Biosimilars Testing Services

We deliver biosimilar analytical comparability programs that provide highly relevant early stage characterisation and later stage comparative data. These programs evaluate and compare all pertinent features of the biosimilar product and are based on the ICH Q6B. Programs encompass many analytical techniques and provide information on physiochemical properties and structural features including primary, secondary and HOS and assessment of PTM and cell-based assays to determination of biological potency. We also deploy a range of mass spectrometry and chromatographic techniques to assess process impurities and product related impurity profiles.
Our GLP immunochemistry capabilities include PK, TK, PD, immunogenicity, efficacy and safety biomarker studies with diverse immunochemistry technologies (e.g. ligand binding assays), and functional (e.g., enzymatic and cell-based assays) assay platforms.