Manufacturing

Manage the complexity of radiopharmaceutical manufacturing and production with confidence

With one operational location 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.

State-of-the-Art custom designed formulation, dispensing, inspection, labeling, and packaging hot cells

High-quality equipment increases production, performance, and quality, while reducing potential batch failures

De-risk radiopharmaceutical manufacturing scale-up

Compared to traditional pharmaceuticals, radiotherapies often have compressed approval timelines. As a result, pharmaceutical and small biotech companies must build manufacturing capacity and take on scale-up risks far sooner than is typical. With small-scale and fully automated production lines, our proactive facility design anticipates the evolution of radiotherapies and ensures adaptability to meet your radiopharmaceutical manufacturing needs.

Outcome

– Integrated technology transfer process for seamless scale-up.
– Regulatory-ready processes that include validated protocols, stability studies, and report submissions support.

Outcome

– Support formulation and analytical development for improved stability.
– Drug stability testing under real-world storage and transportation conditions.
– Shelf-life validation to meet regulatory and clinical requirements.
– Built-in redundancy and backup to ensure an uninterrupted supply.

Spring House, PA

– 47,000 square feet of dedicated manufacturing space.
– Up to 450K product vials/year.
– Fully automated production with 16 Hot Cells/4 Production Lines, with room for expansion to meet market demand.

Quality Assurance and Regulatory Compliance

All our facilities are built to exceed compliance and our proactive design will help you meet radiopharmaceutical regulatory, safety, and operational requirements today and into the future.

cGMP environment

Facilities built for operating under 21 CFR Part 211 with PA/AZ expansion sites also aligned to EU Annex 1. ISO 13408-6 Aseptic processing of health care products

Radiation safety program

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 Quality Management System established and aligned to 21 CFR Part 211 and ICH Q10

Manufacturing FAQs

Radiopharmaceutical Manufacturing Challenges

Current capacity in Rochester is ~10,000 product vials a year.

Starting capacity at our Rochester, MN location is 10K product vials/year with the ability to scale manufacturing over time to ~40-50K product vials/year.

With our expansion locations in PA, our production will increase to ~450K product vials/year.

Our facilities are designed for shared or dedicated product lines to minimize development and scale-up disruptions for our customers.

No, we're not here to compete: we're here to collaborate. We are solely focused on your projects and needs.

Why choose Nucleus RadioPharma for your manufacturing needs?

Industry-leading manufacturing capacity: scale your radiopharmaceutical production with the largest dedicated manufacturing footprint, ensuring uninterrupted supply and room for growth. Strategically located facilities: reduce transit times and improve supply chain efficiency with regional manufacturing sites near key population centers. CDMO-only focus: get priority access to capacity and expertise with a CDMO partner that doesn’t compete with you.