The glycosylation of biologics is an important factor in pharmacological functions such as efficacy, safety, and biological activity and is easily affected by subtle changes in the cellular environment. Hence, comprehensive and in-depth glycomic characterization of biological products should be performed to ensure product quality and process consistency prior to regulatory approval, but it is still highly challenging due to the glycoheterogeneity produced by enzymatic machinery. High-resolution mass spectrometry (MS) has recently emerged as the premier tool for glycan analysis in biotherapeutics. Using the accurate mass measurements provided by high-resolution MS, the compositions of even large, complex glycans can easily be determined. When combined with a nano-LC separation, differentiation of structural isomers also becomes a possibility. These components, together, provide a comprehensive picture of biotherapeutic glycosylation including micro- and macro-heterogeneity. Lastly, DeepY, an AI technology-based platform developed for comparability assessment and quality verification of biotherapeutics, will be introduced.

MS-based analytical platform for comprehensive glycomic characterization of glycoprotein-based therapeutics

Fall 2022 abstracts, posters, and presentations will launch in mid-September.

ACS Fall 2022

The official archive and repository for all ACS Meetings & Expositions abstracts and select posters or presentations.