Vaccines, 180 million doses per annum
Fiocruz Instituto de Technologia em Imunobiologicos
Arch Machines Inc., B Braun Biotech, Termo Engenharia Ltda
In 2001, Brazilian Government institute Fiocruz Instituto de Tecnologia em Imunobiologicos completed one of the largest vaccine manufacturing centres in Latin America.
Located in Manguinhos, Brazil, the plant 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 vaccines were added to the facilities repertoire in late 2002. The facility expansion required an investment of $40 million.
The Fiocruz facility is part of an existing vaccine technological complex comprised of a bacterial vaccines production unit, a centre of final processing, and a viral vaccine production unit.
The viral vaccine production plant was later expanded in April 2003 to allow the production of measles, mumps and rubella (MMR) vaccine at the facility.
The Fiocruz complex aims 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 produce 100 million doses of MMR vaccine to vaccinate children in 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 the country.
The contractors for the Fiocruz expansion in 2000 included ARC Machines, 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, while the engineering contractor was Termo Engenharia (TEL).
Industrial site expansion at Manguinhos
The site expansion in 2000 included the construction of a DPT building with 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), 95°C water, and compressed air for cleaning, rinsing and drying activities.
A centre for final processing (CPFI) was also completed (2001) for filling, lyophilisation and packaging of the final products into vials and ampoules. 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.
Premier manufacturer and reference body
The Manguinhos site is managed by Bio-Manguinhos, a technology institute of 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 immuno-biologicals in South America.