March 12–15, 2019
Meet Genedata experts at CASSS AT Europe in Dublin
Don't miss the opportunity to see how Genedata solutions efficiently support the whole biopharmaceutical R&D workflow, including screening and protein engineering, expression and purification, characterization and analysis of protein therapeutics, cell line design and development, bioprocess optimization, and quality control of biologicals.
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Glycosylation Profiling of Biopharmaceuticals using Cutting-edge Mass Spectrometry Techniques and an Advanced Data Processing Platform
Lucio Manzi, PhD, Associate Researcher - Structural Characterization Lab., Protein Chemistry Department
Thursday, March 14 | 12:00–12:30 pm
As the most common post-translational modification, glycosylation plays a crucial role in protein structure and function. This makes characterization of carbohydrate moieties in biopharmaceuticals especially important because glycosylation impacts not only on a drug’s physiochemical properties and thermal stability, but also its reactivity with receptors, immunogenicity, and circulating half-life. Therefore, despite its challenges, detailed glycan analysis is a pre-requisite for achieving complete in-depth characterization of biopharmaceutical products, thereby ensuring their safety and efficacy.
Because it can deliver in-depth, information-rich data, mass spectrometric (MS) methods are ideally suited for analysis of glycosylation in biopharmaceuticals. Using MS techniques, glycosylation can be investigated at the protein or subunit level (intact mass analysis), (glyco)peptide level (peptide mapping), or the glycan level (released glycan analysis). Although established methods exist for all these approaches, there is no “one-size-fits-all” methodology; neither for data acquisition nor data processing.
We present results obtained using cutting-edge MS techniques and demonstrate how analysis at all three levels — protein, peptide, and glycan — can be combined to provide a comprehensive characterization of glycosylation in biopharmaceuticals. This characterization is significantly facilitated and streamlined by using the Genedata Expressionist® enterprise mass spectrometry software platform, which provides the flexibility required to adapt to any MS-based analytical approach and offers intelligent automated data workflows for routine MS-based monitoring.
Automated Data Processing and Analysis for Quality Monitoring of Biotherapeutics by Multi-attribute Method (MAM)
An Automated Approach for Comprehensive Characterization and Quantification of Low-abundance Sequence Variants in a Standard Monoclonal Antibody