New 2D-LC/MS approaches for the analysis of in-process samples and for the characterisation of mAbs in a regulated environment

Monoclonal antibodies (mAbs) represent a significant proportion of biopharmaceuticals currently under development. Monitoring these molecules throughout the manufacturing process is essential to assess their purity, structural integrity and critical quality attributes. However, mass spectrometry-based characterisation typically requires purified samples, making preparation steps time-consuming.

Technical Highlights

• Automated 2D-LC/MS analysis of mAbs directly from complex matrices without prior sample preparation
• Characterisation possible at both intact and subunit levels using online purification, desalting, digestion and reduction workflows
• Protein A affinity chromatography enables direct analysis of mAbs present in cell culture media and other complex mixtures
• Online IdeS digestion combined with optional DTT reduction generates well-defined subunits for detailed structural characterisation
• Fully automated workflow implemented on a GMP-compliant 2D-LC/MS platform with mass spectrometric detection

Supporting your analytical strategy

The presented workflows are designed to streamline mAb characterisation by reducing manual intervention while maintaining access to detailed mass spectrometric information.

• Eliminate manual purification prior to MS analysis
• Enable efficient monitoring of mAbs directly within complex production samples
• Facilitate identification of structural modifications such as oxidation and other quality attributes
• Provide detailed molecular information to support process optimisation and QC-oriented analyses

Together, these capabilities help simplify analytical workflows while improving access to actionable characterisation data.