Modern mass spectrometry is essential for the characterization of complex drug products, including peptide and protein therapeutics as well as both naturally and synthetically derived complex mixture drugs. Recombinantly produced peptides and proteins are difficult to characterize because of their high levels of heterogeneity. This heterogeneity stems largely from variations in both post-translational and chemical modifications. Similarly, many complex drug products are composed of heterogeneous mixtures of highly related species. These complex products present a challenge in characterization as highly accurate techniques are needed in order to discern between the different species.<br/>Recent advances in high resolution accurate mass (HRAM) instrumentation have allowed for the elucidation of the closely related species within these heterogeneous products. These modern instruments also allow for the detection of degradation products, modifications and/or impurities based on mass deviations. Mass spectrometry is traditionally coupled with liquid chromatography to better separate and characterize distinct species. Modern separation technologies, including ion mobility spectroscopy, are being increasingly used in conjunction with mass spectrometry for faster separations to further improve characterization. This seminar will include an overview of the importance of mass spectrometry for the analysis of these products followed by several case studies reviewing the use of mass spectrometry for their characterization within FDA laboratories.

Modern applications of mass spectrometry in the analysis of biopharmaceuticals and other complex drug products

254th National Meeting (2017)

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