Biotherapeutic glycoproteins with complex glycosylation patterns have the potential to easily fall out of specification with changes in biomanufacturing processes. To meet regulatory demands such as ICH Q5E and ICH Q6B, manufacturers must carefully characterize glycosylation of proteins and its relation to the clinical activity of the medication. The complete analysis of a glycoprotein provides information on the primary structure of the oligosaccharides as well as their variation at individual glycosylation sites. See our complete solutions for glycan profiling of biotherapeutic proteins.
Answer the question - how many glycoforms are in my product? Perform rapid analysis of protein glycosylation at the intact level. Determine intact glycoform composition quickly and simply to make process-level decisions on the fly. Combine rapid separations with accurate glycoprotein mass spectrometry (MS) for confidence in process-related glycosylation differences.
Answer the question - which N-glycans are in my product and at what level? Utilize comprehensive capabilities for the analysis of N-linked glycosylation. Perform released N-glycan analysis and characterization by liquid chromatography (LC) and LC-MS. Assign an unequivocal glycan structure to every glycoform by performing glycan release and carbohydrate substructural analysis.
Answer the question - which N-glycans and O-glycans are in my product and at what level? Rapidly determine both O-linked and N-linked glycosylation in biopharmaceuticals. Identify and quantify unlabeled released N-glycans and O-glycans by UHPLC with charged aerosol detection (CAD) or mass spectrometry (MS).
Answer the question - where do the glycans reside in my product?Analogous to standard peptide mapping analysis workflows, glycopeptide analysis can yield glycosylation site information with advanced LC-MS/MS fragmentation techniques such as electron transfer dissociation (ETD) and higher energy C-trap dissociation (HCD) using Thermo Scientific™ Orbitrap™-based mass spectrometry.
Answer the question - what is the composition of the glycans in my product? To determine and understand the structure of a glycoprotein, the individual monosaccharides and sialic acids present must be identified and quantified. Sialic acids are located terminally on the oligosaccharide chains and are more likely to interact with other proteins and receptors. Analysis helps you to determine the identities and quantities of the sialic acid species in your biopharmaceutical product, an important factor that may influence serum half-life and immunogenicity. Ion chromatography (IC) is the workhorse technique for this application, allowing simple workflows with sensitive performance and no labeling requirements.
Biotherapeutic proteins, which include antibodies, are becoming the fastest growing category of drugs due to their efficacy for patient health. The complex nature of these large molecules brings major new challenges to the pharmaceutical scientist. Read about the series of four simple workflow solutions we've developed, based on leading technology platforms.