Role and importance of glycosylation
Protein glycosylation can play an important role in bioactivity, stability, biological half-life and immunogenicity of a biopharmaceutical. Glycosylation is a post-translational modification and, unlike transcription, is a non-template-driven enzymatic modification process, so glycosylation can change with alterations to production conditions. Glycosylation can have a significant effect on the clinical safety and efficacy of biopharmaceuticals. Issues with glycans have caused great financial, legal and regulatory problems for those companies who have not dealt effectively with their product's glycosylation.
Analysis of glycosylation is important not only in biopharmaceutical research but also in clinical and biological research where changes in glycosylation have been associated with many states of health and disease providing prognostic and diagnostic information.
Ludger has over 20 years of expertise with analysing glycosylation (including N- and O- glycosylation) from a variety of sample types including:
Biopharmaceuticals: monoclonal antibodies (mAbs), glycoprotein hormones (e.g. follicle stimulating hormone (FSH) and erythropoietin (EPO), Fc fusion proteins, vaccines
Cells: mammalian cell lines, bacterial cell components
Biological fluids, tissues and others
COVID-19 patient samples (e.g. plasma, tissues)
SARS-CoV-2 infected cell lines
Ludger has been offering custom analytical services to suit your individual requirements since 1999.
We listen and respond with dedicated tailored solutions. Our data and customised reports are used:
- in QbD studies and early stages of drug development
- in process optimisation and production scale-up
- in comparability studies (biosimilars, biobetters)
- to support regulatory submissions
- for lot release of drug batches during biomanufacturing
- in research & method development
Our philosophy is to work with you in a partnership to ensure successful delivery of the information you need.