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Expect better

Contract manufacturing services

Curium is a fully integrated contract manufacturing organization, committed to delivering a better customer experience. Our capabilities enable us to deliver clinical and commercial drug product manufacturing to global radiopharmaceutical, biotechnology and pharmaceutical organizations.

Featuring our Barrier Isolator Technology, we focus on manufacturing higher quality products through reduced risk of human interaction, resulting in fewer opportunities for microbial contamination during processing.

By leveraging our extensive experience, knowledge and resources, we can confidently deliver a manufacturing service that is reliable, timely and cost-effective.

Curium is the largest vertically integrated radiopharmaceutical product manufacturer in the industry. Centrally located in St. Louis, MO, our manufacturing facility has an excellent regulatory and compliance track record with global regulatory agencies, including the FDA, Health Canada and MEA.

Drug Product Manufacture

  • State of the Art Barrier Isolator Technology
  • Vaporized Hydrogen Peroxide (VHP) and Autoclave Cycle Development Expertise
  • VHP Decontamination
  • Clinical & Commercial Scale
  • Vials & Syringes
  • 3mL-100mL (Vials)
  • 2.25mL (Syringes)
  • Aseptic Processing
  • Terminal Sterilization
  • Lyophilization
  • Labeling, inspection and packaging
  • Analytical Services
  • Microbiology Services
  • ICH Stability
  • Regulatory Services

Analytical and Microbial

  • Technical Transfer of Analytical and Microbiological Methods
  • Qualification of Analytical Methods
  • Validation of Methods
  • Sterility Testing
  • Stability Storage and Testing per ICH Guidelines
  • Incoming Raw Material and Finish Product Testing

Validation

  • Process Validation
  • Project Plan Assembly
  • Protocol Generation and Summary Reports
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)

For more information about Contract Manufacturing Services

Utilizing our extensive manufacturing network and state-of-the-art facilities, Curium can assist in the development and production of your pharmaceutical, biopharmaceutical and radiopharmaceutical product. Get in touch to discuss how our contract manufacturing services can help bring your product to market.