Abstract

Currently, production of vaccines and diagnostic systems for infectious diseases has failed to provide a systematic vision that merges state-of-the-art technologies with industry to provide an effective commercial solution. Infectious and rapidly transmitted diseases, such as cancer, Ebola and influenza, should be a focus of interest for these prospects. While technological advances of recent years have been revolutionizing the life sciences industry, specifically in the biopharma field, these advances have been disproportional in terms of their applications towards infectious diseases. Working on the development, recombinant technology is needed for the production of chimeric proteins using mammalian, yeast, and bacterial cells modified for those purposes. Proteins developed through a process of molecular engineering, which begins with in silico bioinformatic processes, using validations and algorithms, subsequently through synthetic biology, molecular biology, genetic engineering, and Bioprocess development. The aim being, the scaling efforts towards pilot plant levels. The primary goal of these proteins is the development of integrated solutions that can be used as antigens or antibodies in diagnostic systems, as well treatments and vaccines. The main challenge is in the final application that results in the free exposure of epitopes for recognition between the antibody and the antigen of interest, which implies their effectiveness in terms of use. A secondary challenge is productivity rates in bio-production systems, which vary greatly depending on the platform used and the quality of the bioprocess developed. The recombinant proteins HA-RBD, tAg, scFv-13F6, scFv-13C6 and Fab-KZ52 were designed, developed, expressed and characterized by the integral use of molecular engineering and bioprocess engineering. The expressed proteins showed biological antibodies (HA-RBD and tAg) and antigen (scFv13F6 and scFv-13C6) recognition, recognizing specific epitopes. Significantly tAg production occurred with a yield of 50 mg L-1 and HA-RBD protein was produced in 120 mg L-1