Proteomics in biopharmaceutical industries

Proteomic tools have been integral to the biopharmaceutical industry since its inception, supporting both the discovery of new drugs and the production of recombinant therapeutic proteins. Mass spectrometry combined with liquid chromatography has proven to be an indispensable analytical approach for the characterization and analysis of therapeutic proteins. The relatively recent emergence of the Multi-Attribute Method, an advanced mass spectrometry-based analytical approach, is being increasingly incorporated in the biopharmaceutical industry for quality control and simultaneously monitor and quantify multiple quality attributes of therapeutic proteins, such as monoclonal antibodies and other biologics. The combination of Multi-Attribute Method with the analysis of intact proteins by mass spectrometry could replace the vast majority of traditional control techniques and become the essential platform to ensure the quality and safety of therapeutic proteins in the near future. SIGNIFICANCE: This review demonstrates the great importance of proteomics for the biopharmaceutical industry, both in the development of new drugs and in the production of recombinant proteins. Advances in mass spectrometry, along with liquid chromatography, will soon become a fundamental tool for quality control of therapeutic proteins.