Automation streamlines peptide map preparation, analysis and reporting for biotherapeutic antibody characterization

Area of Science:

• Biopharmaceutical Analysis
• Analytical Chemistry
• Protein Chemistry

Background:

• Peptide mapping is a crucial analytical method for biotherapeutic antibody characterization, providing insights into protein sequence, post-translational modifications (PTMs), and impurities.
• Standard peptide mapping workflows involve enzymatic digestion, liquid chromatography-mass spectrometry, and data analysis, which can be time-consuming.
• Specialized methods like Lys-C and Asp-N maps offer further structural details, including disulfide linkage and glycation analysis.

Purpose of the Study:

• To address the lengthy turnaround times associated with traditional peptide mapping workflows.
• To develop and implement automated solutions for protein digestion and data analysis in peptide mapping.
• To enhance the efficiency, accessibility, and user-friendliness of biotherapeutic antibody characterization.

Main Methods:

• Implementation of automated protein digestion protocols using liquid handlers.
• Development of a streamlined, compliance-ready data analysis workflow.
• Integration of automated sample preparation, data analysis, and reporting.

Main Results:

• Automation significantly reduced turnaround times for peptide mapping workflows.
• A throughput improvement of 30% was achieved, saving 2-3 days per week.
• Enhanced accessibility and user-friendliness of the peptide mapping process were observed.

Conclusions:

• Automated peptide mapping workflows offer a transformative solution for biopharmaceutical characterization.
• The implemented automation improves efficiency and reduces hands-on time, making complex analyses more accessible.
• This approach is essential for efficient drug product and process development, including critical quality attribute assessment.