Effect of ambient light on IgG1 monoclonal antibodies during drug product processing and development

[Display omitted] Photostability studies are standard stress testing conducted during drug product development of various pharmaceutical compounds, including small molecules and proteins. These studies as recommended by ICH Q1B are carried out using no less than 1.2× 106lux-hours in the visible regi...

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Veröffentlicht in:	European journal of pharmaceutics and biopharmaceutics 2016-03, Vol.100, p.38-46
Hauptverfasser:	Sreedhara, Alavattam, Yin, Jian, Joyce, Michael, Lau, Kimberly, Wecksler, Aaron T., Deperalta, Galahad, Yi, Li, John Wang, Y., Kabakoff, Bruce, Kishore, Ravuri S.K.
Format:	Artikel
Sprache:	eng
Schlagworte:	Ambient light Antibodies, Monoclonal - chemistry Antibodies, Monoclonal - radiation effects Chemistry, Pharmaceutical - methods Drug Discovery - methods Drug product processing Drug Stability HunterLab Immunoglobulin G - chemistry Immunoglobulin G - radiation effects Light - adverse effects Mild light Oxidation-Reduction Photodegradation Photooxidation Photostability Relevant stress
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