Cobra offers comprehensive packages for the physicochemical characterisation of mammalian products, and where appropriate more than one analytical procedure employing different analytical principles will be applied.
Characterisation packages are adapted to the requirements of the product in order to comply with ICH guidelines, especially for antibodies and biosimilars.
Physicochemical properties are examined via molecular weight or size, alongside isoform pattern and electrophoretic profiling. Mass spectrometry is employed for the characterisation of the intact protein and, when possible, its sub-domains. Peptide mapping, with mass spectrometry detection, is performed to confirm amino acid sequence and disulphide linkages and to study post-translational modifications, e.g. site specific glycosylation, glycosylation site occupancy, truncations, deamidation, and oxidation. N-glycan profiling is performed using high-resolution chromatography combined with fluorescence detection, as required, mass spectrometry is employed to confirm the identity of the glycans.