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|Author(s):||Suvajyoti S. Guha; Joshua R. Wayment; Michael J. Tarlov; Michael R. Zachariah;|
|Title:||Electrospray ‹ Differential Mobility Analysis as an Orthogonal Tool to Size Exclusion Chromatography for Characterization of Protein Aggregates|
|Published:||March 12, 2012|
|Abstract:||The biopharmaceutical industry characterizes and quantifies aggregation of protein therapeutics using multiple analytical techniques to cross validate results. Here we demonstrate the use of electrospray-differential mobility analysis (ES-DMA), a gas-phase and atmospheric pressure ion-mobility method for characterizing protein aggregates. Two immunoglobulins (IgGs) are systematically heat treated to induce aggregation and characterized using size exclusion chromatography (SEC) and ES-DMA. Although ES-DMA is a gas phase characterization method, we find that aggregation kinetic rate constants determined by ES-DMA to be in excellent agreement with those determined by SEC. It is also found that ES-DMA is more capable of resolving aggregates of IgGs than SEC. The higher resolution of ES-DMA and a limit of detection two orders of magnitude lower than the SEC potentially make it a powerful tool for characterization of nascent protein aggregates in the biopharmaceutical industry.|
|Citation:||Journal of Pharmaceutical Sciences|
|Pages:||pp. 1985 - 1994|
|Keywords:||immunoglobulins, heat-treat, ES-DMA, SEC, rate constant, protein aggregates|
|Research Areas:||Electrospray Differential Mobility Analysis (ES-DMA), Nanotechnology, Characterization, Nanometrology, and Nanoscale Measurements|
|DOI:||http://dx.doi.org/10.1002/jps.23097 (Note: May link to a non-U.S. Government webpage)|
|PDF version:||Click here to retrieve PDF version of paper (356KB)|