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Ludger

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Ludger

Ludger is a bioscience company specialising in technology for the measurement and control of biopharmaceutical glycosylation. Clients include leading pharmaceutical and biotechnology companies throughout the world.

Ludger’s glycoanalysis technology can help you measure and control glycosylation reliably throughout your therapeutic’s life cycle – from clone selection and regulatory submissions to process optimisation, scale-up and major manufacturing changes.

Regulatory submissions and quality by design

If you are implementing quality by design (QbD) for your drug programme we can help to determine and prioritise the Glycosylation Critical Quality Attributes (GCQAs) for your biopharmaceutical and to measure and compare them at key stages during product development and biomanufacturing – so you can demonstrate comparability of glycosylation throughout your drug’s life, satisfy the FDA and EMEA and avoid costly mistakes.

Custom glycoprofiling services for biopharmaceuticals

Ludger’s glycoprofiling services are used worldwide by companies developing and manufacturing new and follow-on (biosimilars and biobetters) biological therapeutics. The information is important for early stage development, process optimization, characterization to support regulatory submissions, batch comparability studies and product lot release QC.

Ludger can design and execute appropriate glycoprofiling programmes for your therapeutic and transfer optimised glycoprofiling methods to your laboratories. Our services include: sialic acid profiling (to compare levels of NeuAc vs NeuGc), quantitative monosaccharide analysis, Level 1 and Level 2 profiling of N- and O-glycans by a range of orthogonal HPLC and MS methods and detailed exoglycosidase sequencing. Following glycoprofiling customers are provided with a detailed report.

Products for glycoprofiling

Our products allow you to perform glycoprofiling in your laboratory and can be used to analyse and monitor glycosylation in your laboratory throughout all the stages of the drug life cycle.

Our catalogue includes kits for glycan release, labelling and clean-up. We also sell labelled/unlabelled glycans, glycan HPLC columns, endoglycosidases (e.g. PNGaseF), exoglycosidases, glycoprotein standards and glycoprotein libraries.

Contact details

Ludger Ltd,
Culham Science Centre
Abingdon
Oxfordshire
OX14 3EB
UK

e-mail: info@ludger.com
Tel: +44 (0)1865 409523
Fax: +44 870 163 4620
Website: www.ludger.com

Comparability Studies

We can perform analyses for clients wishing to perform batch-to-batch comparisons for QC or to compare a biosimilar with an innovator drug.

Glycoprofiling services at Ludger are led by Ludger's Head of Glycoprofiling, Dr. Louise Royle. If you would like more informationplease visit our website www.ludger.com or contact Dr. Claire Morgan (Business Development Manager) claire.morgan@ludger.com.

Detailed Structural Analysis of Glycans

Detailed structural analysis of N-or O-glycans is performed using exoglycosidase sequencing with HPLC in combination MALDI MS.

Glycoprofiling services at Ludger are led by Ludger's Head of Glycoprofiling, Dr. Louise Royle. If you would like more informationplease visit our website www.ludger.com or contact Dr. Claire Morgan (Business Development Manager) claire.morgan@ludger.com.

Glycoprofiling of N-glycans

This service determines the overall N-glycan profile with classification and relative quantitation of the major N-glycan species. The glycan releases are performed in triplicate with HPLC runs in triplicate to allow precision statistics.

Up to three different methods of HPLC analysis are available as well as MALDI MS analysis.Glycoprofiling services at Ludger are led by Ludger's Head of Glycoprofiling, Dr. Louise Royle. If you would like more informationplease visit our website www.ludger.com or contact Dr. Claire Morgan (Business Development Manager) claire.morgan@ludger.com.

Glycoprofiling of O-glycans

This service determines the overall O-glycan profile with relative quantitation of the major O-glycan species. The glycan releases will be performed in triplicate with HPLC runs in triplicate to allow precision statistics.

Up to three different methods of HPLC analysis are available as well as MALDI MS analysis.Glycoprofiling services at Ludger are led by Ludger's Head of Glycoprofiling, Dr. Louise Royle. If you would like more informationplease visit our website www.ludger.com or contact Dr. Claire Morgan (Business Development Manager) claire.morgan@ludger.com.

LudgerClean™ Systems for Clean-Up of Glycans

LudgerClean™ glycan clean up systems have been developed to maximise the efficiency of glycan detection. Cartridges are available to clean up glycans once they have been released from glycoproteins or following labelling.

For more information about this or any other Ludger product/serviceplease visit our website, www.ludger.com .

LudgerLiberate™ Kits for Release of Glycans

Ludger have developed two kits for performing chemical glycan release from glycoproteins; the LudgerLiberate™ Hydrazinolysis kit for release of N- and/or O-linked glycans from glycoproteins, and the Orela kit for O-linked glycan release.

For more information about this or any other Ludger product/service please visit our website, www.ludger.com.

LudgerSep™ HPLC columns

A range of HPLC columns are available for analysis of labeled glycans.

These include the following:LudgerSep N: Amide columns for glycan analysisLudgerSep C: Anion Exchange columns for charge separation of glycansLudgerSep R1: Reverse Phase column for analysis of DMB-labelled sialic acids or 2AB labeled glycansLudgerSep R2: Reverse Phase column for analysis of 2AA-labelled monosaccharidesFor more information about this or any other Ludger product/service please visit our website,…

LudgerTag™ Kits for Labelling of Glycans

LudgerTag™ labelling kits provide the means to label glycans with a fluorophore thereby aiding detection following separation by HPLC using LudgerSep™ columns. Kits available include 2AB labeling kit (Cat# LT-KAB-A2), 2AA labeling kit (Cat# LT-KAA-A2). Also available within this range are the LudgerTag™ DMB Sialic Acid Release and Labeling Kit (Cat# LT-KDMB-A1) and the LudgerTag™ Monosaccharide Release and Labeling Kit (Cat# LT-MONO-96).

For more information about this or any other Ludger product/service please visit our website, www.ludger.com.
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