Basic Info
  • Factory Location: suzhou

    Main Sales Markets: North America,Central/South America,Western Europe,Eastern Europe,Asia,Middle East,Africa

  • Sample Provided: no

    Payment Terms: L/L

    Powder Micro-Dosing Equipment

    Micro-dosing is the process of dispensing a precise amount of drug substance into a capsule (or other container, e.g. vial or bottle), for use in early phase human studies (phase I safety evaluations). 

    PREFORMULATION & PRECLINICAL SERVICES

    Drug substance “powder-in-capsule” (PIC) studies generally avoid the use of excipients – and the compatibility and stability studies associated with their use – for these initial evaluations thereby accelerating early phase product development timelines. Accelerating these initial studies to determine if the drug substance should receive further investment is critical in cost-effective product development.

    A summary of PIC program benefits using Xcelodose® Micro-dosing Systems follows: 

    • Streamlines product development 
    • Minimizes drug substance usage in formulation development 
    • Eliminates excipient compatibility screening 
    • Simplifies analytical and stability evaluations 
    • Increases efficiencies via programmable and precise dispensing of drug substance into capsules 
    • Provides supporting documentation including weights for each capsule produced 
    • Cost-effective 
    • Reduces waste of material 
    • Minimizes analytical and formulation development costs 
    • Allows for multiple strengths to be prepared for the clinic using the same process 

    Centers of Excellence 

    Lonza offers PIC services using Xcelodose® Systems in support of early phase clinical programs around the world. Our Center-of-Excellence for PIC studies is based in Tampa, FL which includes micro-dosing, primary and secondary packaging, kitting, global distribution and return services. The Tampa site offers integrated product development and manufacturing, and multiple Xcelodose® units to support both pre-clinical assessments and clinical PIC manufacture. 

    A full range of preformulation, analytical and formulation development services support phase I-IV studies and commercialization. Best practices have been developed for process transfers from Xcelodose® systems to larger-scale clinical and/or commercial scale batches utilizing Harro Modu-C units.

    We offer a range of Micro-dosing Systems to meet your needs:

    • Xcelolab® for lab-scale 
    • Xcelodose® 120S: semi-automated 
    • Xcelodose® 600S: fully automated 
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