LABS

Accelerate radiopharmaceutical development and research in a controlled environment

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.

Innovate with confidence

We support radiopharmaceutical innovation from early-stage development through technology transfer. Our custom-designed R&D space offers innovators the opportunity to refine, test, and advance product development without the risk of cross-contamination. With the capacity to work with any and all isotopes—regardless of their complexity—our expert team can consult on target material optimization, manage seamless radiopharmaceutical technology transfers, and more.

Outcome

– Radio-labeling procedures.
– Chelation of radioisotopes to antibodies, peptides, mini-proteins, and small molecules.
– Specifications development.
– Ensure processes and analytical methods meet regulatory requirements.
– Radiopharmaceutical technology transfer.

Outcome

– 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.

Outcome

– Evaluation of customer-provided procedures.
– Adapt procedures to Nucleus equipment.
– Develop transfer/verification/validation protocols.
– Ensure processes and analytical methods meet regulatory requirements.

Why choose Nucleus Radiopharma for your R&D needs?

Isotope-flexible approach tailored to your therapeutic and diagnostic needs Seamless R&D-to-manufacturing transition with space dedicated to early-stage formulation and process refinement Regulatory-ready development with built-in quality and safety exceeding industry standards

2K Sq Ft

R&D Lab located on 2nd floor separated from 1st floor production

Isotope Flexible

Fully Licensed for all radioactive work

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

R&D FAQs

Exhaustive permission for working with all theranostic isotopes

Non-exhaustive list of radioisotopes our team has experience with:

Actinium-225
Astatine-211
Bismuth-213
Copper-61
Copper-64
Copper-67
Flourine-18
Gallium-68
Indium-111
Iodine-123
Iodine-125
Iodine-131
Lead-203
Lutetium-177
Radium-224
Rhenium-186
Rhenium-188
Samarium-153
Technetium-99m
Terbium-149
Terbium-152
Terbium-155
Terbium-161
Thorium-228
Lead-212
Thorium-227
Tin-117m
Yttrium-90
Zirconium-89

Our approach remains flexible, allowing us to adapt to diverse client needs. Whether you’re in discovery mode or nearing IND, we are ready to partner with you.