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PDA Journal of Pharmaceutical Science and Technology

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Research ArticleResearch

Vapor-Phase Hydrogen Peroxide Uptake by Silicone Tubing and Primary Packaging Components during Protein Drug Product Aseptic Filling: Impact of Pretreatment and Sterilization Process

Devon Roshan Eisner, Aaron Hubbard, Kirk Eppler, Vassia Tegoulia and Yuh-Fun Maa
PDA Journal of Pharmaceutical Science and Technology September 2019, 73 (5) 443-458; DOI: https://doi.org/10.5731/pdajpst.2019.009928
Devon Roshan Eisner
Pharmaceutical Processing and Technology Development, Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080
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Aaron Hubbard
Pharmaceutical Processing and Technology Development, Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080
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Kirk Eppler
Pharmaceutical Processing and Technology Development, Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080
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Vassia Tegoulia
Pharmaceutical Processing and Technology Development, Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080
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Yuh-Fun Maa
Pharmaceutical Processing and Technology Development, Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080
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  • For correspondence: maay@gene.com
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Article Information

vol. 73 no. 5 443-458
DOI 
https://doi.org/10.5731/pdajpst.2019.009928
PubMed 
31004039

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online October 9, 2019.

Article Versions

  • previous version (April 19, 2019 - 08:50).
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© PDA, Inc. 2019

Author Information

  1. Devon Roshan Eisner,
  2. Aaron Hubbard,
  3. Kirk Eppler,
  4. Vassia Tegoulia and
  5. Yuh-Fun Maa*
  1. Pharmaceutical Processing and Technology Development, Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080
  1. ↵* Corresponding Author: Genentech, Inc., a Member of the Roche Group, 1 DNA Way South San Francisco, CA 94080; E-mail: maay{at}gene.com. Telephone: +1-650-225-3499; Fax: +1-650-742-1504
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PDA Journal of Pharmaceutical Science and Technology: 73 (5)
PDA Journal of Pharmaceutical Science and Technology
Vol. 73, Issue 5
September/October 2019
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Vapor-Phase Hydrogen Peroxide Uptake by Silicone Tubing and Primary Packaging Components during Protein Drug Product Aseptic Filling: Impact of Pretreatment and Sterilization Process
Devon Roshan Eisner, Aaron Hubbard, Kirk Eppler, Vassia Tegoulia, Yuh-Fun Maa
PDA Journal of Pharmaceutical Science and Technology Sep 2019, 73 (5) 443-458; DOI: 10.5731/pdajpst.2019.009928

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Vapor-Phase Hydrogen Peroxide Uptake by Silicone Tubing and Primary Packaging Components during Protein Drug Product Aseptic Filling: Impact of Pretreatment and Sterilization Process
Devon Roshan Eisner, Aaron Hubbard, Kirk Eppler, Vassia Tegoulia, Yuh-Fun Maa
PDA Journal of Pharmaceutical Science and Technology Sep 2019, 73 (5) 443-458; DOI: 10.5731/pdajpst.2019.009928
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Keywords

  • Vapor-phase hydrogen peroxide
  • Monoclonal antibody
  • VPHP uptake
  • Primary packaging components
  • Silicone tubing
  • Sterilization
  • Gamma irradiation
  • Autoclave
  • VHP
  • Vaporized hydrogen peroxide

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