High-Resolution Mass Spectrometry for Biopharmaceutical Characterisation

Biopharmaceuticals, particularly recombinant protein therapeutics, require rigorous analytical characterisation to ensure their identity, purity and structural integrity. Among the most powerful tools supporting this process is high-resolution mass spectrometry (MS), which enables detailed molecular analysis of complex biologics.

At Sygnature Discovery, MS is fully integrated into our protein production workflows and routinely supports client projects across all stages of biopharmaceutical development. In this study, we applied MS to characterise a recombinant protein-based Active Pharmaceutical Ingredient (API) and investigate two impurity peaks detected during reversed-phase HPLC analysis.

Why It Matters

Using a combination of intact mass spectrometry, peptide mapping and high-resolution workflows, we confirmed the API’s identity and identifies the structures of two key contaminants observed during production. These insights enable:

• Confirmation of the correct API molecular weight and sequence
• Greater understanding of impurity origins to refine downstream processes
• Generation of critical data to support regulatory submissions