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Drug Development at BioDuro

Analytical

Full analytical services enabling an integrated and efficient development path. Method development and in-process testing activities guided by industry experts.

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Overview

From discovery candidates to clinical trial materials, BioDuro’s analytical team provides the necessary data needed throughout the development process.  BioDuro’s cGMP analytical laboratories facilitate integrated and efficient project support with analytical scientist actively engaging with clients and providing analyses to Formulations and Manufacturing departments. Equipped with state-of-the-art instruments, BioDuro’s experienced analytical team ensures quality services through Phase III studies.

The BioDuro Advantage

  • Strict adherence to ICH and cGMP guidelines
  • Continuity in analytical work – training and transfer of analytical methods to Quality Control
  • Engagement in project management throughout the development process
  • Development of robust and easily transferrable methods

Services

Our analytical team provides a broad range of services including:

Capabilities

Our laboratories host state-of-the-art instruments enabling the following:

  • Chromatography
  • Spectroscopy
  • Dissolution and Disintegration Testing
  • Karl Fischer
  • Physical Testing
  • Particle Analysis
  • Thermal Analysis
  • Microscopy

Equipment

Liquid Chromatography:

  • Dionex Corona Charged Aerosol Detector
  • Waters UV/Vis, PDA Detector
  • Waters, Agilent HPLC
  • Waters UPLC

Gas Chromatography:

  • Agilent G6890, G1888 Headspace Sampler

Spectometry:

  • Agilent Cary 60 UV-Vis Spectrophotometer
  • Perkin-Elmer Spectrum 100 FTIR
  • Molecular Devices Spectramax

Particle Sizing:

  • Malvern Mastersizer 2000

Thermal Analysis:

  • TA Instruments Modulated DSC w/Autosampler
  • Perkin-Elmer Pyris Thermogravimetric Analyzer

Dissolution and Disintegration:

  • Agilent Dissolution Test Station w/Autosampler
  • Hanson Research QC-21 Disintegration Test Systems
  • Vankel Enhancer Cell
  • Hanson Research Ointment Disk

Other:

  • Mettler Toledo DL38 Karl Fischer Titrator
  • Leica Polarizing Light Microscope
  • Varian/Venkel Hardness Tester
  • Erweka Friability Tester
  • Thermo Scientific Savant High Speed Solvent Evaporator
  • Rigaku X-Ray Powder Diffraction Analyzer
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