Cobra has an advanced analytical portfolio, providing full support for our customers, including assay transfer, the development of cell-based potency assays, and expert product characterisation.
We offer comprehensive packages for the physicochemical characterisation of protein products, and where appropriate more than one analytical procedure employing different analytical principles will be applied. The characterisation packages are adapted to the requirements of the product in order to comply with ICH guidelines especially for antibodies and biosimilars.
Physicochemical properties can be 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.
Our Quality Assurance (QA) team provides Quality Control (QC) release testing of Drug Substance & Drug Product.
Cleaning validation and raw materials testing is undertaken to ensure the highest standards are maintained for all of our customers’ programmes.
Shipping studies to determine stability for product transportation including variations in temperature, humidity, light and oxygen levels can be undertaken as required.