History: 2010 till nowadays

folha-tabaco-plataforma-vegetal-100x1002010

Bio-Manguinhos signs agreement of inactivated yellow fever vaccine with the Fraunhofer to develop the vaccine from a vegetable platform.
The Institute signs a contract for technology transfer of the rapid test Dual Path Platform (DPP®) to diagnose syphilis. Records for three products are obtained: rotavirus vaccine, confirmatory test for HIV-1/2 and Nucleic Acid kit (NAT) for HIV and HCV (hepatitis C). Concerning the pentavalent vaccine, which protects against diphtheria, tetanus and pertussis (DTP), Haemophilus influenzae b (Hib) and hepatitis B, had their clinical studies completed.

 

selo-comemorativo-bio-manguinhos-35-anos

2011

As part of the schedule to celebrate the 35th anniversary of the foundation, Bio-Manguinhos promotes the II International Symposium of immunobiologicals. Renowned experts in biotechnology have gathered to discuss the future of Brazilian and worldwide health in the area of vaccines, biopharmaceuticals, reagents for laboratory diagnosis and regulations. It is signed a contract with the company Sanofi Pasteur, which make it possible for the unit to provide and, subsequently, to produce the inactivated polio vaccine.

In a ceremony with the President Dilma Rousseff and the Minister of Health, Alexandre Padilha, in Rio de Janeiro, it is signed the official term of cession of a plot of 580,000 m2, in Santa Cruz (Rio de Janeiro). On the site, it will be built the new Center for Final Processing (NCPFI) of the unit. While the industrial plant, which will produce immunobiologicals from plant platforms, is under construction, it will be occupied 225,000 m2 in the Industrial Pole of Health, in Eusébio County (Ceará).

Five rapid tests are introduced with the technology Dual Path Platform (DPP®), which assures faster, accurate and safe results: syphilis, canine visceral leishmaniasis, immunoblot HIV-1/2, leptospirosis and screen HIV-1/2. The project “Growing up with Manguinhos”, from the Socioenvironmental Responsibility Commission (add) meet 86 people from neighboring communities, among youngster and their families. 

 

plenaria-extraordionaria-100x1002012

Bio-Manguinhos obtains authorization, by representatives from all units of the Foundation, to create a federal public company.

In his fifth participation in the Rio Quality Award (PQRio), Bio-Manguinhos conquers the silver category, in the evaluation that recognizes public and private organizations in the state that stood out for excellence in the management model.


vacinas-pni-100x100The Institute provides to the National Immunization Program (NIP) more than 103 million doses of vaccine and exported 10 million to UN agencies.

From the second half of the year, the institute initiates the supply of viral tetravalent vaccine. Combined with the MMR, the new vaccine will immunize against measles, mumps, rubella and varicella (Chickenpox).

It is created the page Bio on Facebook, representing a further means of communication with its various public interest.

 

ncpfi-100x100The construction of two Bio-Manguinhos new campuses in Santa Cruz (RJ) and Eusébio (CE) began; the executive project of the New Final Processing Center for Immunobiologicals (NCPFI) that will be located in the west zone of the city of Rio de Janeiro. In addition to the environmental impact assessment of the land was completed; the preparation of the construction site began and it was ratified the commitment of the government of Ceará state about the grant of the land for the new Fiocruz campus.

 

 

 

assinatura-pdp-100x100

2013

Through technology transfer with the Israeli company Protalix, Bio-Manguinhos will produce the biopharmaceuticals alfataliglicerase, which combat the Gaucher disease. In addition, the Institute has signed 10 intentions of partnership for productive development (PDP), besides the partnership with the Bill and Melinda Gates Foundation, for the first phase of clinical studies aiming at the development of the double viral vaccine (measles and rubella).

It is granted scientific cooperation with the pharmaceutical company Sanofi Pasteur and partnership with Butantan Institute and Funed to develop the heptavalent vaccine (DTP, HIB, Hepatitis B, hepatitis B, polio inactivated).

heitor-beltrao

Is opened in June the Coordinator Center of Clinical Researches Heitor Beltão, in Tijuca, where Bio will conduct their clinical research.
The unit receives the visit of the President of Opas, Carissa Etienne, who came to know the project of NCPFI.



diretora-opas-2-100x100The unit was visited by Carissa Etienne, president of OPAS, who learned about the new CPFI project. Brazil was her first destination after her inauguration on February 1st.

 

 

 

 

lab-dengue-100x100

2014

At the new laboratory of dengue fever, it will be analyzed all samples of epidemiologic and clinical studies conducted in Brazil, Mercosur and Asia.
The test for diagnosing DPP® HIV-1/2 was used for serological screening by means of a drop of blood, serum or plasma. From 2014, it was possible to use oral fluid as well.

