Manufacturing And Blinding



API Precision Dispensing

API Precision dispensing designed to accelerate supply to clinic

Built on a solid foundation of over 400+ clinical batches manufactured and 100+ API’s evaluated, our precision dispense technologies provide the speed, flexibility and efficiency to help accelerate your material to the clinic.

Our systems reduce your timelines by eliminating excipient compatibility, simplifying analytical methods, and eliminating content uniformity testing.  In addition, they provide documentation of every capsule weight and can reduce formulation costs by eliminating complex analytical methods.

With two systems to choose from, we can create a solution to meet your needs.  Xcelodose® enables robust, reproducible and precise filling of drug substance directly into capsules, while our AutoDose’s Powdernium® offers additional flexibility by dispensing drug substance directly into capsules, vials, or bottles.

Catalent Benefits
  • Xceledose™ API Precision Dispensing
    • Faster drug development
    • Less waste
    • Removes excipient requirement and simplifies drug product stability
    • No formulation development for early studies
    • Highly consistent dose accuracy
    • Automatically optimized filling process
    • Accerlerated NCE kill rate and formulation development timeline
  • AutoDose Powdernium™
    • Accelerates timelines and NCE evaluation for first-in-man studies
    • Minimizes drug substance for first-in-man studies
    • Consistent and reliable weighing results
    • Minimizes formulation development and cost
    • Provides for additional dose strengths with minimal additional cost
    • Minimizes analytical costs
    • Reduces stability timelines and cost
    • May eliminate need to develop and transfer analytical cleaning methods
Catalent Capabilities
  • Xceledose API Precision Dispensing
    • 300-600 Capsules/hr
    • 1,000 – 30,000 batch size range
    • 0.1mg-250mg Fill range (depending on API density and capsule size) 
  • Autodose Powdernium 
    • 40-60 Capsules/hr
    • 1,000 – 10,000 batch size range
    • 2mg-250mg Fill range (depending on API density and capsule size)
Facilities

With clinical storage and distribution networks around the world - including over 50 audited depots - our capacity enables us to adapt to and handle all your international compliance and logistics needs, ultimately reducing your turnaround time.

  • Kansas City, Missouri, USA

XCELODOSE is a registered trademark of Capsugel Belgium BVBA
POWDERNIUM is a registered trademark of Freeslate, Inc.