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)
Compliance program
Facility Monitoring System (FMS)
Compliance program
FDA, EMA, and ICH-aligned quality system
Compliance program
QMS
Quality certification
FDA
Quality certification
EMA
Quality certification
ICH
Quality certification