Developability

• Comprehensive developability assessments to evaluate the biophysical characteristics, stability, and manufacturability of lead therapeutic candidates.
• De-risk development pipelines by identifying potential issues—such as aggregation, poor solubility, or instability—early in the process, allowing for the selection of the best lead for scale-up and clinical production.
• Key analytical technologies for developability assessment include:
  • Purity/aggregation: e.g. SEC, CE-SDS
  • Thermal stability: e.g. DSC
  • Post-translation modification: e.g. LC-HRMS
  • Solubility
  • Specificity: e.g. ELISA

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