Bioduro

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Release and Stability Testing

Tests necessary to verify drug product’s quality and documentation for entering clinical trials. IND-driven timeline management.

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Overview

BioDuro’s Quality Control group conducts in-process, release, and stability tests to support manufactured clinical trial materials. Bioduro’s quality control team collaborates closely with the manufacturing team and with Quality Assurance to ensure the timely delivery of IND-ready data, placing equal importance on releasing product as supporting ongoing stability studies. The Quality Control team is equipped with analytical capabilities and ICH compliant storage chambers to accurately capture all critical quality aspects of product from Phase 0-II.

The BioDuro Advantage

  • Strict adherence to ICH and cGMP guidelines
  • Continuity in analytical work – training and transfer of analytical methods to Quality Control
  • Effective communications in support of continuous project management model

Services

  • Assay/Impurities testing and method validation
  • Dissolution testing and method validation
  • Blend/Content Uniformity testing and method validation
  • Cleaning verification/validation
  • Protocol design
  • Long term stability testing
  • In-use stability testing
  • Accelerated stability testing
  • Forced degradation studies
  • Temperature cycling

Capabilities

  • Storage conditions
    • 25ºC/60%
    • 30ºC/65%
    • 40ºC/75%
    • 2-8ºC
    • -20ºC
  • Siemens APOGEE Monitoring System
  • Full generator backup
  • Drug product, drug substance, placebo
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