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Electrospray-differential mobility analysis as an orthogonal tool to size-exclusion chromatography for characterization of protein aggregates.
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- المؤلفون: Guha, Suvajyoti1,2; Wayment, Joshua R.1; Tarlov, Michael J.1; Zachariah, Michael R.1,2
- المصدر:
Journal of Pharmaceutical Sciences. Jun2012, Vol. 101 Issue 6, p1985-1994. 10p. 1 Diagram, 2 Charts, 4 Graphs.
- الموضوع:
- معلومة اضافية
- نبذة مختصرة :
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 immunoglobulin Gs 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 is in good agreement with those determined by SEC. ES-DMA appears to have a higher resolution and lower limit of detection as compared with SEC. Thus, ES-DMA can potentially become an important orthogonal tool for characterization of nascent protein aggregates in the biopharmaceutical industry. © 2012 Wiley Periodicals, Inc. and the American Pharmacists Association J Pharm Sci 101:1985-1994, 2012 [ABSTRACT FROM AUTHOR]
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