Quantoom Biosciences Appoints Soter Bio As Exclusive North America RNA CDMO For RUO And GMP Manufacturing

Quantoom Biosciences, a leader in integrated RNA-LNP manufacturing technologies, today announced Soter Bio as its exclusive RNA Contract Development and Manufacturing Organization (CDMO) for both Research Use Only (RUO) and GMP manufacturing across North America, including the United States, Canada, and Mexico. This designation establishes a dedicated U.S.-based platform for end-to-end RNA manufacturing, from DNA through RNA drug product and fill/finish, supporting programs from early research through clinical and commercial supply using Quantoom’s closed, automated GMP manufacturing systems.

Under the strategic alliance, Soter Bio will exclusively deploy Quantoom’s N-Force platform and its components (Ncode, Ntensify, and Ncapsulate) to deliver fast, scalable, regulatory-ready RUO and GMP RNA-LNP manufacturing capabilities. Through this collaboration, a rapid transition toward RNA-based therapeutics will be possible for pharmaceutical and biotechnology companies, foundations and nonprofit therapeutic developers, as well as government, public health and biodefense programs.

The fully integrated, turnkey platform is designed to support seamless transition from discovery to clinical and commercial production. This will strengthen regional manufacturing resilience and supply chain security as well as enable distributed and decentralized manufacturing models, including vaccine and medical countermeasure deployment when required.

“The United States requires resilient, domestic RNA manufacturing infrastructure capable of responding at speed and scale,” said Mike Stewart, Founder and CEO of Soter Bio. “This alliance enables the launch of Soter Bio with a proven, industrialized RNA platform from day one, designed to support next-generation therapeutics as well as public health and biodefense programs. By integrating a closed, automated, end-to-end GMP RNA manufacturing system within U.S.-based operations, we are addressing long-standing challenges related to scalability, cost, and operational readiness—serving not only large pharmaceutical and biotechnology developers, but also foundations and innovators advancing rare and unmet medical needs, while maintaining flexibility to support distributed response strategies when public health demands it.”

“Quantoom Biosciences’ mission is to accelerate the future of medicine by empowering rapid development of RNA-based therapeutics through the N-Force platform—strengthening global pandemic preparedness against hazardous pathogens, unlocking personalized treatments such as cancer and cell & gene therapies, and enabling scalable production of veterinary vaccines worldwide,” said José Castillo, CEO of Quantoom Biosciences. “Designating Soter Bio as our exclusive RNA CDMO for North America ensures our N-Force platform is deployed through a dedicated partner capable of supporting RUO and GMP programs across pharma, biotech, and public-sector applications. This partnership establishes a strong foundation for expanding RNA manufacturing capacity while maintaining the rigor required for advanced therapeutic development.”

About Soter Bio
Soter Bio is a U.S.-based contract development and manufacturing organization (CDMO) dedicated to restoring critical advanced biomolecule and active pharmaceutical ingredient (API) manufacturing capabilities to the United States. Headquartered in Houston, Texas, the company is developing a secure, GMP-compliant domestic platform for advanced RNA manufacturing, leveraging closed and automated production systems within regulated U.S. infrastructure.

Soter Bio’s mission is to strengthen U.S. biomanufacturing resilience by enabling rapid, scalable, secure domestic manufacturing aligned with federal preparedness priorities, public health needs, and national biosecurity objectives. The company partners with pharmaceutical and biotechnology leaders, foundations, and public-sector stakeholders to ensure continuity of supply, support innovation, and enhance national readiness.

For more information, visit https://soter-bio.com/