Bio-Manguinhos: Partnership for the world public health The Immunobiological Technology Institute - Bio-Manguinhos is the biggest and most modern federal laboratory for R&D and production of immunobiologicals and IVD reagents in Brazil – the South America’s leading economy, with a population around 203 million people. This technical-scientific unit of the centenarian Oswaldo Cruz Foundation (Fiocruz/MOH) plays a strategic role in the supplying of a range of pediatric vaccines for around 3 millions of newborns per year, besides biopharmaceuticals and IVD reagents, mostly for the Brazilian public health system. Bio-Manguinhos Immunobiological Technology Institute CONTACTS [email protected] Tel +55 21 3882-9383 Castle of Fiocruz Bio-Manguinhos presents high performance in the production sector, as well as in research and development aiming to create new products and technologies, knowledge and economic benefits to the country. Besides the autochthonous development with a high skilled team, the Institute has a vast experience with national and global partnerships for co-development and technological transfer processes. Currently, Bio-Manguinhos has important public-private partnerships ongoing with a view to the provision of new biotech products to the population. Africa Asia Central America, Noth America and Caribbean South America Oceania Bio-Manguinhos also exports vaccines prequalified by WHO for more than 70 countries worldwide, according to United Nations Agencies request. Immunobiological Technology Institute | Bio-Manguinhos/Fiocruz Av. Brasil, 4.365 - Manguinhos - Pavilhão Rocha Lima CEP: 21040-360, Rio de Janeiro, RJ www.bio.fiocruz.br | www.facebook.com/BioFiocruz Pictures: Ascom Bio-Manguinhos / Guido / Peter Ilicciev Partnerships for the World Public Health The Bill & Melinda Gates Foundation established a strategic alliance to prioritize the development of solutions for pressing global health issues. During the 9th Grand Challenges Meeting, the agreement between the Bill & Melinda Gates Foundation and Bio-Manguinhos was announced for the production, development and export of the vaccine protecting against rubella and measles. The vaccines produced will be distributed in developing countries of Africa, Asia and Latin America, serviced by the Global Alliance for Vaccines and Immunization and by institutions of the United Nations (UN). The expectation is 30 million doses per year to be available in the market from 2017. The initiative will rely on US$ 1.1 million of the Bill & Melinda Gates Foundation. “We’re both optimists. We believe by doing these things - focusing on a few big goals and working with our partners on innovative solutions we can help every person get the chance to live a healthy, productive life.” ( text from the letter written by Bill and Melinda Gates to partners.) Bill Gates and Melinda Gates New areas Brazil CIPBR • • • • Butantan Institute Federal University of Rio de Janeiro (UFRJ) Fiocruz Units Molecular Biology Institute of Paraná (IBMP) USA • • • • Chembio Fraunhofer Luminex Bill & Melinda Gates Foundation England • GlaxoSmithKline (GSK) Cuba • Cimab • Finlay Institute • Heber Biotec Multi-purpose plants Following the Good Manufacturing and Laboratory Practices The Integrated Centre for Prototypes, Biopharmaceuticals and Reagents for Diagnosis (CIPBR) is one of the largest investments in innovation and technological development in the country. • Modern technology platforms for the large scale production of biopharmaceuticals and reagents for diagnosis to meet the demands of the Ministry of Health. • 1st pilot plant in Brazil with characteristics of GLP, GMP and Bio-safety with the aim to bridge the innovation gap, and to support internal and external projects, both at the national and the international level. • Platforms with simultaneous and independent operations. Germany Santa Cruz Campus I RJ France With a planned funding of BR $800 million from the Ministry of Health, the Bio-Manguinhos New Secondary Operations Facilities will expand the supply of Immunobiologicals for the entire country. The venture, which will be built in an area of 580,000 m², is under construction and will be designed to be one of the most modern biotechnology centres in the world. At the site, 120 million • Qiagen • Sanofi Pasteur ISRAEL • Protalix Industrial Biotechnology Center vaccine vials can be produced annually, in addition to biopharmaceuticals, according to the product mix. Integrated Center for Prototypes, Biopharmaceuticals and Reagents for Diagnosis With this new biotech centre it will be possible to Incorporate in state-of-the-art technologies and international Obtain certifications from regulatory Authorities such as the WHO, the Food and Drug Administration (FDA/USA) and the European Medicines Agency - which will enable Immunobiologicals Brazil to supply globally. •D iphtheria, Tetanus, Pertussis and Haemophilus influenzae type b • Haemophilus influenzae type b • Measles, Mumps and Rubella • M easles, Mumps, Rubella and Varicella (MMRV) • Oral Poliomyelitis • Inactivated Poliomyelitis • Rotavirus • 10-valent Pneumococcal • Polysaccharide Meningitis AC • Yellow Fever EUSÉBIO Campus I Ceará Plant-based Technology Center Bio-Manguinhos began to invest in building a new campus for plant-based technologies. The new Plant-based Technology Center will be located at the Fiocruz Ceará Campus inside Industrial and Technological Health Pole in the city of Eusébio. With around 225,000 m², the new site will have facilities dedicated to host on going and future partnerships for the development and production of plant-based vaccines and biotherapeutics. The new site is being designed based on modern bioprocess technologies, construction strategies, sustainability and compliance to all GMP, GLP and Biosafety regulations. Industrial Biotechnology Center • • • • Imunoblot DPP® HIV-1/2 DPP ® HIV-1/2 DPP ® Syphilis DPP ® Canine Leishmaniasis DPP ® Leptospirosis Prokaryotic expression Eukaryotic expression Conjugation Plant based Rapid Tests Flow Cytometry Microarrays Molecular Assays Biopharmaceuticals • Monoclonal Antibodies • Therapeutic Proteins • Molecular Biology: • Rapid Test: Vaccines IVD Reagents IVD Reagents NAT HIV/HCV Core business • • • • Portfolio Vaccines perspective alliance for immunization Partners • ELISA/IFA: Chagas Disease IFA Canine Leishmaniasis ELISA Human Leishmaniasis IFA perspective Innovation in global health Plant-based Technology Center • Kato-Katz Method: Helm Test Biopharmaceuticals • Interferon alpha 2b • Erythropoietin • Alphataliglucerase www.bio.fiocruz.br
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