Center for Translational Science and Biopharmaceutical Development

Abstract

Technological advances are continually emerging 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 Poisonous Animals (CEVAP) - Translational Research Unit at UNESP - has been prospecting and developing candidate molecules for the production of biopharmaceuticals since its foundation. Two bioproducts named respectively "Fibrin Sealant" and "Antiapeptic Serum" were developed by our team and have already crossed the "Valley of Death", and are awaiting investments for phase III clinical research and subsequent registration with ANVISA for distribution in the System's network Health Service (SUS). To meet the last stage of phase III research, the product needs Good Manufacturing Practices. To overcome this challenge, the researchers submitted to the Ministry of Health the construction of the Pilot Batch Factory for Biopharmaceuticals for Clinical Research, the only one in Latin America, which was approved and tendered by UNESP in August 2021 at 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 continuing existing products, will develop and implement platforms for prototyping recombinant molecules for a new fibrin 2.0 sealant to improve its performance as a wound healing agent; to research and produce mono and polyclonal antibodies against Sars-Cov-2, and finally to implement a platform for serological diagnosis against COVID-19 based on recombinant antigens. Antibody production and serological diagnosis technologies can be transferred to meet other viral diseases given the versatility and applicability of the proposal. In order to make the project viable, the applicants based at UNESP (Headquarter Unit), USP and Biological Institutes, Adolfo Lutz and Emilio Ribas (Partner Institutions), in addition to collaborating foreign institutions will put their greatest efforts to achieve the established goals and implement the projects and proposed subprojects. We will also have the participation of visiting researchers from KU Leuven from Belgium, and SRM University Delhi-NCR from India. The economic and financial counterparts are respectively R$ 10,280,728.92 and R$ 25,808,341.92, in addition to the UNESP commitment to hire 3 researchers and 3 technicians in the amount of R$ 4,056,378.75 for the project period. FAPESP will be responsible for the total amount of R$ 9,780,662.81, including for equipment only R$ 89,052.00 (domestic) and U$ 89,277.14 (imported) - already included in the total value of the project. (AU)