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Research ArticleResearch

Processing Impact on Monoclonal Antibody Drug Products: Protein Subvisible Particulate Formation Induced by Grinding Stress

Benson Gikanga, Devon Roshan Eisner, Robert Ovadia, Eric S. Day, Oliver B. Stauch and Yuh-Fun Maa
PDA Journal of Pharmaceutical Science and Technology May 2017, 71 (3) 172-188; DOI: https://doi.org/10.5731/pdajpst.2016.006726
Benson Gikanga
1Pharmaceutical Processing and Technology Development and
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Devon Roshan Eisner
1Pharmaceutical Processing and Technology Development and
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Robert Ovadia
1Pharmaceutical Processing and Technology Development and
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Eric S. Day
2Late Stage Pharmaceutical Development, Genentech, Inc., South San Francisco, CA
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Oliver B. Stauch
1Pharmaceutical Processing and Technology Development and
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Yuh-Fun Maa
1Pharmaceutical Processing and Technology Development and
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  • For correspondence: maay@gene.com
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Reference

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    Mixing Monoclonal Antibody Formulations Using Bottom-Mounted Mixers—Impact of Mechanism and Design on Drug Product Quality. PDA J. Pharm. Sci. Technol. 2015, 69 (2), 284–296.
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    Protein Aggregation and Pioprocessing. AAPS J. 2006, 8 (3), E572–E579.
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PDA Journal of Pharmaceutical Science and Technology: 71 (3)
PDA Journal of Pharmaceutical Science and Technology
Vol. 71, Issue 3
May/June 2017
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Processing Impact on Monoclonal Antibody Drug Products: Protein Subvisible Particulate Formation Induced by Grinding Stress
Benson Gikanga, Devon Roshan Eisner, Robert Ovadia, Eric S. Day, Oliver B. Stauch, Yuh-Fun Maa
PDA Journal of Pharmaceutical Science and Technology May 2017, 71 (3) 172-188; DOI: 10.5731/pdajpst.2016.006726

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Processing Impact on Monoclonal Antibody Drug Products: Protein Subvisible Particulate Formation Induced by Grinding Stress
Benson Gikanga, Devon Roshan Eisner, Robert Ovadia, Eric S. Day, Oliver B. Stauch, Yuh-Fun Maa
PDA Journal of Pharmaceutical Science and Technology May 2017, 71 (3) 172-188; DOI: 10.5731/pdajpst.2016.006726
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  • Mechanistic Investigation on Grinding-Induced Subvisible Particle Formation during Mixing and Filling of Monoclonal Antibody Formulations
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Keywords

  • Bottom-mounted mixers
  • monoclonal antibody
  • LevMixer®
  • Mobius® mixer
  • JetMixer™
  • Filter fouling
  • Subvisible particles
  • Rotary piston pump

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