Quality Considerations for MAM for Therapeutic Proteins
The multi-attribute method (MAM) is a liquid chromatography-mass spectrometry (LC-MS) based peptide mapping approach used for the identification and quantitation of product quality attributes (PQAs) in therapeutic proteins. The U.S. FDA Center for Drug Evaluation and Research (CDER), Emerging Technology Program (ETP) has assessed the use of MAM in quality control environments and laboratory resources