Research ArticleResearch
Vapor Phase Hydrogen Peroxide Decontamination or Sanitization of an Isolator for Aseptic Filling of Monoclonal Antibody Drug Product—Hydrogen Peroxide Uptake and Impact on Protein Quality
Aaron Hubbard, Thomas Roedl, Ada Hui, Stephanie Knueppel, Kirk Eppler, Siegfried Lehnert and Yuh-Fun Maa
PDA Journal of Pharmaceutical Science and Technology July 2018, 72 (4) 348-366; DOI: https://doi.org/10.5731/pdajpst.2017.008326
Aaron Hubbard
1Pharmaceutical Processing and Technology Development, Genentech, a member of the Roche Group, South San Francisco, CA;
Thomas Roedl
2Manufacturing Science and Technology, F. Hoffmann-La Roche Ltd., Kaiseraugst, Switzerland; and
Ada Hui
3Late Stage Pharmaceutical Development, Genentech, a member of the Roche Group, South San Francisco, CA
Stephanie Knueppel
2Manufacturing Science and Technology, F. Hoffmann-La Roche Ltd., Kaiseraugst, Switzerland; and
Kirk Eppler
1Pharmaceutical Processing and Technology Development, Genentech, a member of the Roche Group, South San Francisco, CA;
Siegfried Lehnert
2Manufacturing Science and Technology, F. Hoffmann-La Roche Ltd., Kaiseraugst, Switzerland; and
Yuh-Fun Maa
1Pharmaceutical Processing and Technology Development, Genentech, a member of the Roche Group, South San Francisco, CA;
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In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 72, Issue 4
July/August 2018
Vapor Phase Hydrogen Peroxide Decontamination or Sanitization of an Isolator for Aseptic Filling of Monoclonal Antibody Drug Product—Hydrogen Peroxide Uptake and Impact on Protein Quality
Aaron Hubbard, Thomas Roedl, Ada Hui, Stephanie Knueppel, Kirk Eppler, Siegfried Lehnert, Yuh-Fun Maa
PDA Journal of Pharmaceutical Science and Technology Jul 2018, 72 (4) 348-366; DOI: 10.5731/pdajpst.2017.008326
Vapor Phase Hydrogen Peroxide Decontamination or Sanitization of an Isolator for Aseptic Filling of Monoclonal Antibody Drug Product—Hydrogen Peroxide Uptake and Impact on Protein Quality
Aaron Hubbard, Thomas Roedl, Ada Hui, Stephanie Knueppel, Kirk Eppler, Siegfried Lehnert, Yuh-Fun Maa
PDA Journal of Pharmaceutical Science and Technology Jul 2018, 72 (4) 348-366; DOI: 10.5731/pdajpst.2017.008326
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