Science communication from the Center for Translational Science and Development of Biopharmaceuticals

Abstract

Technological advances continually emerge to improve the discovery, rational modification, production and purification of biopharmaceuticals. The identification of different species of microorganisms from Brazilian biodiversity, using innovative strategies, should be carried out with a view to discovering alternative hosts for heterologous expression. The Center for the Study of Poisons and Venomous Animals (CEVAP) - UNESP's Translational Research Unit - has been prospecting and developing candidate molecules for the production of biopharmaceuticals since its foundation. Two bioproducts called respectively "Fibrin Sealant" and "Anti-Apile Serum" were developed by our team and have already crossed the "Valley of Death", awaiting investments for phase III clinical research and subsequent registration with ANVISA for their distribution in the System network. Health System (SUS). To meet the last stage of phase III research, the product requires Good Manufacturing Practices. To overcome this challenge, the researchers submitted to the Ministry of Health the construction of the Biopharmaceuticals Pilot Batches Factory for Clinical Research, unique in Latin America, which was approved and tendered by UNESP in August 2021 in the amount of R$ 12,222,222.20 . This Factory-School will meet internal demands, from other research institutions in Brazil, as well as from abroad, as it will function as a CDMO (Contract Development and Manufacturing Organization). The Translational Science and Biopharmaceutical Development Center proposed in this project, in addition to providing continuity to existing products, will develop and implement platforms for prototyping recombinant molecules for a new fibrin sealant 2.0 to improve its performance as a healing agent; research and produce mono and polyclonal antibodies against Sars-Cov-2, and finally implement a platform for serological diagnosis against COVID-19 based on recombinant antigens. The technologies for producing antibodies and serological diagnosis could be transferred to other viral diseases given the versatility and applicability of the proposal. To make the project viable, applicants from UNESP (headquarters unit), USP and Institutos Biológico, Adolfo Lutz and Emilio Ribas (partner institutions), in addition to foreign collaborating institutions, will put their best efforts into achieving the established goals and realizing the projects and proposed subprojects. We will also have the participation of visiting researchers from KU Leuven in Belgium, and SRM University Delhi-NCR in India. In this way, the dissemination of scientific advances within the academic community as well as society is necessary.