Characterization and Monitoring of Post Translational Modifications Using Dedicated MAM Software
Esme Candish, Ph.D.
Application Scientist, SCIEX
Development and production of biopharmaceuticals is becoming increasingly complex and challenging. The assessment of post-translational modifications including deamidation, oxidation, glycosylation and glycation must be assessed to understand their impact on safety and efficacy.
The Multiple Attribute Methodology (MAM) places greater rigor on the use of LC-MS peptide map experiments as an orthogonal technique for the characterization and monitoring of biopharmaceutical attributes. Using MAM, an extensive range of modifications can be identified, while the ability to localize modifications may provide greater confidence in the correlation of characterization data with downstream outcomes. Further, an LC-MS approach using MAM provides a purity assessment as specified and un-specified impurities related to the biotherapeutic production can be analyzed.
Presented here is the use of High-Resolution Accurate Mass data processed using BioPharmaView™ 3.0 Software for characterization and quantification of post-translational modifications of a biotherapeutic. Further, the quantification of specified impurities and the ability to detect un-specified impurities using new peak detection will be discussed.