The glycosylation of proteins and lipids can influence both biological structure and function. As such control and measurement of glycosylation is a key step in the development of biotherapeutics. Ludger’s glycoprofiling technology and services can be used
to monitor glycosylation throughout the drug development lifecycle. This information can be used to support IND submissions for innovator and biosimilar drugs, in the quality control of approved biopharmaceuticals and for Quality by Design (QbD) studies. By
working closely with our clients we can identify appropriate analytical workflows that best fit their requirements. We also offer method transfer and training modules for clients who wish to perform glycoprofiling in their own laboratories.
The role of glycosylation in health and disease is an area of medical research that has gained considerable interest and is actively pursued at Ludger. Glycomics analyses seek to understand how glycans relate to particular biological events; this is enabled
by the high throughput analysis of patient materials and the use of bioinformatics within our Research and Development Programmes.
Ludger’s Head Office, R&D, Analytical Glycoprofiling services and Production laboratories are located at the Culham Science Centre, Oxfordshire, UK. Ludger also has a subsidiary office in Shanghai, China.
All work that Ludger performs is carried out in compliance with its Quality Management System (QMS) which is based on the ISO 9001:2008 framework.
What we offer:
Ludger manufactures a comprehensive range of products for clients to use in their glycoprofiling workflows, and which are applicable to LC, MS, LC-MS, or CE. These can be used for ICH-compliant glycoprofiling of biopharmaceuticals throughout the drug development
* Glycoprofiling Services
Ludger’s analytical glycoprofiling services utilise LC and MS to study a wide range of therapeutic glycoproteins (to support QbD, clone selection, process optimisation, scaleup and comparability studies). We can alsotransfer optimised methods to client laboratories.
Our services for glycan characterization include: sialic acid profiling (to compare levels of NeuAc (NANA) vs NeuGc (NGNA)), quantitative monosaccharide analysis, profiling of N- and O-glycans by a range of orthogonal HPLC and MS methods and detailed exoglycosidase
sequencing. We can also perform high throughput analysis of mAbs.
* Research and Development
Ludger are involved in a number of innovative research programmes dedicated to improving glycan analysis for biopharmaceuticals, as well as Medical Glycomics and Precision Medicine. Projects include studies of chronic diseases such as cancers and inflammatory
conditions. Around half of our R&D is funded by EU grants as part of collaborative research programmes (including Innovate UK).