Role and importance of glycosylation

Glycosylation is a post-translational modification which plays an important role in the bioactivity, stability, and immunogenicity of therapeutic glycoproteins. Unlike transcription, it is a non-template-driven process whose outcomes are highly variable. Given its impact on drug safety, regulators classify glycosylation as a Critical Quality Attribute of biopharmaceuticals. Therefore, manufacturers are required to monitor and control it at every stage of the drug manufacturing process.

Regulatory delays due to non-compliant reporting as well as out-of-spec batch failures can lead to significant financial losses. This is something our expert team can help you with. We have extensive experience in glycan analysis including glycoconjugates, biopharmaceuticals and biological specimens.


Sample types

Ludger has over 20 years of expertise with analysing glycosylation (including N- and O- glycosylation) from a variety of sample types including:

Ludger Glycan Analysis - Sample type: Biopharmaceuticals

Biopharmaceuticals: monoclonal antibodies (mAbs), Fc fusion proteins, vaccines, and glycoprotein hormones such as follicle stimulating hormone (FSH), and erythropoietin (EPO).

Ludger Glycan Analysis - Sample type: Cells

Cells: mammalian cell lines, bacterial cell components

Ludger Glycan Analysis - Sample type: Biological fluids, tissues and others

Biological samples: patient’s plasma, fluids, tissues and others

Ludger Glycan Analysis - Sample type: SARS-CoV-2 infected cell lines

Infected samples and cell lines: COVID-19 patient samples and cell lines



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 the successful delivery of the information you need.


Regulatory requirements & Ludger's approach

EMA guideline on development, production, characterisation and specification for monoclonal antibodies and related products states:

"The carbohydrate content (neutral sugars, amino sugars and sialic acids) should be determined. In addition, the structure of the carbohydrate chains, the oligosaccharide pattern (antennary profile), the glycosylation site(s) and occupancy should be analysed.

Typically, monoclonal antibodies have one N-glycosylation site on each heavy chain located in the Fc region. The light chain is usually not glycosylated. However, additional glycosylation site(s) in the heavy chains may occur, and thus their presence or absence should be confirmed. Glycan structures should be characterised, and particular attention should be paid to their degree of mannosylation, galactosylation, fucosylation and sialylation. The distribution of the main glycan structures present (often G0, G1 and G2) should be determined.

Higher-order structure of the monoclonal antibody should be characterised by appropriate physicochemical methodologies."

ICH Q6B guideline states:

"For glycoproteins, the carbohydrate content (neutral sugars, amino sugars, and sialic acids) is determined. In addition, the structure of the carbohydrate chains, the oligosaccharide pattern (antennary profile), and the glycosylation site(s) of the polypeptide chain are analyzed, to the extent possible."

At Ludger, we use a systematic approach aligned with current regulatory guidelines to support drug developers and researchers. Our system has three broad steps:

  1. Specification of Glycosylation Critical Quality Attributes (GCQAs) (i.e. those glycosylation parameters that most influence the drug product's safety and efficacy profiles).
  2. Implementation of appropriate, affordable glycoprofiling modules to measure the GCQAs throughout the drug's life cycle.
  3. Interpretation of the glycoprofiling data and taking appropriate action if the product falls out of specification (OOS) or trends towards OOS.
Regulatory requirements Ludger Glycan Analysis Services
Quantitative Monosaccharide Analysis
Quantitative Sialic Acid Analysis
Glycan Profiling Analysis
Glycan Antennary Profiling Analysis
Linkage Analysis
Detailed Glycan Characterisation
Glycosylation Site Analysis
GCQAs Ludger Glycan Analysis Services
Degree of Mannosylation
Degree of Galactosylation
Distribution of G0, G1 and G2
Degree of Fucosylation
Degree of Sialylation/Charge distribution
Human vs. Non-Human Sialic Acids
Detection and Relative Quantitation of N-glcayns Containing the Galα1-3Gal Epitope
Compliance documentation for GMP

Ludger's glycoprofiling programmes:

Hover over each module to zoom (or pinch to zoom on touch devices), and click for more information/to visit webpages for each module.

