Validation of LC–MS Multi-Attribute Method Supporting Biopharma Process Characterization
Multi-attribute method (MAM) approaches to characterizing and monitoring the production of biopharmaceuticals offer the ability to replace multiple analytical technologies with a single mass spectrometry-based (MS) analysis. However, routine use of MAM in this environment means overcoming various scientific, technological, and methodological challenges. These challenges include managing large amounts of data, producing unbiased audited results, and meeting process validation requirements. This case study describes how scientists at one major biopharmaceuticals manufacturer have implemented a flexible software solution with automated workflows that has enabled them to address these challenges and reap the benefits of using MAM analyses routinely.