Glycan Analysis Services
Ludger's scientists have extensive experience in detailed glycan analysis and their expertise can be applied to both biologic drugs (biopharmaceuticals) and glycoconjugates relevant to medical research. The latter includes Medical Glycomics for Precision Medicine and we are involved in a number of pan-European collaborative R&D programmes in this field which are listed on the following page: www.ludger.com/research-and-development.
Our glycoanalytical support includes consultancy and custom glycoprofiling services as well as method development, validation and transfer. This flexible model enables our clients to get a quick start to expert glycan analysis. For instance, initially you could outsource your glycoprofiling work to us, followed by the transfer of the optimised methods and technology into your laboratory
Services include: Monosaccharide analysis, sialic acid analysis, intact released (N- and O-) glycan analysis, site specific glycan analysis.
In drug development (innovator, biosimilar and biobetter drugs) the glycoprofiling information we provide can be used for early stage development (e.g. clone selection), process optimisation (including production scale up), characterisation to support regulatory (e.g. IND) submissions, batch comparability studies and product lot release QC. This information will help address safety, efficacy, product consistency, stability, half-life, regulatory compliance, patent issues and comparability.
Examples of drugs we regularly work with are: Monoclonal antibodies, glycoprotein hormones (e.g. follicle stimulating hormone (FSH) and erythropoietin (EPO)) and virus vaccines. We can also analyse glycosphingolipids and heparin digests.
Detailed Characterisation of Biopharmaceutical Glycosylation
(Monosaccharide Analysis, Sialic Acid Analysis, Intact Released Glycan Analysis, Site Specific Glycan Analysis)
Method Validation
Method Transfer
High Throughput Analysis
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