Mass spectrometric analysis of therapeutic proteins and complex biological samples

• Online Access: http://hdl.handle.net/2047/d20003083

Recombinant DNA technology has been widely used for therapeutic protein production in pharmaceutical industry. In order to enhance product yield and efficiency, investigations and studies have been made to understand of host cell culture transcriptomics, proteomics and metabolomics. The protein product is expressed together with a complex mixture of host cell proteins from cell cultures. As a result of the variability of the cellular production process and following manufacturing stages, protein drugs are heterogeneous because of post-translational modifications (PTMs) as well as sequence variants. Comprehensive analyses of protein drugs as well as the complex biological system during the manufacturing procedures are critical and challenging to the biopharmaceutical industry. Liquid chromatography coupled with online tandem mass spectrometry (LC-MS) has been developed as a very powerful analytical tool for therapeutic protein characterization and proteomics studies.