کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
2486375 1114382 2009 18 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
Detection of Protein Aggregates by Sedimentation Velocity Analytical Ultracentrifugation (SV-AUC): Sources of Variability and Their Relative Importance
موضوعات مرتبط
علوم پزشکی و سلامت داروسازی، سم شناسی و علوم دارویی اکتشاف دارویی
پیش نمایش صفحه اول مقاله
Detection of Protein Aggregates by Sedimentation Velocity Analytical Ultracentrifugation (SV-AUC): Sources of Variability and Their Relative Importance
چکیده انگلیسی
Sedimentation velocity analytical ultracentrifugation (SV-AUC) has found application in the biopharmaceutical industry as a method of detecting and quantifying protein aggregates. While the technique offers several advantages (i.e., matrix-free separation and minimal sample handling), its results exhibit a high degree of variability relative to orthogonal size-sensitive separation techniques such as size exclusion chromatography (SEC). The goal of this work is to characterize and quantify the sources of variability that affect SV-AUC results, particularly size distributions for a monoclonal antibody monomer/dimer system. Contributions of individual factors to the overall variability are examined. Results demonstrate that alignment of sample cells to the center of rotation is the most significant contributing factor to overall variability. The relative importance of other factors (e.g., temperature equilibration, time-invariant noise, meniscus misplacement, etc.) are quantified and discussed. © 2008 Wiley-Liss, Inc. and the American Pharmacists Association J Pharm Sci 98:3522-3539, 2009
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Journal of Pharmaceutical Sciences - Volume 98, Issue 10, October 2009, Pages 3522-3539
نویسندگان
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