Company intelligence
Soter Bio
U.S.-based CDMO for advanced RNA, biomolecules & GMP API manufacturing under domestic regulatory oversight
About Soter Bio
Founded in Q4 of 2025 and headquartered in Houston, Texas, Soter Bio is a U.S.-based Contract Development and Manufacturing Organization (CDMO) dedicated to restoring and strengthening domestic manufacturing of advanced biomolecules and active pharmaceutical ingredients (APIs) under U.S. regulatory oversight. Soter Bio provides end-to-end development and regulated manufacturing infrastructure — from starting materials through finished drug product — supporting both Research Use Only (RUO) and Good Manufacturing Practice (GMP) programs. We are establishing a dedicated, U.S.-based platform for advanced RNA manufacturing, integrating: Closed, automated production systems Scalable domestic infrastructure Secure, compliant manufacturing environments This platform is designed to repatriate critical biomanufacturing capabilities, strengthen supply-chain security, and deliver reliable, scalable capacity aligned with industry needs, public health priorities, and national preparedness objectives. Our Mission To strengthen U.S. biomanufacturing resilience by delivering secure, scalable domestic manufacturing infrastructure aligned with federal preparedness priorities and Biosecure policy objectives. Soter Bio partners with pharmaceutical and biotechnology companies, foundations, and public-sector stakeholders to support: Innovation in advanced therapeutics Continuity of supply National readiness and response capabilities For more information about Soter Bio, please visit https://soter-bio.com/
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