Fiocruz Vaccine Manufacturing Centre, Manguinos, Brazil

Brazilian Government institute Fiocruz Instituto de Tecnologia em Imunobiologicos completed the largest vaccines manufacturing centre in Latin America in 2001. The plant in Manguinhos, Brazil, is capable of processing 180 million doses per year of vaccines against yellow fever, smallpox, tuberculosis, typhoid fever and measles. Diptheria, Pertussis and Tetanus vaccine (DPT) and meningitis AC vaccines were added to the facilities repertoire in late 2002. The facility expansion required an investment of $40 million.

VACCINE FACILITY

The Fiocruz facility is part of an existing vaccine technological complex comprised of three main buildings: the bacterial vaccines production unit, the centre of final processing and the viral vaccine production unit. The viral vaccine production plant is being expanded again as of April 2003 to allow the production of MMR vaccine at the facility. The purpose of the Fiocruz complex is to meet the Brazilian public's demand for vaccines and to supply new international markets with surplus vaccines and hyperimmune sera.

FIOCRUZ AND GLAXOSMITHKLINE (GSK)

Fiocruz has striven to develop a capability to produce vaccines in bulk quantities and form partnerships with large multinational pharmaceutical companies in order to serve the global market. To achieve this objective, the institute placed emphasis on good manufacturing practices (GMP) standards.

In April 2003, Fiocruz and GSK signed a technology transfer agreement (to begin in 2004) to produce 100 million doses of Mumps, Measles and Rubella (MMR) vaccine to vaccinate the child population of Brazil. The technology transfer will occur over a period of five years and Fiocruz will manufacture the vaccine in Brazil and be responsible for its commercialisation in Brazil only.

CONTRACTORS

The contractors for the Fiocruz expansion in 2000, which was completed in 2001, included: ARC Machines Inc, which provided orbital welding equipment for the fabrication of the vaccine production facility; the bioreactors were supplied and installed by B Braun Biotech of Germany; the engineering contractor was Termo Engenharia Ltda (TEL) (this was the company concerned about the welding achieving the FDA and INCQS (Institute National Controle Qualidade Sanitaria) standards).

INDUSTRIAL SITE EXPANSION AT MANGUINHOS

The site expansion in 2000 included the construction of a Diptheria, Pertussis, Tetanus (DPT) building (included a class 100,000 fermentation room), which was designed for producing bacterial vaccines. Piping was also installed for delivering chilled water, deionised (DI) water, water for injection (WFI), water at 95°C and compressed air for cleaning, rinsing and drying activities.

A centre for final processing (CPFI) was also completed (2001) in which filling, lyophilization and packaging of the final products into vials and ampoules could be carried out. In addition, many utility buildings supporting the infrastructure were constructed, including a building for water treatment (which processes water into deionized water), one for chilled water and another for steam generation.

BIO-MANGUINHOS: PREMIER MANUFACTURER AND REFERENCE BODY

The site at Manguinhos is managed by Bio-Manguinhos, which is the institute of technology on immunology created by Fiocruz. A public organisation, it is recognised as the largest Brazilian manufacturer of immunobiological drugs and is considered one of the major technological reference bodies for immunobiologicals in South America.

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