The Institute has succeeded in obtaining the records of the alfataliglicerase and rapid test DPP® Syphilis DUO.

The kit NAT, which detected HIV (AIDS virus) and HCV (hepatitis C virus), now has a new target, the HBV (hepatitis B virus).

fundacao-gates-100x100

The partnership between Bio-Manguinhos and the Bill and Melinda Gates Foundation for the production of the double viral vaccine (measles and rubella) competed for the Award of Excellence of the vaccine industry, organization Vaccination, in the category of best partnership.

 

 

akira-homma-20-influente-do-mundo-vacinas-100x100

Akira Homma is elected as one of the most influential people in the vaccine industry. The President of the Political and Strategic Council of Bio-Manguinhos (CPE) won the 20th position.

 

 

  

assinatura-betainterferona2015

Signing of contract of technology transfer, the biopharmaceutical Beta interferon 1a, indicated for the treatment of multiple sclerosis, with companies Merck and Bionovis.

 

Start of the clinical study phase I of the double viral vaccine (measles and rubella).

 

Renewal of the certificate of GMP, by Anvisa, for the lines of vaccines and biopharmaceuticals.

Obtaining of the register of three products: rapid test DPP® HIV/Syphilis, the infliximab and tetraviral vaccine.

reflorestamento-cibs

Industrial Complex of biotechnology in health (CIBS) in Santa Cruz: beginning of the planting of 30,000 seedlings of native trees of the rain forest to form the green belt around the ground. Preparation for the step of stem cutting and beginning of the 2nd phase of landscaping.

With the expansion of the CPFI, the ability of the formulation of vaccines will grow by 200%. The aseptic simulations are planned to begin in February.

 

 

 

 

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History: 2000-2010

exportacao-febre-amarela-2001-100x1002001
In September, it conquers the National Certification for Good Manufacturing Practices (GMP) of the yellow fever vaccine, issued by the National Health Vigilance Agency (Anvisa), crucial step for the international qualification. In October, the unit receives the qualification from the World Health Organization to act as an international provider of this product, an unprecedented fact in the area of vaccine production in Brazil.  Start of production of the combined vaccine of DTP and Hib (50 doses per cartridge), in partnership with the Butantan Institute. Start of construction of the Production Center of Viral Antigens (CPAV) and the Production Center of Bacterial Antigens (CPAB) in Bio-Manguinhos.

 

2002
New presentation of the DTP/Hib vaccine with 25 doses per cartridge.

 

2003
Signing of the agreement for technology transfer of the Measles Mumps and Rubella vaccine (MMR) with GlaxoSmithKline. Until then, this was the only imported vaccine present on the Brazilian basic vaccination schedule. Implementation of the Professional Master Degree in technology of Immunobiologicals in Bio-Manguinhos (partnership with Oswaldo Cruz Institute). 

 

recorde-vacinas-20042004

The unit sets a new record of yellow fever vaccines exportation: more than 26 million doses against around eight million from the previous year.
Bio-Manguinhos deals with Cuba for technology transfer for production of the biopharmaceuticals human recombinant alphapoetin and erythropoietin and human recombinant interferon alpha. Luiz Inácio Lula da Silva, President of the Republic at that time, opens the Production Center of Bacterial Antigens (CPAB), responsible for the national production of conjugate vaccine for Haemophilus influenzae b (Hib). Technology transfer agreement of rapid test for HIV diagnosis with the Chembio Diagnostics Inc.

 

vacina-hib-20052005

In May, it completes the cycle of national production of Hib vaccine - whose technological transfer was agreed in 1999 with the GlaxoSmithKline: three lots of product's consistency, used for clinical studies of non-inferiority were produced.

The new rapid tests for diagnosis of HIV 1 and 2 are made available to the Department of STD, Aids and Viral Hepatitis.
Certification for Good Manufacturing Practices (GMP) for all vaccines and diluents.

 

bio-manguinhos-fiocruz-30-anos2006

Bio-Manguinhos celebrates its 30th anniversary and performs the I International Symposium of Immunobiologicals and human health. On occasion, it is signed the Ordinance which establish the National Program for Competitiveness in vaccines (Inovacina). The program is an initiative of the Brazilian industrial production sector of vaccines to achieve self-sufficiency in immunobiologicals of the annual vaccination schedule.
Conclusion of the works of the Konosuke Fukai Center, which reunites the new facilities of the Production Center of Viral Antigens (CPAV) and the Quality Center (CQUAL). Start of construction of the Center Henrique Penna (Prototypes, Biopharmaceutical and Reagents for Diagnosis).

