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Research ArticleResearch

Manufacturing of High-Concentration Monoclonal Antibody Formulations via Spray Drying—the Road to Manufacturing Scale

Benson Gikanga, Robert Turok, Ada Hui, Mayumi Bowen, Oliver B. Stauch and Yuh-Fun Maa
PDA Journal of Pharmaceutical Science and Technology January 2015, 69 (1) 59-73; DOI: https://doi.org/10.5731/pdajpst.2015.01003
Benson Gikanga
aPharmaceutical Processing and Technology Development;
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Robert Turok
cSPX Flow Technology Systems, Inc., Elkridge, MD
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Ada Hui
bLate-Stage Pharmaceutical Development, Genentech, Inc., a member of the Roche Group, South San Francisco, CA; and
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Mayumi Bowen
aPharmaceutical Processing and Technology Development;
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Oliver B. Stauch
aPharmaceutical Processing and Technology Development;
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Yuh-Fun Maa
aPharmaceutical Processing and Technology Development;
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  • For correspondence: maay@gene.com
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PDA Journal of Pharmaceutical Science and Technology: 69 (1)
PDA Journal of Pharmaceutical Science and Technology
Vol. 69, Issue 1
January/February 2015
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Manufacturing of High-Concentration Monoclonal Antibody Formulations via Spray Drying—the Road to Manufacturing Scale
Benson Gikanga, Robert Turok, Ada Hui, Mayumi Bowen, Oliver B. Stauch, Yuh-Fun Maa
PDA Journal of Pharmaceutical Science and Technology Jan 2015, 69 (1) 59-73; DOI: 10.5731/pdajpst.2015.01003
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Keywords

  • Spray drying
  • Monoclonal antibody (mAb)
  • Powder collection yield
  • Powder reconstitution
  • Water content
  • Scale-up

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Manufacturing of High-Concentration Monoclonal Antibody Formulations via Spray Drying—the Road to Manufacturing Scale
Benson Gikanga, Robert Turok, Ada Hui, Mayumi Bowen, Oliver B. Stauch, Yuh-Fun Maa
PDA Journal of Pharmaceutical Science and Technology Jan 2015, 69 (1) 59-73; DOI: 10.5731/pdajpst.2015.01003

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