Recent Advances in Biologic Therapeutic N-Glycan Preparation Techniques and Analytical Methods for Facilitating Biomanufacturing Automation.

This study focuses on recent advances in biologic therapeutic n-glycan preparation techniques and analytical methods for facilitating biomanufacturing automation.. The research employs high-performance liquid chromatography (HPLC) techniques to address analytical challenges in the biopharmaceutical field. N-glycosylation is a post-translational modification that occurs during the production of monoclonal antibody (mAb) therapeutics. During production of mAb based therapeutics the use of various hosts and cell culture additives attribute to glycan heterogeneity. The safety and efficacy of monoclonal antibodies with mechanism of actions that utilize Fc effector functions...

This study focuses on recent advances in biologic therapeutic n-glycan preparation techniques and analytical methods for facilitating biomanufacturing automation.. The research employs high-performance liquid chromatography (HPLC) techniques to address analytical challenges in the biopharmaceutical field. N-glycosylation is a post-translational modification that occurs during the production of monoclonal antibody (mAb) therapeutics. During production of mAb based therapeutics the use of various hosts and cell culture additives attribute to glycan heterogeneity. The safety and efficacy of monoclonal antibodies with mechanism of actions that utilize Fc effector functions... Research Background and Significance N-glycosylation is a critical post-translational modification in the production of monoclonal antibody (mAb) therapeutics, influencing their safety, efficacy, and mechanism of action, particularly through Fc effector functions. The heterogeneity of N-glycans arises from variations in host cell lines and cell culture additives used during biomanufacturing, complicating the characterization and quality control of these biologics. As the biopharmaceutical industry increasingly strives for automation and high-throughput analytical workflows, there is a pressing need for robust, reliable, and sensitive analytical methods. This study addresses these challenges by focusing on recent advances in N-glycan preparation and high-performance liquid chromatography (HPLC) techniques that facilitate streamlined analysis and support biomanufacturing automation. Experimental Design and Methodology The research employs HPLC-based analytical strategies to characterize N-glycans derived from mAb therapeutics. Key to this approach is the development and validation of chromatographic meth