Bio-Manguinhos receives the Rio Quality Award (Silver), being the first institute linked to the Ministry of Health and the first technical unit of the Fiocruz to win this award.

Start of Phase I of clinical studies of the vaccines meningococcal meningitis serogroup B, and serogroup C conjugate. Certification for Good Manufacturing Practices (GMP) for diagnostic products for in vitro use.

 

comissao-responsabilidade-socioambiental-somar

2007

It starts to produce the vaccinal concentrate of the Haemophilus influenzae b vaccine.

I order to meet the request of the World Health Organization, the Institute signs an agreement with Cuba for supplying of meningococcal AC vaccine, aiming to combat the risk of an epidemic in African countries.

cipbr-2007

In July, Bio-Manguinhos, the Brazilian Development Bank (BNDES), the Secretariat of Science, Technology and Strategic Inputs and the Secretariat of Health Surveillance subscribed a funding to enable the construction of CIPBR.

presidente-lula-visita-inauguracao-cpav-2007

The President of the Republic, Luiz Inácio Lula da Silva, opens the Production Center of Viral Antigens of Bio-Manguinhos (CPAV), with capacity to produce approximately 100 million doses of the Measles, Mumps and Rubella vaccine (MMR).

dcvmn-2007-ricardo-galler

Bio-Manguinhos organizes the 8th Annual Meeting of the Network of Vaccines Producers in Developing Countries (DCVMN). The Institute currently chairs the network, being member since its creation.

 

inauguracao-konosuke-fukai-20082008
On July 11th, it is opened the Konosuke Fukai Technological Center, in homage to the Japanese researcher of the same name, who contributed to the strengthening of technological expertise in the production of viral vaccines, such as measles and poliomyelitis in Bio-Manguinhos.

 

 

diretor-artur-roberto-couto-posse-20092009
On May 25th, anniversary of the Fiocruz, Artur Roberto Couto takes office as director of Bio-Manguinhos after being elected with 91% of valid votes.  In August, Bio-Manguinhos and GlaxoSmithKline sign two agreements. The first to the introduction of the pneumococcal vaccine in public health system; while the second seeks to accelerate the search for new products, stimulating the exchange of scientific and technological experiences to develop dengue fever, yellow fever and malaria vaccines.

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History: 1990-2000

1997

Implementation of a new management model in Bio-Manguinhos, focused on evaluating the results, autonomy, self-sustainability, agility and operational flexibility. Establishment of a term of commitment of management between Fiocruz and Bio-Manguinhos and of a new organizational structure, highlighting the implementation of the Superior Council of Administration.

 

1998
Opening of the Center for final processing of Immunobiologicals (CPFI), which is part of the Industrial Complex of vaccines of Bio-Manguinhos. This enabled the institution to attract new international technologies for vaccine production.

 

1999
Start of production of the vaccine Haemophilus influenzae b (Hib), through technology transfer agreement between Bio-Manguinhos and SmithKline Biologicals, whose initial phase is the production of the vaccine from bulk (concentrate antigen) imported from Belgium, performing the formulation, bottling, lyophilization and the final processing of the vaccine.

 

2000
Signing of the contract for technology transfer of the rubella vaccine among Bio-Manguinhos/Fiocruz and the Biken Institute, Japan.

 

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History: 1980-1990

1982
Inception of the production of the Measles vaccine, through technological cooperation with the Biken Institute from Japan. Bio-Manguinhos implements, for the first time in Brazil, a complex technology of tissue culture and lyophilization in industrial scale, including the entire production cycle of a viral vaccine for human use.

 

1983
Inception of production of the oral trivalent poliomyelitis vaccine, using technology provided by the Japan Poliomyelitis Research Institute. This production involves the activities of formulation and final processing of the vaccine, from viral concentrate imported from the Biological Products Division of the company SmithKline Beecham.

 

1985
Launching of the National Program of Self-sufficiency in Immunobiologicals, which aims to put an end to the dependence of importation of serums and vaccines, through investment in laboratories and industrial plants to meet the demand of the immunization public programs.

 

1986
Production and availability of three types of poliomyelitis vaccine, due to the outbreak of the disease in the Northeast region: the monovalent of poliovirus III; the poliovirus I, II and III; and the poliovirus I, II and III with reinforcement of type III - specially developed to control this outbreak. From this study, the World Health Organization adopts the poliovirus I, II and III with reinforcement of type III to tropical countries.

 

1990
Start of construction of the Technological Complex of Vaccine of Bio-Manguinhos, on the campus of the Fiocruz, in Rio de Janeiro 

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