Multi-Attribute Method Analysis In Biopharmaceutical Development

By Cédric Mesmin, Head of Innovation for Biologics, Jérôme Haustant, Innovation Expert Analytical/Mass Spectrometry, and Xavier Czeszak, Process Validation Analytical Manager, Millipore CTDMO Services, Martilliac, France

This application note delves into the transformative impact of Multi-Attribute Method (MAM) on the biopharmaceutical industry. Authored by experts from Millipore CTDMO Services, it highlights how MAM, a next-generation analytical method, optimizes the development and manufacturing of recombinant protein therapeutics. By integrating liquid chromatography and mass spectrometry (LC-MS), MAM provides a comprehensive analysis of product quality attributes (PQAs) to ensure precise quantification and characterization of proteins.

The evolution of analytical methods emphasizes MAM's superiority over traditional techniques. It showcases MAM's ability to streamline workflows, enhance regulatory compliance, and mitigate risks by providing detailed molecular insights. Additionally, MAM supports Quality by Design (QbD) principles, linking critical process parameters (CPPs) to critical quality attributes (CQAs), thus facilitating process optimization and validation. MAM's role in tech transfer, process development, and process validation demonstrates its fit-for-purpose performance through high specificity, precision, and accuracy.

Read the full application note to gain a deeper understanding of how MAM can revolutionize your biopharmaceutical processes.