Strengthening cIEF Method Validation With cIEF-MS

A biopharma company preparing for method validation needed to identify the charge variants detected in its capillary isoelectric focusing (cIEF) assay. While the method provided excellent separation, it could not determine the molecular identity of each peak, creating uncertainty around method robustness and regulatory readiness.

Solvias combined cIEF with high-resolution mass spectrometry to confidently identify each charge variant and strengthen the analytical method.

The approach delivered:

• Confident assignment of each cIEF peak to its corresponding molecular variant
• Structural evidence to support method robustness and validation
• Improved confidence in product characterization and charge variant analysis
• A stronger analytical package for GMP implementation and future comparability studies