General Description

LC-ESI-MS/MS peptide mapping is a crucial technique for the analysis of biologics, particularly in the characterization and quality control under ICHQ6B for biopharmaceuticals. This method combines liquid chromatography, electrospray ionization, and tandem mass spectrometry to provide detailed information about protein structure and modifications. The technique involves enzymatic digestion of proteins, typically using trypsin, followed by chromatographic separation of the resulting peptides. These peptides are then ionized and analyzed by mass spectrometry.

The method provides

• Confirming the primary structure (amino acid sequence)
• Characterization of post-translational modifications (PTMs)
• Detecting and localizing sequence variants
• Determination of N- & O-glycosylation
• Determination of disulfide linkages 

This data is essential for

• Quality control and batch release of biologics
• Stability evaluation of reference standards
• Process monitoring in biopharmaceutical production
• Comparability studies between different batches or products

Advantages for Biologics Analysis

• High specificity and sensitivity, detection of minor modifications
• Comprehensive profile of a biologic in a single analysis
• Orthogonal tool to support primary structure analyses at the intact or protein subunit level
• Potential for high-throughput analysis with optimized workflows