CDMO/CMO

Radiopharmaceutical
CDMO/CMO

NorthStar Medical Radioisotopes is a leader in novel, domestic and environmentally preferred radioisotope development and production. Technologies that advance the availability of radiopharmaceuticals are increasingly critical for the treatment of cancer. NorthStar’s patient-focused Radiopharmaceutical Contract Development and Manufacturing Organization (CDMO/CMO) addresses this important need.

FROM DEVELOPMENT TO COMMERCIALIZATION

Our comprehensive services support collaborator companies by providing customized solutions to help navigate the complex radiopharmaceutical development and manufacturing process. NorthStar’s Radiopharmaceutical CDMO/CMO services span the spectrum of radioisotope drug development, from research and scale-up through commercialization, and all are designed to meet rigorous clinical trial and patient use requirements. Our proven expertise in innovation, engineering, manufacturing, quality assurance and quality control, adherence to regulatory standards, and logistics are applied to meet each customer’s specific needs.

R&D contract manufacturing services are currently available.

Services

  • Programs designed for radiopharmaceuticals and radioactive medical devices
  • Radionuclide supply: internal production or external procurement
  • Alpha, beta and gamma flexibility and capabilities
  • Test methods, formulation, process development & optimization
  • Batch scale-up and process automation
  • Technology transfer and integration efficiencies
  • Stability assessment and stability program management
  • Packaging and labeling development (vials and syringes)
  • Fully dedicated logistics team 24/7
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OUR CDMO/CMO FACT SHEET

Facilities and
Equipment

  • 55-acre campus designed with a purpose
  • 52,000 sq ft, fully-equipped radiopharmaceutical CDMO/CMO facility with immediate expansion opportunities
  • Full service analytical and microbiological laboratories
  • Redundancy of equipment, capabilities, personnel, and power
  • R&D, preclinical, and early phase development suites
  • Phase I, II and III clinical trial manufacturing
  • Flexible cGMP suites fully-equipped for alpha/beta/gamma
  • Clinical unit dose preparation (vials and syringes)
  • Type A packaging and DOT-certified shipping with cold chain capabilities
  • Dedicated office space on site for sponsor access
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Quality Assurance

  • cGMP-compliant (Title 21 CFR Parts 210/211) Quality Management System (QMS)
  • Periodic internal audits and sponsor qualifications
  • Integrated quality event and complaint handling procedures, including investigation, tracking, trending, and reporting
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Regulatory Affairs

  • Regulatory and administrative services to support Investigational New Drug Application (IND), New Drug Application (NDA) and Drug Master File (DMF)
  • Ability to author, publish and submit sections of the Common Technical Document (CTD)
  • EU-dedicated CMO suite (EudraLex Vol. 4)
MEET THE TALENTED PEOPLE WHO LEAD NORTHSTAR

TIMELINE

Oct 2022
Facility Groundbreaking
Early 2023
Construction begins
July 2024
Construction complete
Jan 2025
CDMO/CMO Production Operations Launch

NorthStar will be the first and only U.S. company housing commercial-scale, multi-radioisotope production radiopharmaceutical development services on the same campus. This enables collaborator companies to realize logistical, regulatory and cost benefits.

PARTNERING WITH
NORTHSTAR

For more information, please contact [email protected], and visit us here to learn about the continued progress of NorthStar’s Radiopharmaceutical CDMO/CMO.