We perform comprehensive and comparative side-by-side analytical and functional assessment between the innovator and biosimilar product using state of the art techniques.
Assessment of Purity, impurities, aggregation, charge variants, sequence confirmation, disulphide mapping, Identification and quantification of post translational modifications, higher order structure analysis and glycan profiling.
Functional assessment using target binding assay, cell based potency assay and mechanism of action assay.