Innovator product and biosimilar, both reference standards characterization requires a broad spectrum of analytical methods for comprehensive and comparative assessment of drug purity, potency, identity, and stability. We employ a state of the art technologies to achieve this goal. These include mass spectrometry for primary structure, peptide mapping (MAM) for amino acid sequencing and post translational modifications, glycoform profiling, extinction coefficient determination, chromatographic methods, biophysical characterization by DSC, FTIR, CD, AUC, DLS, SEC-MALS and intrinsic/extrinsic fluorescence, cIEF to determine isoelectric point and charge variants and general analytical methods for pH, colour, clarity, osmolality and particulate matter.
