ANIMAL FACILITY AND BIOSAFETY - INCREASE IN BIOSAFETY LEVEL 2 (BSL-2) TO BIOSAFETY LEVEL 3 (BSL-3) - MOLECULAR VIROLOGY LABORATORY AND CELLULAR AND MOLECULAR BIOLOGY OF MICROORGANISMS.

• Grant number: 25/07072-4
• Support Opportunities: Research Infrastructure Program - Improvement of the Operational Infrastructure of Small-Animal Facilities and Biosafety
• Start date: November 01, 2025
• End date: October 31, 2028
• Field of knowledge: Biological Sciences - Microbiology - Applied Microbiology
• Principal Investigator: Paulo Ricardo da Silva Sanches
• Grantee: Paulo Ricardo da Silva Sanches
• Host Institution: Faculdade de Ciências Farmacêuticas (FCFAR). Universidade Estadual Paulista (UNESP). Campus de Araraquara. Araraquara , SP, Brazil
• City of the host institution: Araraquara
• Associated researchers: Leonardo Miziara Barboza Ferreira ; Marlus Chorilli ; Norival Alves Santos Filho ; Paulo Roberto Bueno ; Sidney José Lima Ribeiro ; Valéria de Carvalho Santos Ebinuma ; Vanderlan da Silva Bolzani

Abstract

The proposal to elevate the biosafety level of the laboratory from BSL2 to BSL3 aims to expand research capacity, enabling the study of high-risk viruses such as SARS-CoV-2, Mpox, and H5N1, as well as facilitating preclinical trials and the development of antiviral therapies and vaccines. The expansion will also allow the use of advanced high-throughput screening technologies for new compounds, formulations, and the evaluation of new vaccines, while strengthening the training of qualified human resources in virology and biosafety. This elevation will have significant impacts on both knowledge advancement and scientific competitiveness, both nationally and internationally, and will expand inter-institutional partnerships. The laboratory will be focused on research and development of innovative and technological therapeutic solutions, with the potential to influence responses to epidemics and pandemics.The Molecular Virology Laboratory and Cellular and Molecular Microorganism Biology Laboratory was established in 2022, with the hiring of Prof. Dr. Paulo Sanches as a faculty member at the School of Pharmaceutical Sciences at UNESP in Araraquara. Despite its recent establishment, the laboratory already stands out for its research and multi-user character, with a considerable range of equipment for virus research, student and collaborator training, as well as securing financial resources for the maintenance of research and laboratory infrastructure. With the modernization of the laboratory infrastructure, aligned with the regulations and requirements established by national biosafety laws, it will be possible to apply to the National Biosafety Committee (CTNBio) for certification as a Biosafety Level III (NB-III) laboratory. Compliance with these requirements will ensure that the laboratory is in accordance with Law No. 11.105/2005 (Biosafety Law) and with the standards established by ANVISA and CTNBio, which regulate the handling of genetically modified organisms (GMO) and high-risk pathogens. This certification will allow the laboratory to be officially recognized as a unit qualified to conduct research with high-risk biological agents.With the modern infrastructure certified by CTNBio, the laboratory will be able to respond more swiftly and safely to potential outbreaks or health crises, conducting essential research for the development of vaccines, therapies, and prevention strategies, while ensuring that all handling and experimental practices are aligned with the best internationally recognized biosafety standards. This certification process will also strengthen the laboratory's position in collaborative networks both in Brazil and internationally, enabling greater scientific competitiveness and attracting partnerships and resources for cutting-edge research. Therefore, the approval of this project represents a strategic investment for the advancement of molecular virology in the interior of the State of São Paulo, in a strategic city, with a direct impact on public health, technological innovation, diagnostics, and the development of new antiviral compounds and vaccines. (AU)