ASPECTOS FUNDAMENTAIS À IMPLANTAÇÃO DA TECNOLOGIA DE PRODUÇÃO DE ANTICORPOS MONOCLONAIS HUMANIZADOS COM POTENCIAL APLICAÇÃO TERAPÊUTICA

Monoclonal antibodies (Mabs) have several applications in transplants, reagents for diagnosis, a great variety ofauto-immune diseases and mainly, in cancer therapy. Mabs production employing recombinant echnologymade a revolution in immunoglobulinsgeneration, enabling the production of humanized antibodiesthat recognize specific antigens. The low selectivity of the current techniquesfor neoplasm diagnosis and therapy is one of the major impediments for oncology practice. In this regard, the use of eneticallyengineered immunoglobulins has become a reality and meansa strategic development comprising around 25% of the global biopharmaceutical market. This work shows the most important aspects in Mabs humanization through complementary determining regions (CDR) graft methodology, emphasizing a proposal ofanti-CD20 Mab production against non-Hodgkin lymphoma. Introducing the Instituto de Tecnologia emImunobiologicos – Bio-Manguinhos in this important and promising biopharmaceutical market through the establishment of humanization methodology is the main object of this dissertation. Making humanized Mabs production feasible is veryimportant not only for the earlyand precise identification of illnesses, but also to meet a demand of the Brazilian market that still lacks comprehensive and efficient treatment. The study of Mabs, their structureand properties, expression systems, cultivation, purification, new dimensions and structure of the laboratory, partnerships, cooperation,human resources and market analysis are considered herein.