Potential Inaccurate Quantitation and Sizing of Protein

Potential Inaccurate Quantitation and Sizing of Protein Aggregates by Size Exclusion Chromatography: Essential Need to use Orthogonal Methods to Assure the Quality of Therapeutic Protein Products

JOHN F. CARPENTER,¹ THEODORE W. RANDOLPH,² WIM JISCOOT,³ DAAN J.A. CROMMELIN,⁴ C. RUSSELL MIDDAUGH,⁵ GERHARD WINTER⁶

¹Department of Pharmaceutical Sciences, Center for Pharmaceutical Biotechnology, University of Colorado Health Sciences Center, Denver, CO 80262

²Department of Chemical and Biological Engineering, Center for Pharmaceutical Biotechnology, University of Colorado, Boulder, CO 80309

³Division of Drug Delivery Technology, Leiden/Amsterdam Center for Drug Research (LACDR), Leiden University, Leiden, The Netherlands

⁴Department of Pharmaceutics, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands

⁵Department of Pharmaceutical Chemistry, The University of Kansas, Lawrence, Kansas 66047

⁶Department of Pharmacy, Ludwig Maximilians University, 81377 Munich, Germany

PUBLICATION: Journal of Pharmaceutical Sciences. 99(5): 2200-2208. (2010)
DOI: 10.1002/jps.21989

LINK TO ARTICLE: http://onlinelibrary.wiley.com/doi/10.1002/jps.21989/abstract

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