industrial policy

Bloody ways

Federal and São Paulo governments plan the installation of a factory of blood byproducts

EDUARDO CESARThe production cost of blood byproducts is similar, regardless of the technology usedEDUARDO CESAR

Every year, Brazil spends US$ 150 million on importing blood by products – proteins obtained from plasma, used in the treatment of diseases like A and B hemophilia and as raw material in vaccines production. The only Brazilian factory, set up in the state of Pernambuco, produces only human albumin and only attends to 7% of the market.Since 2000, the country has been making plans to build a factory to replace imports and to meet the demand from the market. Two rival projects – one from the Union, and the other from São Paulo – are being designed.

The first of them – envisioned in the industrial, technological, and foreign trade policy – is the Brazilian Plasma Fractioning Corporation, now baptized as Hemobrás, with a budget of US$ 60 million. The future company is going to produce human albumin, immunoglobin, prothrombin complex, factor VIII and factor IX – using blood plasma fractioning technology – to attend to part of the demand from the Public Health System in Brazil (SUS in the Portuguese acronym), according to Beatriz Macdowell, the general manger of the area of blood, other tissues, cells, and organs, of the National Health Surveillance Agency. “We are preparing a tender for the transfer of plasma fractioning technology in the country. The blood byproducts factory should be in operation in three or four years”, she foresees.

The second project is from the Butantan Institute, in São Paulo. The São Paulo factory will use chromatography to get blood byproducts, a technology distinct from the one for fractioning plasma adopted by Hemobrás. “It will be the first factory to use this model in the whole world”, guarantees Otávio Mercadante, a director of Butantan. Production by chromatography was “adapted from abroad”, as Mercandante puts it, and “makes possible a greater yield and technological competence”.The project, worth R$ 100 million, is earmarked in the multi-year Plan of the state government, and it may be ready in two years. According to Butantan’s director, this project will have the scale to attend to the whole of the domestic demand, and should be submitted to the Ministry of Health

Discarded plasma
The Hemobrás project started to be drawn up in 2000, when the Ministry of Health carried out a survey and found that, in Brazil, 160,000 liters of plasma was being discarded a year, enough to justify local production. In 2002, two companies were hired, selected by an international competition – one French and the other Austrian – to fraction the plasma gathered in duly selected national centers and transform it into blood byproducts. “It is a question of a passive export for processing raw material with the return of the end product, which works out cheaper”, says Beatriz. This interchange attends to the whole demand of SUS for immunoglobin and factor IX – used on type B hemophiliacs. “But it only accounts for 10% of the demand for factor VIII, intended for the case of type A hemophilia”, Beatriz says. The shortfall is imported.

Hemobrás started to take shape in 2003, when a working group was created to analyze legal aspects, to make the production of blood byproducts compatible with the Federal Constitution, which prevents the marketing of blood in the country. The bill that creates the new factory is now in Congress, and, according to Beatriz, should be approved by November. The factory will not charge the SUS for the product, but it will for the service of fractioning the blood.One part of the resources for the enterprise – R$ 120 million, or US$ 40 million, over four years – is guaranteed in the Multi-Year Blood Plan, drawn up by the federal government. “This guarantees two thirds of Hemobrás”, she reckons. “But the National Bank for Economic and Social Development (BNDES) may come in as a partner and complete the amount of the business”, Beatriz says.

There is also a third technological option – biotechnology – adopted by the majority of the developed countries for producing blood byproducts. Using this process, albumin, prothrombin complex , immunoglobin, factors VIII and IX can be synthesized from recombinant factors, without the risks in processing from contamination that may occur in fractioning plasma. The new technology is being developed by the Brazilian Network for Cloning and Expressing Coagulation Factors, made up of four Brazilian public laboratories. The research, which started in 2001, used US$ 900,000 from the Financier of Studies and Projects (Finep).

“We have now met the basic objectives of cloning and expressing the genes of coagulation factors VIII and IX and cell clones that express reasonable quantities of these factors”, says Dimas Covas, a researcher at the Cloning and Expression Laboratory of the Cell Therapy Center, and a director of the Ribeirão Preto Hemocenter, connected with the University of São Paulo (USP), and the coordinator of the network. The researchers need another US$ 5,000 to carry out tests on other cell strains and on cells modified in bioreactors and to develop new vectors. The construction of the production unit is budgeted at US$ 20 million, and its operation should meet all the demand for blood byproducts in the country, according to Covas.

The production of factor VIII by recombinant DNA technology, for example, currently represents 10% of the total world demand of 2 billion units/year. But the share of the product obtained by biotechnology is growing. “Baxter, from Switzerland, is finalizing the construction of a factory that is going to meet the whole demand”, he says. “The production cost of the unit obtained by plasma fractioning or recombinant factor is practically the same, US$ 0.5 per unit”, Covas reckons. He fears that the country is investing US$ 60 million in a technology – with plasma – that runs the risk of becoming obsolete in four or five years.

Making up the network coordinated by Covas, besides the Ribeirão Preto Hemocenter, are the Cellular and Molecular Biology laboratory of USP’s Chemistry Institute, the Molecular Biology laboratory of the University of Brasilia (UnB); and the Biochemistry and Molecular Biology laboratory of the Federal University of Rio Grande do Sul (UFRGS).