes severe diarrhea, Cyclospora cayetanensis is a single-celled coccidian that infects humans by the consumption of contaminated food or water. IBMP supplies the U.S. Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) the molecular test for detecting cyclosporiasis, based on a reaction to detect the DNA of the parasite.
Reagents for Real-Time PCR
The Polymerase Chain Reaction (PCR) technology is applied in studies for developing and validating diagnostic kits for specific detection of clinically important molecular targets, meeting the demands of the Ministry of Health for the Epidemiological Surveillance Network. IBMP’s production in this area is based on the nationalization of the Influenza A/H1N1 NAT Kit.
Production of oligonucleotides
Part of a project to nationalize the production of reagents for strategic molecular tests for the Brazilian public health system, IBMP synthesizes oligonucleotides for research purposes, an important component of molecular tests. The initiative reduces delivery time at costs equivalent to market prices.