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Rapid MS-Based Profiling, Fingerprinting, and Speciation of Polymeric Excipients in Biotherapeutic Drug Products

Polymeric excipients such as polysorbate 20/80 and poloxamer 188, which are used in formulation of biotherapeutics, share the  polyethylene oxide building block. Charge-reduction mass spectrometry (MS) coupled with two-dimensional ion density mapping has been used for rapid profiling, fingerprinting, and speciation of such polymeric excipients. 

This approach has proven to be a fast and effective tool for the visualization of intact polymeric species but has inherent challenges due to the heterogeneity of the polymeric species and the complexity of the resulting MS data. 

 

Discover how Genedata Expressionist empowers scientists at MSD with:

  • A tailored data processing solution utilizing custom MS peak libraries.
  • Intuitive visualizations enabling fast, in-depth characterization of polysorbates.
  • An accelerated workflow for the identification of polymer excipients in biotherapeutic drug products.

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