The unit will operate under international GMPs and be located within the Butantan Institute*, in São Paulo. "Plasma is the liquid portion of our blood and each country has its own characteristics with different antibodies," explains Elizabeth Martins, scientist and project leader for Butantan Institute. "We live in a tropical country, therefore, we have antibodies raised against diseases found in a tropical environment ... that is why the World Health Organization has asked each country to produce its own blood plasma products, because they are adequate for that specific country," she added.
WHO states that developing countries will only be able to create affordable and sustainable supplies of blood-derived products by using plasma collected from their own population, according to WHO data from Oct. 2009.According to GE, approximately 90% of the blood derivatives used in Brazil are currently imported. Fundação Butantan will produce 30% of Brazil's need, potentially providing a return on investment and running costs within five years.
According to Martins, each country has been asked to be responsible for their own immunobiological products, while another recommendation states that countries should produce their own hemoderivatives.
Top-notch healthcare technology
To date, the São Paulo government has invested approximately R$70 million ($41 million) to build the plant. The Butantan Foundation has spent an additional R$50 million on the engineering project and equipment, says Martins, and will devote more funds to get the plant operational. The facility is being developed with the supporting expertise and technology of GE Healthcare, especially in the area of purifying proteins taken from plasma. The São Paulo government has signed a contract to purchase GE's healthcare technology services.
Martins expects the plant, which should process 150,000 liters of plasma/year, to be operational by mid-2012 with product commercialization to begin in 2013. Bidding has begun among Brazilian firms to develop, according to specific standards, additional equipment and systems.
Why invest in a plasma facility?
From the government's point of view, investment in pharmaceutical production is a key strategy for ensuring that the country is self-sufficient in plasma derivatives and vaccines. With approximately 200 million inhabitants, large volumes of biopharmaceuticals are necessary, and specialists believe it is risky for the country to depend largely on imports of such products.
"Helping drive down cost, improve quality, and increase access to healthcare is our core business strategy," says Olivier Loeillot, Enterprise Leader of Life Sciences at GE Healthcare. "In this project for Butantan, we have brought GE Healthcare's biotechnology, design, and engineering expertise to bear on exactly these key issues in the provision of plasma products to the people of Brazil," Loeillot adds. Part of WHO's call to action is also based on the fact that global healthcare emergencies, such as pandemic swine flu, can greatly affect individual countries' ability to treat its citizens should large volumes of immunobiolocal products become scarce or difficult to obtain.
Moreover, closure of private Brazilian plasma companies in 2001 due to irregularities related with plasma commercialization, which is banned in Brazil, created an urgent need to regain access by establishing a national plasma fractionation facility. Recently, GE's plans for Brazil include additional collaboration between the company and the Brazilian government on various infrastructure projects, including those tied to the World Cup and Olympic Games. According to individuals working on the project, the strategy is to shift focus of key global markets from the US to other countries, especially to emerging markets.
* The Butantan Institute, based in in São Paulo, produces plasma products and vaccines according to strict international standards. The Fundação Butantan (Butantan Foundation) was established in 1985 to promote cost-effective production of vaccines for Brazilians. Butantan is one of the five centers chosen by WHO for its task force to fight disease around the world. The institute produces more than 50% of the vaccines used in Brazil and 80% of all vaccines used in the national vaccination program. With a surplus production capacity and a strong research and development program, Fundação Butantan has attracted international projects in biologicals.
Hellen Berger is a freelance writer based in Brazil.