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.

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.

Glycan Analysis Services Brochure

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.