IgG particle formation during filling pu
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Anil K. Tyagi; Theodore W. Randolph; Aichun Dong; Kevin M. Maloney; Carl Hitsche
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Article
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2009
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John Wiley and Sons
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English
⚖ 232 KB
This study investigated factors associated with vial filling with a positive displacement piston pump leading to formation of protein particles in a formulation of an IgG. We hypothesized that nanoparticles shed from the pump's solution-contact surfaces nucleated protein aggregation and particle for