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Biotech CDMO Services

Accelerate your path to market with end-to-end CDMO services

Our end-to-end CDMO services bridge the gap between scientific potential and real-world application, ensuring that innovators at biotech organizations can bring their life-saving radiotherapies to market and patients receive timely, cutting-edge care.

With Nucleus RadioPharma as your dedicated partner, you can:

  • Reduce ambiguity risk in product development
  • Leverage our national manufacturing footprint
  • Meet the unique delivery demands of radioactive isotope-based products
  • Accelerate your path to commercialization
  • Transform cancer care
Discover how we can help you

A flexible approach to development and production

Our flexible approach allows us to adapt to diverse client needs across the entire spectrum of drug development and manufacturing.

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.

development and formulation icon
Development and formulation:
  • Establishing radiolabeling procedures
  • Attach radioisotopes to antibodies, peptides, and other small molecules
  • Creating and validating analytical methods
  • Ensuring processes and analytical methods meet regulatory requirements
  • Evaluating drug stability in different conditions
  • Defining product shelf-life and storage needs
QA and regulatory compliance
Quality assurance and regulatory compliance:
  • Adherence to laboratory best practices and regulations
  • Quality control throughout development
  • Guidance through regulatory processes
  • Assistance in drafting CMC regulatory submissions (e.g., IND)
Scale-up and management icon
Scale-up and management:
  • Scaling up from lab to pilot production
  • Managing technology transfers
  • Securing consistent raw material supplies, including radioisotopes
Clinical trial manufacturing icon
Clinical trial manufacturing:
  • Administrative setup and project design for manufacturing for clinical trials
  • Establish protocols for and execution of process validation
  • Scaling up processes and confirming methodology
  • Perform tests to ensure product stability
  • Compile comprehensive reports for regulatory submission
  • Secure consistent raw material supplies, including radioisotopes
  • Management of technology transfer in different clinical and commercial phases

Ensure reliable, and rapid manufacturing and delivery

There may only be days, or sometimes even hours, to manufacture, release, ship, and administer a dose to a patient.

Without the proper planning or resources, you may not be able to reach patients in time and, ultimately, waste doses.

With these unique demands in mind, we’re building our development and manufacturing facilities in proximity to prominent destination medical centers and key distribution hubs.

Our growing national manufacturing footprint and interconnected resource network allow your organization to reliably and rapidly produce and deliver radiotherapies.

commercial-scale radiopharmaceutical CDMO facility

Production is scheduled to begin in Q4 2024 at our newly opened Rochester, MN facility.


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