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Mass Spectrometric Analysis of Intact Complex Biotherapeutics

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The benefit of therapeutic antibodies is their ability to be inherently more selective than traditional small-molecule pharmaceuticals through specific binding activities, lower toxicity, and higher efficacy. And the proof of their benefits is in the numbers: The U.S. Food & Drug Administration approved 68 such therapeutics by the beginning of 2017,and more than 50 are being evaluated in late-stage clinical studies for a range of indications.

Because mAbs are produced from cell lines and fermentation processes, they are fundamentally less pure than traditional chemically synthesized products and are subject to possible degradation and chemical modifications throughout their manufacturing and storage. This lack of purity and the microheterogeneity inherent in the nature of the molecule (due to, for example, glycosylation) require significant and robust characterization not only during discovery and research but also throughout the drug development process, quality control, and lot release to ensure safety, efficacy, and consistency.

This whitepaper explores how LC/MS analysis of intact therapeutic antibodies can be performed with high accuracy and sensitivity down to subnanogram levels for molecular weight confirmation and assessment of isoform pattern. For the analysis of more complex molecules, such as antibody-drug conjugates, native mass spectrometry is beneficial to characterize the sample and obtain the accurate drug-to-antibody ration.

Key Learning Objectives

  • Create workflows for intact protein analysis
  • Analyze protein masses under denaturing and native conditions
  • Develop workflows for antibody subunits
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