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Guarantee of life

A bio-medicine for babies will be produced on a large scale

MIGUEL BOYAYANA newly born: full breathing using the surfactant MIGUEL BOYAYAN

A bio-medicine produced at the Butantan Institute in partnership with the food company Sadia, which has as its raw material pigs’ lungs, should avoid the deaths of around 50,000 recently born children per year, victims of the Infant Respiratory Distress Syndrome (RDS). The disease, typical of premature babies, is caused by a deficiency of a pulmonary surfactant, a substance that forms in the lungs of babies at the end of pregnancy and which serves for the complete working of the respiratory system. Produced naturally by the lungs, the surfactant acts upon the interior of the alveoli, allowing them to remain open during breathing. The shorter the pregnancy time, the greater the incidence of RDS. Treatment is carried out with the application of the surfactant in the baby’s trachea, shortly after birth. A dose of the imported medicine costs R$ 700.00, which makes its distribution to the Public Health System unviable. This is a problem that is beginning to decrease with the manufacture on a large scale of the first surfactant produced with national technology starting from pigs’ lungs, with a cost forecast to be around 40% to 50% that of the imported medicine.

Currently the Butantan Institute is producing 4,000 doses per year. The goal is to reach 200,000 per year. For this, Sadia, which sends the pigs’ lungs in refrigerated trucks to the institute, it going to take charge of the process’s first phase, the extraction of the surfactant. A 40-square meter area was set up by the company at its unit in the town of Uberlandia, in the state of Minas Gerais , where 500 kilograms of pigs’ lungs will be prepared per week. Initially they will be washed and minced. After the mincing, a salt solution is added to the lungs, which is afterwards filtered. Next cellulose, responsible for the absorption of the surfactant, is added to the mixture. Instead of sending the lungs to Butantan, the company will send per week 300 kilograms of cellulose with the surfactant. The other two stages, purification and lyophilization, will be the responsibility of the Institute.

The research that initiated the production of this medicine began back in 1997 and has resulted in new extraction technology of the pigs’ lung surfactant, which substitutes the use of high speed centrifuges using a type of paper called DEAE cellulose (see Pesquisa FAPESP No. 70). After having completed all of the pre-clinical test phases, last year the clinical trials for the validation of the medicine were initiated, covering 33 institutions throughout Brazil. The tests are forecast to end in the middle of this year, but the results so far show that both the imported surfactant and the national surfactant are equally efficient. “The quantity of the product necessary for the survival of the children is also the same” says Isaias Raw, the president of the Butantan Institute Foundation.

The coordination of the clinical tests is under the responsibility of the Children’s Institute  of the Hospital das Clínicas of the Medical Faculty of the University of Sao Paulo (USP). Right from the start the research was able to count upon financial support from FAPESP. The most recent project is a thematic project also financed by the Ministry of Health within a convention signed during 2005. During the first phase, all of the bio-medicine production will be distributed to the public maternity hospitals in the country.

The Project
Industrial development of  a pulmonary surfactant  of animal origin
Thematic Project
Isaias Raw – Butantan Institute
R$ 1,062,917.31 and  US$ 193,000.00 and € 145,000.00 (FAPESP and the Ministry of Health)