Antibody-Drug Conjugate (ADC) Characterization & Comparability
ADCs require expertise in both chemical and biological analytics for effective characterization and release testing. Solvias excels in integrating these two domains, ensuring comprehensive evaluations that address the complexities of ADC formulations. Our skilled team provides insights into both chemical composition and biological activity, supporting your development from initial phases through to commercial readiness.
Specific capabilities for ADC characterization include:
Primary Structure
- PepMap
- Amino acid analysis (including extinction coefficient)
- N-terminal sequencing
Higher Order Structure
- Circular dichroism (CD) for secondary structure
- Differential scanning calorimetry (DSC) for thermal stability
- Hydrogen-deuterium exchange (HDX)
Purity
- Size exclusion chromatography (SEC)
- Reversed-phase chromatography (RPC)
Functionality
- Cell based bioassay
- Enzyme-linked immunosorbent assay (ELISA)
- Surface plasmon resonance (SPR)
Heterogeneity & PTMs
- PepMap post-translational modifications (PTMs)
- Disulfide mapping
- Free thiol
- Carbohydrate structure (N-/O-Glycans)
- Conjugation confirmation (site specific)
Charges & Size Heterogeneity
- Ion exchange chromatography (IEX)
- Capillary isoelectric focusing (cIEF) and cIEF-MS
- Capillary zone electrophoresis (CZE)
- Size exclusion chromatography (SEC) or Size exclusion chromatography with multi-angle light scattering (SEC-MALS) or Asymmetrical flow field-flow fractionation with multi-angle light scattering (AF4-MALS)
- Intact mass (incl. Drug-to-antibody ratio)
- Capillary electrophoresis-sodium dodecyl sulfate (CE-SDS)
- Analytical ultracentrifugation (AUC)
