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Research ArticleResearch

Filling of High-Concentration Monoclonal Antibody Formulations: Investigating Underlying Mechanisms That Affect Precision of Low-Volume Fill by Peristaltic Pump

Wendy Shieu, Dax Lamar, Oliver B. Stauch and Yuh-Fun Maa
PDA Journal of Pharmaceutical Science and Technology March 2016, 70 (2) 143-156; DOI: https://doi.org/10.5731/pdajpst.2015.005926
Wendy Shieu
Pharmaceutical Processing and Technology Development, Genentech, a member of the Roche Group, South San Francisco, CA
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Dax Lamar
Pharmaceutical Processing and Technology Development, Genentech, a member of the Roche Group, South San Francisco, CA
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Oliver B. Stauch
Pharmaceutical Processing and Technology Development, Genentech, a member of the Roche Group, South San Francisco, CA
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Yuh-Fun Maa
Pharmaceutical Processing and Technology Development, Genentech, a member of the Roche Group, South San Francisco, CA
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  • For correspondence: maay@gene.com
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References

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    Characterization of subvisible particle formation during filling pump operation of a monoclonal antibody solution. J. Pharm. Sci. 2011, 100 (10), 4198–4204.
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    1. Tyagi A. K.,
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    Cole-Parmer website, Reducing Pulsation in Peristaltic Pump Systems, http://www.coleparmer.com.cn/en/TECHINFO/techinfo.asp?openlist=A,A3,B,C,D,D1,D5,D6,D7,E,A1&htmlfile=ppumpsreduc_WP.htm&Title=Reducing+Pulsation+in+Peristaltic+Pumping+Systems (accessed July 10, 2015).
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    1. Shieu W.,
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    Filling of high-concentration monoclonal antibody formulations into pre-filled syringes: filling parameter investigation and optimization. PDA J. Pharm. Sci. Technol. 2014, 68 (2), 153–163.
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    1. Shieu W.,
    2. Stauch O. B.,
    3. Maa Y.-F.
    Filling of high-concentration monoclonal antibody formulations into pre-filled syringes: investigating formulation–nozzle interactions to minimize nozzle clogging. PDA J. Pharm. Sci. Technol. 2015, 69 (3), 417–426.
    OpenUrlAbstract/FREE Full Text
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    1. Castrejón-Pita A. A.,
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    3. Hutchings I. M.
    Breakup of liquid filaments. Phys. Rev. Lett. 2012, 108 (7), 074506.
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PDA Journal of Pharmaceutical Science and Technology: 70 (2)
PDA Journal of Pharmaceutical Science and Technology
Vol. 70, Issue 2
March/April 2016
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Filling of High-Concentration Monoclonal Antibody Formulations: Investigating Underlying Mechanisms That Affect Precision of Low-Volume Fill by Peristaltic Pump
Wendy Shieu, Dax Lamar, Oliver B. Stauch, Yuh-Fun Maa
PDA Journal of Pharmaceutical Science and Technology Mar 2016, 70 (2) 143-156; DOI: 10.5731/pdajpst.2015.005926

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Filling of High-Concentration Monoclonal Antibody Formulations: Investigating Underlying Mechanisms That Affect Precision of Low-Volume Fill by Peristaltic Pump
Wendy Shieu, Dax Lamar, Oliver B. Stauch, Yuh-Fun Maa
PDA Journal of Pharmaceutical Science and Technology Mar 2016, 70 (2) 143-156; DOI: 10.5731/pdajpst.2015.005926
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Keywords

  • Peristaltic pump
  • High-concentration monoclonal antibody
  • Fill weight precision
  • Suck-back
  • Liquid/nozzle interactions

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