Product characterization

• In-depth drug substance & product characterization with a broad suite of analytical techniques, including but not limited to
  • High resolution mass spectrometry (LC-HRMS)
  • Chromatography (HPLC/UPLC)
  • Spectroscopy
  • (Capillary) gel electrophoresis
• High-quality, reproducible data to support CMC strategy and regulatory submission.
• Expert scientific interpretation to de-risk development decisions and accelerate program timelines.

Meet our scientists

 

Our end-to-end analytical solutions for drug development

• Analytical Method and Lifecycle support

  • Assay & Method development
  • Method qualification
  • Method validation
  • Method transfer
  • Method lifecycle management
  • CMC consultancy
• Stability studies

  • ICH conditions
  • In-use stability
  • Forced degradation studies
  • Predictive stability studies
• Characterization studies

  • Developability
  • Product characterization
  • Process characterization/control
• Release testing

  • Non-GMP/GMP batches
  • Tox, PPQ and validation batches
  • Clinical and commercial batches