Meeting report on protein particles and immunogenicity of therapeutic proteins: Filling in the gaps in risk evaluation and mitigation

This meeting was successful in achieving its main goals: (1) summarize currently available information on the origin, detection, quantification and characterization of sub-visible particulates in protein products, available information on their clinical importance, and potential strategies for evalu...

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Veröffentlicht in:Biologicals 2010-09, Vol.38 (5), p.602-611
Hauptverfasser: Carpenter, John, Cherney, Barry, Lubinecki, Anthony, Ma, Stacey, Marszal, Ewa, Mire-Sluis, Anthony, Nikolai, Thomas, Novak, Jeanne, Ragheb, Jack, Simak, Jan
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Sprache:eng
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