REDBIO México 2010

Folio: 359
Tipo de presentación: Cartel
Tema: Bioseguridad

Biopharmaceuticals: the Challenge of Innovation and Safety of Recombinant Technology Products

Ana Luiza Vivan 1*, Rutnéia de Paula Pessanha 1, Pedro Canísio Binsfeld 1

RESUMEN (ABSTRACT)
"Biopharmaceuticals are medical drugs produced by recombinant technology. They are proteins, including antibodies, nucleic acids used for therapeutic or diagnostic purposes. The safety of these products stills a major challenge. The association between industries and academies can leads to economic development and self-sufficiency in this area in Brazil. The genetic engineering techniques have promoted direct manipulation of genes in living organisms. The recombinant DNA technology allowed the expression of pharmacological drugs in an industrial scale of microorganisms like bacteria or yeast. Currently in Brazil, there is an increase of initiatives for innovative biological drug development. This production involves research, industrial scale up and development, formulation and marketing. These phases are driven by private and public interactions. The production of recombinant proteins as vaccines and biopharmaceuticals involves the use of genetically modified organisms. Thus in Brazil, any industrial research and development of recombinant drugs must first be analyzed and approved by the National Biosafety Commission. This commission was created by the Law 11.105, on March 24, 2005, and supplemented by Decree 5.591, on November 22, 2005, that defines the biosafety conditions for GMO manipulation. The sanitary aspects are regulated by the National Agency for Sanitary Surveillance. The main biopharmaceuticals produced by genetic engineering used in the Unified Health System, are erythropoietin, imiglucerase, filgrastim, molgramostima, alteplase, interferons, insulin and some recombinant vaccines. The development of new innovative and safe drugs is strategic to reduce the vulnerability and increase the access to diagnostic, preventive and therapeutic treatments of the whole Brazilian population."