Comparison of analytical methods to detect instability of etanercept during thermal stress testing

Several analytical methods were used to detect instability in three batches of etanercept showing significant differences in sensitivity in the order of: Bis-Ans fluorescence > HP-SEC > DLS > Far-UV CD spectroscopy > ELISA > Second derivative UV spectroscopy. The aim was comparing the...

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Veröffentlicht in:	European journal of pharmaceutics and biopharmaceutics 2011-06, Vol.78 (2), p.213-221
Hauptverfasser:	Maarschalkerweerd, Andreas van, Wolbink, Gert-Jan, Stapel, Steven O., Jiskoot, Wim, Hawe, Andrea
Format:	Artikel
Sprache:	eng
Schlagworte:	Aggregation Antirheumatic Agents - chemistry Bis-ANS Chromatography, Gel Chromatography, High Pressure Liquid Conformational changes Drug Stability Electrophoresis, Polyacrylamide Gel Enbrel Enzyme-Linked Immunosorbent Assay Etanercept Extrinsic fluorescence Hot Temperature Immunoglobulin G - chemistry Protein stability Receptors, Tumor Necrosis Factor - chemistry Spectrometry, Fluorescence
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