Marcelino Varona Ortiz I received my B.S in Biology and Chemistry from Concordia University Nebraska and PhD in Analytical Chemistry from Iowa State University. Currently I am a Principal Scientist in the Synthetic Molecule Analytical Chemistry department at Genentech. I am a CMC analytical lead who is responsible for the control strategy and characterization of synthetic molecules within our portfolio. Over the last couple of years I have been using High Resolution Ion Mobility Mass Spectrometry as a tool to enable the characterization of a variety of small molecule compounds.

Traveling Wave Ion Mobility Spectrometry for the identification and quantitation of impurities in small molecule APIs

In this presentation, I will speak of our group's recent work using Traveling Wave Ion Mobility Spectrometry (TWIMS) coupled with High Resolution Mass Spectrometry (HRMS) to characterize impurities in small molecule drug candidates. In addition, we have implemented a workflow with Skyline to the enable quantitation of some of these impurities. The developed methods have enabled the significant reduction of analysis times when compared to traditional chromatographic methods.