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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