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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;
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Thomas Roedl
2Manufacturing Science and Technology, F. Hoffmann-La Roche Ltd., Kaiseraugst, Switzerland; and
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Ada Hui
3Late Stage Pharmaceutical Development, Genentech, a member of the Roche Group, South San Francisco, CA
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Stephanie Knueppel
2Manufacturing Science and Technology, F. Hoffmann-La Roche Ltd., Kaiseraugst, Switzerland; and
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Kirk Eppler
1Pharmaceutical Processing and Technology Development, Genentech, a member of the Roche Group, South San Francisco, CA;
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Siegfried Lehnert
2Manufacturing Science and Technology, F. Hoffmann-La Roche Ltd., Kaiseraugst, Switzerland; and
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Yuh-Fun Maa
1Pharmaceutical 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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PDA Journal of Pharmaceutical Science and Technology: 72 (4)
PDA Journal of Pharmaceutical Science and Technology
Vol. 72, Issue 4
July/August 2018
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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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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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  • Development and Validation of a Customized Amplex UltraRed Assay for Sensitive Hydrogen Peroxide Detection in Pharmaceutical Water
  • Vapor-Phase Hydrogen Peroxide Uptake by Silicone Tubing and Primary Packaging Components during Protein Drug Product Aseptic Filling: Impact of Pretreatment and Sterilization Process
  • Stability Evaluation of Hydrogen Peroxide Uptake Samples from Monoclonal Antibody Drug Product Aseptically Filled in Vapor Phase Hydrogen Peroxide-Sanitized Barrier Systems: A Case Study
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Keywords

  • Vapor phase hydrogen peroxide
  • monoclonal antibody
  • VPHP uptake
  • Drug product quality
  • Quality-by-Design
  • Drug product filling
  • Vaporized hydrogen peroxide
  • VHP

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