Confirming Structural Consistency With HDX-MS

A biopharmaceutical company needed to demonstrate that an optimized manufacturing process had no impact on the higher-order structure of its monoclonal antibody. While traditional analytical techniques confirmed overall similarity, they lacked the sensitivity to detect subtle local conformational changes needed for regulatory confidence.

Solvias applied hydrogen-deuterium exchange mass spectrometry (HDX-MS) to provide a high-resolution assessment of protein structure and process comparability.

The approach delivered:

• High-sensitivity confirmation of structural comparability at the peptide level
• Detection of subtle conformational differences beyond the capabilities of traditional HOS techniques
• Greater confidence in process changes supporting regulatory submissions
• Rapid analysis using a validated HDX-MS platform with no assay development required