MAM 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.

This eBook compiles several recent application notes generated by the Biopharmaceutical Scientific Operations Team at Waters. They illustrate key attribute monitoring workflows that have been developed to improve and streamline MAM analysis of biotherapeutic proteins.