Positioning Mason's Regional Biocontainment Laboratory for Effective Pandemic Preparedness

OVERALL CORE ABSTRACT George Mason University (GMU) Biomedical Laboratory (BRL) is one of 12 Regional Biocontainment Laboratories (RBLs) established through NIAID support in the early 2000s to serve as Biosafety Level 3 (BSL-3) facilities to conduct cutting edge pathogen research and serve as resources to rapidly address emerging infectious disease outbreaks. The BRL serves

as a center for scientific collaboration to 1) generate advanced knowledge of pathogen biology and host interaction mechanisms, and 2) evaluate diagnostics, therapeutics and vaccines. The Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) pandemic exposed critical vulnerabilities to the nation’s BSL-3 research infrastructure, including the GMU BRL facility.

GMU learned that there are gaps and opportunities to enhance safe BRL operations management to more effectively face sudden disease outbreaks and support a more robust pipeline of innovations for response to future pandemics. This proposal outlines activities for three cores to enhance the BRL facility, increase high containment training, and provide

additional BSL-3 research services for pre-clinical innovation. The GMU RBL will 1) Implement a comprehensive BSL-3 facilities preventative maintenance and upgrade plan to ensure continuity of operations, compliance with federal regulations, and a safe and secure facility; 2) Enhance safety and quality of BSL-3 laboratory practices; and 3) Create two new research cores in high

containment. The expanded Microphysiological Systems (MPS) core will enable organ-on-a- chip (OOC) and organoid models for lead optimization, safety assessment, off target effects, toxicity, and efficacy analysis. The Advanced Animal Research (AAR) core will support pre- clinical studies starting with in vivo exposures and countermeasure testing and transitioning to

advanced animal imaging, spatial tissue, and cellular analysis. Together, the cores will accelerate vaccine and therapeutic drug discovery and improve understanding of the transmission and pathogenesis of infectious agents as well as host response.