Quantitative Monosaccharide Analysis (QMA) is important. Regulators want you to do it to prove consistency of your drug’s glycosylation 1 – but current, widely used, monosaccharide composition methods are unreliable 2. This causes serious problems for regulatory compliance and demonstrating comparability of your product throughout its life cycle.

Ludger’s LT-MONO-96 kit addresses these issues. It is designed for accurate, reliable quantitative monosaccharide analysis of biopharmaceuticals and glycosylated media components within both R&D and QC labs.

The LT-MONO-96 kit contains the reagents and protocol for release and fluorescent labeling of neutral and N-acetylated monosaccharides from therapeutic glycoproteins produced in mammalian expression systems, the isolated oligosaccharides or the cell culture media. The labeled monosaccharides can be analysed on your standard HPLC systems using a LudgerSep R2 column or your own favorite C18 column.

Accuracy and reliability are aided by robust chemistry, pure reagents, and calibration using Ludger’s BioQuantTM NIST-traceable external and internal quantitative monosaccharide standards.

The kit has been validated following ICH Q2(R1) guidelines and beta-tested in the field. Precision values were excellent compared to HPAE-PAD, GC-MS and other commonly used monosaccharide quantitation methods with CVs of 5-10% across all monosaccharide species.

More information on this kit, (Cat# LT-MONO-96) is available at www.ludger.com/mono