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Research ArticleResearch

Filling of High-Concentration Monoclonal Antibody Formulations into Pre-Filled Syringes: Filling Parameter Investigation and Optimization

Wendy Shieu, Sarah A. Torhan, Edwin Chan, Aaron Hubbard, Benson Gikanga, Oliver B. Stauch and Yuh-Fun Maa
PDA Journal of Pharmaceutical Science and Technology March 2014, 68 (2) 153-163; DOI: https://doi.org/10.5731/pdajpst.2014.00973
Wendy Shieu
Pharmaceutical Processing and Technology Development, Genentech, a member of the Roche Group, South San Francisco, CA
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Sarah A. Torhan
Pharmaceutical Processing and Technology Development, Genentech, a member of the Roche Group, South San Francisco, CA
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Edwin Chan
Pharmaceutical Processing and Technology Development, Genentech, a member of the Roche Group, South San Francisco, CA
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Aaron Hubbard
Pharmaceutical Processing and Technology Development, Genentech, a member of the Roche Group, South San Francisco, CA
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Benson Gikanga
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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Article Information

vol. 68 no. 2 153-163
DOI 
https://doi.org/10.5731/pdajpst.2014.00973
PubMed 
24668602

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online March 25, 2014.

Copyright & Usage 
© PDA, Inc. 2014

Author Information

  1. Wendy Shieu,
  2. Sarah A. Torhan,
  3. Edwin Chan,
  4. Aaron Hubbard,
  5. Benson Gikanga,
  6. Oliver B. Stauch and
  7. Yuh-Fun Maa*
  1. Pharmaceutical Processing and Technology Development, Genentech, a member of the Roche Group, South San Francisco, CA
  1. ↵*Corresponding Author: Genentech, a member of the Roche Group, 1 DNA Way South San Francisco, CA 94080. Telephone: 650-225-3499; Fax: 650-742-1504; email: maay{at}gene.com
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PDA Journal of Pharmaceutical Science and Technology: 68 (2)
PDA Journal of Pharmaceutical Science and Technology
Vol. 68, Issue 2
March/April 2014
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Filling of High-Concentration Monoclonal Antibody Formulations into Pre-Filled Syringes: Filling Parameter Investigation and Optimization
Wendy Shieu, Sarah A. Torhan, Edwin Chan, Aaron Hubbard, Benson Gikanga, Oliver B. Stauch, Yuh-Fun Maa
PDA Journal of Pharmaceutical Science and Technology Mar 2014, 68 (2) 153-163; DOI: 10.5731/pdajpst.2014.00973

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Filling of High-Concentration Monoclonal Antibody Formulations into Pre-Filled Syringes: Filling Parameter Investigation and Optimization
Wendy Shieu, Sarah A. Torhan, Edwin Chan, Aaron Hubbard, Benson Gikanga, Oliver B. Stauch, Yuh-Fun Maa
PDA Journal of Pharmaceutical Science and Technology Mar 2014, 68 (2) 153-163; DOI: 10.5731/pdajpst.2014.00973
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Keywords

  • Prefilled syringe
  • High-concentration monoclonal antibody
  • Peristaltic pump
  • Suck-back
  • Formulation drying

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