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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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Article Information

vol. 71 no. 3 172-188
DOI 
https://doi.org/10.5731/pdajpst.2016.006726
PubMed 
27789805

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online May 26, 2017.

Article Versions

  • previous version (October 27, 2016 - 16:53).
  • You are viewing the most recent version of this article.
Copyright & Usage 
© PDA, Inc. 2017

Author Information

  1. Benson Gikanga1,
  2. Devon Roshan Eisner1,
  3. Robert Ovadia1,
  4. Eric S. Day2,
  5. Oliver B. Stauch1 and
  6. Yuh-Fun Maa1⇑
  1. 1Pharmaceutical Processing and Technology Development and
  2. 2Late Stage Pharmaceutical Development, Genentech, Inc., South San Francisco, CA
  1. * Corresponding Author: Yuh-Fun Maa, Genentech, a member of the Roche Group, 1 DNA Way South San Francisco, CA 94080. Telephone: +1-650-225-3499; Fax: +1-650-742-1504; e-mail: maay{at}gene.com
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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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Keywords

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

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