Assay & Method development

• Delivering a comprehensive set of custom-made, orthogonal methods for
  • identity
  • quantity/content/assay
  • potency
  • product purity & product-related species
  • impurities (product-related, process-related & host cell derived)
• Providing robust tools with the specificity, sensitivity, accuracy & precision required for you to track critical quality attributes (CQAs).

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