Antibody Product Analysis Service Leaflet

Antibody Product Analysis

Expert Analytical Services

in Accordance with Regulatory Guidelines Antibody products should be characterised according to ICH and FDA guidelines. M-Scan provides a full GLP/cGMP analysis package for product characterisation and identification of post translational modifications, which include: Structural characterisation and confirmation Amino acid sequence Amino acid composition N- and C- terminal sequence



N-terminal sequencing (automated Edman) MS/MS peptide sequencing

Peptide map Sulphydryl groups and disulphide bridges Carbohydrate structure



Monosaccharide composition analysis Oligosaccharide profiling by HPAEC-PAD and MS Linkage analysis Glycosylation site determination

Deamidation Oxidation Physicochemical properties Molecular weight or size



Gel electrophoresis MALDI-TOF or ES-Q-TOF-MS

Isoform pattern Extinction coefficient Electrophoretic pattern



Including CE

Liquid Chromatographic patterns



Reversed Phase Size Exclusion Ion-Exchange profiling

Spectroscopic profiles



Circular Dichroism NMR

Aggregation



Analytical Ultracentrifugation (AUC) SEC/MALLS

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In-depth Analytical Characterisation of Antibody Products