Report from Brazil March 2013

Published on: 
Pharmaceutical Technology, Pharmaceutical Technology-03-02-2013, Volume 37, Issue 3

Brazil's major vaccine producer innovates with stem-cell research.

In 1898, an outbreak of Bubonic plague struck the port of Santos in São Paulo, Brazil. A year later, a local bacteriological institute set up a unit to produce anti-plague serum in a government-owned farm known as Butantan, which was renamed the Butantan Serumtherapy Institute in 1901.

The institute started gaining global recognition as it ventured into research on animal venom, which consequently led to the production of anti-venom. In 1915, the institute was renamed Butantan Institute. Known as Butantan, the institute currently conducts technical and scientific activities in two major areas—the production of serum and biomedical research.


The institute claims to be Latin America's biggest vaccine producer, with an output of more than 300 million doses every year. Today, Butantan is considered a major contributor to Brazil's public health, having approximately 1700 staff members, including 180 scientific researchers specializing in innovation.

Innovation using Brazilian technology

"I believe Butantan Institute is an important partner to [Brazil's pharma] companies as 80% of all vaccines used in Brazil are produced by this institute," says Irina Kerkis, director of the genetics laboratory at Butantan Institute. Despite its struggles in a globally competitive market, the institute reaches for innovation while balancing research and production according to its researchers.


In its search for local and global recognition, Butantan has developed major research capabilities at its genetics laboratory, including the expertise to retrieve stem cells from milk teeth. Nelson Foresto Lizier, a scientific researcher working at Butantan's genetics laboratory, says that this project is vital given that stem cells have the ability to generate almost any human cell. The study, which is considered the first of its kind in Brazil, is being developed with "100% Brazilian technology" according to Lizier.

The development of the technology started in 2004. It was initially privately funded; however, six years later, investment from major public agencies began pouring in according to Kerkis.

Implications for the pharmaceutical sector

Private pharmaceutical companies in Brazil acknowledge the importance of stem-cell research. "Butantan and the national pharmaceutical industry are major partners and the institute is willing to develop research studies together with the private sector," says Henrique Uchió Tada, executive technical director for the National Pharmaceutical Laboratories Association (Alanac).

According to Tada, the various potential benefits and applications of the stem-cell project include, among others, treatments for diabetes, heart illnesses, liver problems, multiple sclerosis, brain lesions, Parkinson disease, inflammatory diseases, and the recovery of human skin and organs. "However, the development of related pharma products is still a little far away for the national pharmaceutical industry," he adds. Tada explains that stem-cell studies conducted by national pharmaceutical laboratories focus on a type of treatment that is not considered traditional. He says that treatment is obtained through the retrieval of stem cells from the individual's body and not through a synthetic drug applied for treating an entire population with the exact same illness or disease.

Several bioethics experts in Brazil believe that there may be a gap between the pharmaceutical industry and stem-cell treatments. The future might not require the use of drugs as we know them, they say. For example, patients would be able to use their own cells to cure diseases, and as a result, the pharmaceutical industry would be affected because of profit loss from the steep drop in sales. Tada, however, believes that pharmaceutical firms could benefit from stem-cell advances if they develop a method that makes use of stem cells in treatment procedures.

According to both Kerkis and Lizier, the pharmaceutical industry has shown great interest in stem-cell research because of its potential as "biotools" for developing and testing new products. "The development of new drugs through the study of stem cells could become a reality by conjoining findings from pharmacology and cellular biology studies as the variety of substances produced by cultured stem cells could open new doors for pharmacology in general," says Kerkis, whose statement was supported by Lizier.

Butantan's stem-cell research

Embryonic stem cells, obtained by a special technique developed by Butantan researchers, are already being tested in humans. According to the institute, results from these clinical studies, which involve reconstruction of the tissue that covers the human eye cornea for example, are expected to be reported during the second half of 2013.

Butantan's biggest finding is that, through the method developed, it is possible to obtain sufficient quantities of cells to be applied in humans. According to Lizier, one of the advantages of working with stem cells from milk teeth is that these teeth are biological materials that are generally discarded and children have an average of 20 milk teeth that are changed during their lifetime. Moreover, the extraction of the internal material from the teeth is simple and not as painful when compared with other techniques.

With the method developed at Butantan, it is possible to obtain cells that are considered immature compared with other populations of adult stem cells found in other tissues. According to Lizier, the technique uses cells that are similar to embryonic cells, but without the bioethics issues involved or the possibilities of inducing tumor growth during treatments. Using Butantan's technology, researchers can retrieve approximately 100 billion cells from a small fragment of dental pulp. "The figure is big enough for treating up to 100 patients," says Lizier.

Butantan has scientific proof that stem cells from milk teeth could play an important and safe role in treatments involving bone, cartilage, muscle, and neural tissue regeneration as well as in therapies for immune and metabolic disorders and dentistry. As the research develops, other applications of the institute's technology could prove useful in the near future.

—Hellen Berger is a business writer based in São Paulo, Brazil.