Compare CDMOs with BSL-3 containment facilities for manufacturing involving high-risk pathogens, pandemic preparedness, and select agent programs.
BSL-3 facilities handle agents that can cause serious or potentially lethal disease through inhalation. In pharmaceutical manufacturing, BSL-3 is required for: work with select agents (CDC/USDA regulated), certain live pathogen vaccine manufacturing steps, challenge agent preparation, and manufacturing involving respiratory pathogens before inactivation. BSL-3 CDMOs represent a small, specialized subset of contract manufacturers.
BSL-3 facility requirements are extensive: double-door entry with air locks, negative pressure throughout, HEPA-filtered exhaust, sealed penetrations, gas-tight dampers, decontamination of all waste before removal, personnel shower upon exit, respiratory protection programs, and regular emergency drills. CDC/APHIS registration is required for facilities handling select agents. The capital cost and operational overhead of BSL-3 manufacturing is 3-5x that of standard GMP manufacturing.
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