 For the production of combined vaccines, a special unit was built in which follows the rules of Good Practice within Manufacturing.
The packing of the biologic products is performed in a main unit with the capacity to pack 12.000 bottles of doses per hour.
The Butantan Institute was founded by Vital Brazil in February 1901 for the production of antipest serum, in fighting against the bubonic pest epidemy which took place in Porto de Santos (Santos Port)
The sera and vaccines produced in that time, did not follow the rules of quality, safety and efficacy that are required nowadays for pharmaceutical products.
The initial priorities of the Institute were to produce antivenom sera with specificity for serpents of South America.
Since then, the Production Division increases efforts to improve all the manufacturing process, especially of the schemes of equines immunization with the introduction of doubled plastic bags for animal bleeding.
These bags allow the separation of the plasma in a way that blood cells could return to the animal, improving its well-being and consequently a better productivity.
The Butantan Institute through its Biotechnological Unit, developed a new process plan within an internal system, taking into account the Good Practice of Manufacturing (GPM), with capacity to produce up until 1.000.000 ampoules per year.
Besides the production of antitoxic and antivenoms sera, the Institute produce antilonomia serum (a caterpillar that produces a fatal venom), bee antivenom and anti-botulinic serum.
Although all serum has a guaranteed stability, some of them were lyophilized for the Brazilian Army, being able to reach isolated regions of the country, supporting a variation in its conditioning. This is because the installation of a new plan of lyophilizing. In trying to improve the stability of purified serum and also the population growth in urban areas in function of the rural exodus, the demand of the antivenom production has been gradually dropping.
Being so, the Butantan Institute has been offering its sera and its plan for antivenom production to other countries. 
New developed products In collaboration with the Heart Institute of Medicine College from São Paulo University, the Institute has been producing the antithymocytary, obtained through the immunization of equines with thymus cells obtained in infant surgery. This serum is used in cases of acute transplants rejection.
Since 1990, the Biotechnology Unit has been using bioreactors for production in a large scale of monoclonal antibodies.
The anti-CD3, also used in acute transplant rejections, is provided for the Heart Institute of Medicine College from São Paulo University. |
