N-Glycan Characterization via LC-MS
N-glycosylation is a post-translational modification (PTM) that plays a crucial role in monoclonal antibody (mAb) effector functions and is, therefore, classified as a critical quality attribute (CQA) that requires comprehensive, precise and accurate characterization and monitoring.
N-glycosylation of mAbs (and other therapeutic proteins) has the potential to influence the pharmacodynamics (PD) and pharmacokinetic (PK) behavior, overall therapeutic efficacy, and safety of the product because certain N-glycan species can cause adverse immune reactions. Some glycoforms are capable of inducing such effects even at very low abundances, meaning a highly sensitive assay that can identify and quantify glycan species below 0.1% relative abundance is essential.
Typically, glycosylation in mAbs is isolated to a single site in the Fc-region, however, related products such as fusion proteins often exhibit more elaborate glycan profiles that extend beyond the Fc-region and across multiple N-glycosylation sites. Generally, the species observed at these sites are larger, with increased variation and complexity.
In this webinar, we will discuss our LC-MS approach to N-glycan characterization for a variety of biopharmaceutical products as well as best practices for overcoming some of the most common product-related challenges.