Validation of an LC-MS Multi-Attribute Method (MAM) 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 (MS) analysis. Assessing multiple critical quality attributes (CQAs) at the molecular level delivers a comprehensive understanding of the end product; ultimately enabling a true quality-by-design approach to biotherapeutic development.

Key learning objectives

• Learn how automating MAM can dramatically increase productivity in quality monitoring of biopharmaceuticals
• Learn how biopharma scientists are validating multi-attribute method approaches
• Learn how knowledge gained throughout a biopharmaceutical’s development can be leveraged to improve product quality

Presenters

• Cédric Mesmin, Ph.D., Mass Spectrometry Specialist/Innovation coordinator, Development-Microbial Unit, Merck Biodevelopment SAS, Martillac, France
• Lucie Manache-Alberici, Pharm.D., Analytical Development Supervisor, Microbial Unit, Merck Biodevelopment SAS, Martillac, France
• Jonathan Jones, Ph.D., Business Development—Expressionist, Genedata Ltd., Cambridge, UK