Method Development & Validation
We design and validate analytical methods tailored to your molecule
Our validation follows ICH Q2(R2) guidelines and covers chemical, structural, and physical assays.
Benefit
- Tailored methods for complex proteins and peptides
- Integration of chemical, structural, and thermal assays
- Reproducible workflows that transfer seamlessly to QC and regulatory settings
Techniques & Methods
HPLC/LC-MS workflows
RP-HPLC, SE-HPLC, IEX, intact mass, peptide mapping
DSC
Thermal stability and unfolding profiles
Circular Dichroism (CD)
Secondary structure integrity
Dynamic Light Scattering (DLS)
Particle size and aggregation
Validation parameters
Accuracy, precision, linearity, specificity, robustness, LOD/LOQ