Multi-Attribute Methods For Biopharmaceutical Analysis

The adoption of LC-MS-based multi-attribute method (MAM) analysis for routine monitoring of biotherapeutic variation has progressed greatly over the last five years. The ability to directly assess the molecular attributes that contribute to efficacy, safety, stability, and process robustness is enabling analysts and their organizations to obtain more data without the ambiguity of traditional chromatographic and electrophoretic assays that measure product variation indirectly. In many cases, this data is generated with greater sensitivity and dynamic range than these legacy assays, furthering the discussion whether they complement or eventually replace these traditional analyses in development, manufacturing, and quality organizations.

Learn about the capabilities and adoption of MAM workflows within the biopharmaceutical industry, including the movement of LC-MS in biopharmaceutical development, the deployment of MAM assays within process science, manufacturing, and quality organizations, and the trends as the industry moves MAM analysis forward. Additionally, explore MAM resources for process and product control of biotherapeutic proteins.