Abstract
Antibody-based therapeutics constitute a major growth area in medicine today. However, antibodies as drugs present significant analytical challenges as they are large, complex and heterogenous molecules produced in living cells. The key attributes that affect safety, stability and efficacy must be identified and controlled to ensure regulatory compliance. Liquid Chromatography-Mass Spectrometry (LC-MS) is a powerful analytical technology that is well suited to the task of analyzing antibody-based therapeutics. LC-MS is used to characterize antibody features ranging from the relatively simple (e.g. intact molecular weight determination and post-translational modification analysis) to the complex (e.g., higher order structure analysis and epitope identification). Few other analytical technologies are as versatile as LC-MS for monitoring a wide range of attributes or as capable of keeping pace with the innovation happening today in biotherapeutic design. In this chapter we will provide an overview of the LC-MS methods currently used for the characterization of antibody-based therapeutics, with an emphasis on the analysis of post-translational modifications. We will also highlight some recent innovations, new technologies and trends that are likely to significantly impact the manner in which antibody-based therapeutics are analyzed in the future.
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