A Game-Changing Quality Control Strategy: The Multi-Attribute Method

This presentation explores multi-attribute method (MAM) capabilities and offers a comprehensive overview of its application in characterizing and monitoring the quality attributes of therapeutic proteins. As protein-based drugs become increasingly complex, traditional analytical methods often struggle to provide a holistic understanding of product quality. MAM, however, emerges as a game-changer, offering a streamlined approach to simultaneously detect, identify, quantify, and monitor multiple product quality attributes (PQAs) and critical quality attributes (CQAs) in a single mass spectrometry run.

The technical intricacies of MAM will be examined, including its two distinct phases: characterization and monitoring. By leveraging the power of liquid chromatography and mass spectrometry (LC-MS), MAM enables the evaluation of quality attributes at the amino acid level, replacing multiple traditional methods and facilitating the detection of unexpected modifications. Moreover, participants will gain insights into the increasing adoption of MAM within the biopharmaceutical industry, supported by retrospective analyses of Biological License Applications illustrate how MAM enhances understanding of the product and process, accelerates development timelines, and refines control strategies focused on specific CQAs.

Practical implementation of MAM in various facets of pharmaceutical development and manufacturing will be assessed, including process development, batch release, and stability analysis. Additionally, the session will highlight MAM's potential as a process analytical technology tool to enhance analytical efficiency and ensure product quality throughout the lifecycle.