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.
Manufacturing
Manage the complexity of radiopharmaceutical manufacturing and production with confidence
- Current production capacity:
Up to 10,000 product vials/year - Full-scale capacity:
Up to 110,000 product vials/year at MN location - Expanding to:
1.2M product vials/year at full capacity in PA & AZ locations
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.
For clinical trial manufacturing:
- Comprehensive project design and administrative setup
- Proven technology transfer process for seamless scale-up
- Regulatory-ready processes that include validated protocols, stability studies, and report submissions support
For commercialization:
- Lead 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 uninterrupted supply
Expansion sites coming soon
Spring House, Pennsylvania
- 47,000 square feet of dedicated manufacturing space
- Up to 600,000 product vials/year
- 2 small-scale lines with 2 isolators to start
- Multiple fully-automated lines
Mesa, Arizona
- 52,800 square feet of dedicated manufacturing space
- Up to 600,000 product vials/year
- 2 small-scale lines with 2 isolators to start
- Multiple fully-automated lines
Why Nucleus Radiopharma for your radiopharmaceutical 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.
