Mass Spectrometry in characterising biopharmaceuticals?

The biotherapeutics market has enjoyed exceptional growth in recent years. Comprehensive characterisations of biopharmaceuticals have become increasingly important, especially for regulatory submissions. With improvements in performance, sample throughput and sensitivity, Mass Spectrometry (MS) is replacing traditional methods in an increasing number of applications such as identification of Post-Translational Modifications (PTM) and glycosylation studies. However, the sheer volume of data produced by modern MS instruments has led to a bottleneck in data processing. This article gives an overview of MS-based techniques currently used for the characterisation and analysis of biotherapeutics. It will specifically detail recent developments in bioinformatics that offer innovative approaches for greatly streamlining these processes. As an example, the article will discuss an alternative process for batch control.