Full-Service Radiopharmaceutical CDMO

Take your scientific advancement to market with a full-service CDMO

Nucleus RadioPharma is an end-to-end contract development and manufacturing organization (CDMO) partner dedicated to building the robust clinical and commercial supply chains for targeted radiotherapies that make radiopharmaceutical companies—and the innovators driving advancements—successful.

Ensure reliable, and rapid manufacturing and delivery

No matter where you are on your targeted radiotherapy journey, you’ll receive optimal services that rapidly advance your program—we’re your dedicated partner every step of the way, ensuring patients receive your targeted therapy

2K Sq Ft

Dedicated R&D operations in MN

7.5K Sq Ft

Dedicated Manufacturing Space in MN

Flexible end-to-end CDMO services for radiopharmaceutical development and manufacturing.

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LABS

With 2,000 sq. feet of dedicated R&D space in our state-of-the-art facility in Rochester, MN, Nucleus RadioPharma has the capacity and ability to prioritize your radiotherapy or theranostic product development, regardless of the isotope.

Supply Chain

With an isotope-flexible approach and specialized radiopharmaceutical logistics expertise, Nucleus RadioPharma supports secure, reliable supply chain solutions across development and manufacturing programs.

Manufacturing

With one fully operational space in Rochester, MN, and two expansion sites under construction, Nucleus RadioPharma has the capacity and specialized infrastructure to meet any radiopharmaceutical manufacturing need—from clinical trials through commercial production.

Quality & Regulatory

With manufacturing facilities designed to support compliance with 21 CFR Part 211, Nucleus RadioPharma’s quality systems and regulatory approach are built to meet radiopharmaceutical safety, compliance, and operational requirements.

Quality Assurance and Regulatory Compliance:

Our facilities and quality systems are designed to support compliance with applicable radiopharmaceutical regulatory, safety, and operational requirements across development and manufacturing activities.

cGMP environment

Facilities designed to support operations in alignment with 21 CFR 211, with planned expansion sites intended to align with EU Annex 1 and ISO 13408-6 expectations.

Radiation Safety

Manufacturing and R&D facilities independently licensed for radioactive materials and transportation approvals for shipping hazardous materials. State of the Art Carbon Filtration System Compliant to USNRC Regulatory Guide 1.52 for residence time and volumetric airflow

Electronic QMS

Corporate electronic Quality Management System established and aligned with 21 CFR Part 211 and ICH Q10 supporting controlled documentation, change management, deviations, and CAPA.

Dedicated R&D space segregated from GMP manufacturing areas

Every detail of our state-of-the-art, commercial-scale facilities is built with one purpose in mind: Advancing the development, manufacturing, and delivery of our clients’ radiotherapies quickly, efficiently, and safely.

Rochester, MN

Second-floor R&D labs are separated from first-floor GMP manufacturing, enabling parallel work, collaboration, and full GMP compliance.

Springhouse Innovation Park, Lower Gwynedd, PA

Situated on a large life sciences campus, with over 47K sq ft of manufacturing space just north of Philadelphia, and conveniently located within an 8-hour driving radius of key markets

Second-floor R&D labs are separated from first-floor GMP manufacturing, enabling parallel work, collaboration, and full GMP compliance.

Situated on a large life sciences campus, with over 47K sq ft of manufacturing space just north of Philadelphia, and conveniently located within an 8-hour driving radius of key markets