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Quantitative Glycopeptide Standard for Accurate Monosaccharide or Sialic Acid Quantitation

Ludger Ltd.
12 Dec 2012

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Quantitative sialic acid or monosaccharide analysis is an important step for developers and manufacturers of biologic drugs. Regulators are putting increasing pressure on companies to perform accurate glycoprofiling on their biopharmaceuticals. These analyses fall within ICH guidelines Q6B and Q5E for comparability studies during product development and after major manufacturing changes. Furthermore, the recent EMA monograph on monoclonal antibodies and forthcoming USP chapters on glycosylation analysis reinforce the need to perform glycoprofiling throughout the drug life cycle. Until now the difficulty with accurately quantifying sialic acids or monosaccharides has been the lack of quantitative standards.

Ludger Ltd. has produced a purified glycopeptide standard, the first in a range of Ludger BioQuant™ quantitative standards, which can be used as an internal standard and positive control when performing sialic acid or monosaccharide analyses in house. This particular Ludger BioQuant™ Standard is a complex biantennary N-linked glycan terminating in two N-acetylneuraminic acids.


Purity of >90% has been assessed by HPLC, correct mass identity assessed by MALDI mass spectrometry. The exact amount of material has been determined by quantitative NMR (qNMR) and quantitative monosaccharide analysis (MA). Quantity values by qNMR and MA agree within 90-110%. MA is traceable to internationally accepted references from USP and dispensed using NIST traceable labware. qNMR is traceable to a NIST SRM traceable CRM analyzed to the ISO 17025 standard. A detailed certificate of analysis is given for each standard. This contains comprehensive documentation, lot-specific values, expiration date and storage information.

The BioQuant GPEP-A2G2S2 standard can be used during the sialic acid or monosaccharide release and labeling process. This will enable you to check the efficiency of glycan release, labeling and recovery and will give you confidence in the accuracy of your sialic acid or monosaccharide measurements.

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UHPLC and HPLCHigh performance liquid chromatography (HPLC) and ultra high performance liquid chromatography (UHPLC), also known as UPLC, are analytical techniques used to separate, identify and quantitate components of complex mixtures including biological samples such as proteins and lipids as well as chemical mixtures of pesticides, drugs and oils. Both techniques are liquid chromatographic methods but differ by operating pressures (HPLC < 6000 psi < UHPLC ). Components of HPLC and UHPLC systems include columns, detectors, pumps, autosamplers and column heaters. Explore a range of UHPLC and HPLC columns for your specific sample needs including reverse phase, normal phase, ion exchange, HILIC, ion exclusion and size exclusion columns. For more specialized HPLC, explore FPLC, countercurrent LC and simulated moving bed systems. Find the best UHPLC and HPLC equipment in our peer reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.Mass SpectrometryMass spectrometry (MS) is a powerful analytical technique used to identify and quantify molecules based on the mass-to-charge ratio of gas-phase ions. It provides detailed information about the structure, composition, and properties of compounds and is widely used across fields such as environmental monitoring, materials science, drug discovery and development, food and beverage testing, and wider chemical research. Key MS techniques include tandem mass spectrometry (MS/MS), liquid chromatography–mass spectrometry (LS-MS) and inductively coupled plasma (ICP-MS). Choosing from these wide range of techniques and technologies can be a daunting task, so keep up to date with scientific applications, performance expectations, and customer reviews here all in one place. Visit our product directory to receive quotes direct from the manufacturer. AntibodiesAntibodies are used in techniques such as confocal and fluorescence microscopy, flow cytometry, ELISA, ELISPOT, immunohistochemistry, western blotting and immunopreciptation. Select specific antigen reactivity, high specific affinity, low non-specific binding, monoclonal or polyclonal, primary or secondary antibodies and associated conjugates such as an enzyme or dye for visualization.GlycobiologyGlycobiology encompasses research into the biological functions, synthesis and structures of glycans, including glycoproteins, glycolipids, proteoglycans and free oligosaccharides. Mass spectrometers and their software are commonly used in the study of glycobiology, along with structure predicting tools, chromatography and NMR.Process ChemistryProcess chemistry is an important stage of drug development for scaling-up drug production or chemical synthesis reactions. It is useful for optimizing economical and efficient drug production. Process chemistry uses reactors and pump systems as well as reagents, standards and buffers.GlycoproteinsGlycosylationMonoclonal AntibodiesMonoclonal antibodies (mAbs) are lab-made molecules that can bind to specific antigens on cells, making them highly effective in treating cancers, autoimmune diseases, and infections. These targeted therapies are transforming the treatment landscape for many conditions. Browse our peer-reviewed product directory to find monoclonal antibodies for research and clinical applications; compare products, check reviews, and get pricing directly from manufacturers.Sialic AcidsGlycans

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Quantitative Glycopeptide Standard for Accurate Monosaccharide or Sialic Acid Quantitation