Development of bioprocess for the production of purified protein derivative with Brazilian strains of Mycobacterium tuberculosis for diagnosis use

Tuberculin, a purified protein derivative (PPD), when diluted in adequate concentration it is utilized for an early detection and to control tuberculosis. In Brazil, the PPD is imported and distributed by the Health System in all Brazilian regions. This, in addition to eventual delay in delivery caused by the legal import process, makes difficult the access of the product to poor communities from distant places as Brazil is a geographically a large country. Thus, indigenous production of PPD would be very beneficial for the society. This work was undertaken with a view to initiate studies towards the development of an indigenous technology for PPD production, using the strains of Mycobacterium tuberculosis isolated from patients during the course of disease from several regions of Brazil. The strain selection criteria for PPD production were the sequencing of three immunodominant proteins and the genetic differentiation by DNA fingerprinting and grouped by UPGMA program, the capacity of protein production in liquid medium, and finally the intradermal injection tests used on animal model. Compared to gold standard, the PPD showed similar indurations when tested individually, and better results were obtained when products were combined in pool. These strategies are discussed in detail in this research.