Design, establishment and accreditation of biosafety Level 3 laboratory using the Egyptian experience for sustainable high-containment capacity in national biological defence structure

BSL-3 laboratories are crucial for global health security because they provide a basis for the research and diagnostics of new and known infectious agents. Yet few such facilities have been established, and those that do exist struggle to remain due to technical, regulatory and financial limitations, particularly in low- and middle-income areas. This review combines cross-sectoral evidence from international management and laboratory competence standards, engineering and design work, and recent mapping exercises of global BSL-3 infrastructures from 2000 to 2025. Using this methodology, we established a four-phase lifecycle model (pre-construction, construction, post-construction, and accreditation and sustainability) for assessing operational resilience, biosafety culture and determinants of regulatory compliance. Worldwide, more than 3,500 BSL-3 facilities exist in 149 countries, while BSL-4 laboratories are restricted to fewer than 80 (Muluneh et al., 2025; WHO, 2024). Since the COVID-19 pandemic of 2020, growth has accelerated, indicative of a greater national commitment to building capacity for diagnostic testing and epidemic preparedness. Nonetheless, there are major disparities; 82 percent of high-containment capacity is only in high-income areas. Some of the sustainability challenges are a lack of continuous funding (i.e. the ‘funding cliff’), regulatory harmonisation gaps and a shortage of trained biosafety personnel. However, innovations in engineering (N + 1 HVAC redundancy, dual HEPA filtration or integrated QMS frameworks) have been critical for enabling the ongoing performance and long-term safety of containment. Developing reliable biosafety governance and workforce sustainability in BSL-3 labs requires a systems engineering approach. A cooperative global investment approach is merited to increase high-containment capacity, for example developing standardised accreditation frameworks and continuous professional development to secure safety and scientific equality.