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.
Culham Science Centre