MONOSACCHARIDE and SIALIC ACID - PROFILING

Ludger Glycan Analysis - Quantitative Monosaccharide Analysis Ludger Glycan Analysis - Quantitative Sialic Acid Analysis

LEVEL 1 - PROFILING

Ludger Glycan Analysis - Level 1 - HILIC glycan profiling Ludger Glycan Analysis - Level 1 - WAX glycan profiling Ludger Glycan Analysis - Level 1 - MALDI glycan profiling

LEVEL 2 - CHARACTERISATION

Ludger Glycan Analysis - Level 2 - HILIC glycan charactersiation Ludger Glycan Analysis - Level 2 - WAX glycan charactersiation Ludger Glycan Analysis - Level 2 - LC MS/MS glycan charactersiation

LEVEL 3 - CHARACTERISATION

Ludger Glycan Analysis - Level 3 - Site Occupancy Analysis Ludger Glycan Analysis - Level 3 - Site Specific Glycosylation Analysis

MONOSACCHARIDE and SIALIC ACID - PROFILING

Ludger Glycan Analysis - Quantitative Monosaccharide Analysis Ludger Glycan Analysis - Quantitative Sialic Acid Analysis

LEVEL 1 - PROFILING

Ludger Glycan Analysis - Level 1 - HILIC glycan profiling Ludger Glycan Analysis - Level 1 - WAX glycan profiling Ludger Glycan Analysis - Level 1 - MALDI glycan profiling

LEVEL 2 - CHARACTERISATION

Ludger Glycan Analysis - Level 2 - HILIC glycan charactersiation Ludger Glycan Analysis - Level 2 - WAX glycan charactersiation Ludger Glycan Analysis - Level 2 - LC MS/MS glycan charactersiation

LEVEL 3 - CHARACTERISATION

Ludger Glycan Analysis - Level 3 - Site Occupancy Analysis Ludger Glycan Analysis - Level 3 - Site Specific Glycosylation Analysis


Ludger's glycoprofiling programmes:

Hover over each module to zoom (or pinch to zoom on touch devices), and click for more information/to visit webpages for each module.


Ludger Glycan Analysis - Profiling and Characterisation
Ludger Glycan Analysis - Quantitative Monosaccharide Analysis Ludger Glycan Analysis - Quantitative Sialic Acid Analysis
Ludger Glycan Analysis - Level 1 - HILIC glycan profiling Ludger Glycan Analysis - Level 1 - WAX glycan profiling Ludger Glycan Analysis - Level 1 - MALDI glycan profiling
Ludger Glycan Analysis - Level 2 - HILIC glycan charactersiation Ludger Glycan Analysis - Level 2 - WAX glycan charactersiation Ludger Glycan Analysis - Level 2 - LC MS/MS glycan charactersiation
Ludger Glycan Analysis - Level 3 - Site Occupancy Analysis Ludger Glycan Analysis - Level 3 - Site Specific Glycosylation Analysis

Ludger works closely with clients to design and execute appropriate glycoprofiling programmes and can work up to GMP standard. Ludger can perform these analyses for you and/or transfer and validate these optimised glycoprofiling methods to your laboratories.


Ludger Brochure - Glycan Analysis Services

Glycan Analysis Services Brochure

Mandarin Version (CN)

An overview of the innovative technologies being used within Glycan Analysis Services to analyse glycosylation of complex glycoproteins and details on how you can fast-track your glycan analysis workflows. Click on the brochure to either download or share it.





Contacts

Glycan Analysis Services

Dr. Radoslaw P. Kozak

Dr. Radoslaw Kozak
Head of Glycoprofiling
rad.kozak@ludger.com

Book a meeting, discuss your requirements with our experts (CDA/MSA if required) and get a quote.