Founded in Frederick in 2004, BioFactura develops and manufactures biosimilars, biodefense medical countermeasures, and other biologic medicines using its patented StableFast biomanufacturing platform. The clinical-stage company has advanced programs for a smallpox therapeutic and a proposed ustekinumab biosimilar, while its Capitol Biologics division provides development and early-phase clinical manufacturing support to emerging biotech firms and government agencies.
Quality Management System (QMS)
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Facility Monitoring System (FMS)
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FDA, EMA, and ICH-aligned quality system
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