Skip to main content
  • Main menu
  • User menu
  • Search

Main menu

  • Home
  • Content
    • Current Issue
    • Past Issues
    • Accepted Articles
    • Email Alerts
    • RSS
    • Terms of Use
  • About PDA JPST
    • JPST Editors and Editorial Board
    • About/Vision/Mission
    • Paper of the Year
  • Author & Reviewer Resources
    • Author Resources / Submit
    • Reviewer Resources
  • JPST Access and Subscriptions
    • PDA Members
    • Institutional Subscriptions
    • Nonmember Access
  • Support
    • Join PDA
    • Contact
    • Feedback
    • Advertising
    • CiteTrack
  • .
    • Visit PDA
    • PDA Letter
    • Technical Reports
    • news uPDATe
    • Bookstore

User menu

  • Register
  • Subscribe
  • My alerts
  • Log in
  • My Cart

Search

  • Advanced search
PDA Journal of Pharmaceutical Science and Technology
  • .
    • Visit PDA
    • PDA Letter
    • Technical Reports
    • news uPDATe
    • Bookstore
  • Register
  • Subscribe
  • My alerts
  • Log in
  • My Cart
PDA Journal of Pharmaceutical Science and Technology

Advanced Search

  • Home
  • Content
    • Current Issue
    • Past Issues
    • Accepted Articles
    • Email Alerts
    • RSS
    • Terms of Use
  • About PDA JPST
    • JPST Editors and Editorial Board
    • About/Vision/Mission
    • Paper of the Year
  • Author & Reviewer Resources
    • Author Resources / Submit
    • Reviewer Resources
  • JPST Access and Subscriptions
    • PDA Members
    • Institutional Subscriptions
    • Nonmember Access
  • Support
    • Join PDA
    • Contact
    • Feedback
    • Advertising
    • CiteTrack
  • Follow pda on Twitter
  • Visit PDA on LinkedIn
  • Visit pda on Facebook
Case ReportCase Studies

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

Devon Roshan Eisner, Ada Hui, Kirk Eppler, Vassia Tegoulia and Yuh-Fun Maa
PDA Journal of Pharmaceutical Science and Technology May 2019, 73 (3) 285-291; DOI: https://doi.org/10.5731/pdajpst.2018.009340
Devon Roshan Eisner
1Pharmaceutical Processing and Technology Development, Genentech, a Member of the Roche Group, 1 DNA Way South San Francisco, CA 94080; and
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Ada Hui
2Late Stage Pharmaceutical Development, Genentech, a Member of the Roche Group, 1 DNA Way, South San Francisco, CA 94080
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Kirk Eppler
1Pharmaceutical Processing and Technology Development, Genentech, a Member of the Roche Group, 1 DNA Way South San Francisco, CA 94080; and
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Vassia Tegoulia
1Pharmaceutical Processing and Technology Development, Genentech, a Member of the Roche Group, 1 DNA Way South San Francisco, CA 94080; and
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Yuh-Fun Maa
1Pharmaceutical Processing and Technology Development, Genentech, a Member of the Roche Group, 1 DNA Way South San Francisco, CA 94080; and
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • For correspondence: maay@gene.com
  • Article
  • Figures & Data
  • References
  • Info & Metrics
  • PDF
Loading

Article Information

vol. 73 no. 3 285-291
DOI 
https://doi.org/10.5731/pdajpst.2018.009340
PubMed 
30651338

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online May 31, 2019.

Article Versions

  • previous version (January 16, 2019 - 07:46).
  • You are viewing the most recent version of this article.
Copyright & Usage 
© PDA, Inc. 2019

Author Information

  1. Devon Roshan Eisner1,
  2. Ada Hui2,
  3. Kirk Eppler1,
  4. Vassia Tegoulia1 and
  5. Yuh-Fun Maa1,*
  1. 1Pharmaceutical Processing and Technology Development, Genentech, a Member of the Roche Group, 1 DNA Way South San Francisco, CA 94080; and
  2. 2Late Stage Pharmaceutical Development, Genentech, a Member of the Roche Group, 1 DNA Way, South San Francisco, CA 94080
  1. ↵* Corresponding Author: Genentech, a Member of the Roche Group, 1 DNA Way, South San Francisco, CA 94080. Telephone: +1-650-225-3499; Fax: +1-650-742-1504; e-mail: maay@gene.com
View Full Text

Cited By...

  • 8 Citations
  • Google Scholar

This article has been cited by the following articles in journals that are participating in Crossref Cited-by Linking.

  • A Reactive Oxygen Species-Scavenging ‘Stealth’ Polymer, Poly(thioglycidyl glycerol), Outperforms Poly(ethylene glycol) in Protein Conjugates and Nanocarriers and Enhances Protein Stability to Environmental and Biological Stressors
    Richard d’Arcy, Farah El Mohtadi, Nora Francini, Carlisle R. DeJulius, Hyunmoon Back, Arianna Gennari, Mike Geven, Maria Lopez-Cavestany, Zulfiye Yesim Turhan, Fang Yu, Jong Bong Lee, Michael R. King, Leonid Kagan, Craig L. Duvall, Nicola Tirelli
    Journal of the American Chemical Society 2022 144 46
  • Stress Factors in Protein Drug Product Manufacturing and Their Impact on Product Quality
    Tapan K. Das, Alavattam Sreedhara, James D. Colandene, Danny K. Chou, Vasco Filipe, Christoph Grapentin, Jim Searles, Twinkle R. Christian, Linda O. Narhi, Wim Jiskoot
    Journal of Pharmaceutical Sciences 2022 111 4
  • Container Closure and Delivery Considerations for Intravitreal Drug Administration
    Ashwin C. Parenky, Saurabh Wadhwa, Hunter H. Chen, Amardeep S. Bhalla, Kenneth S. Graham, Mohammed Shameem
    AAPS PharmSciTech 2021 22 3
  • Bactericidal efficacy of a low concentration of vaporized hydrogen peroxide with validation in a BSL-3 laboratory
    C. Tao, G. Sun, X. Tang, Y. Gan, G. Liang, J. Wang, Y. Huang
    Journal of Hospital Infection 2022 127
  • Impact of H2O2 Sorption by Polymers on the Duration of Aeration in Pharmaceutical Decontamination
    Keisho Yabuta, Haruka Futamura, Koji Kawasaki, Hirokazu Sugiyama
    Journal of Pharmaceutical Sciences 2020 109 9
  • Vaporized Hydrogen Peroxide Sterilization in the Production of Protein Therapeutics: Uptake and Effects on Product Quality
    Michael Meleties, Bailey M. Cooper, Daniela Marcano-James, Amardeep S. Bhalla, Mohammed Shameem
    Journal of Pharmaceutical Sciences 2023 112 12
  • Filling Unit Operation for Biological Drug Products: Challenges and Considerations
    Michael Adler, Andrea Allmendinger
    Journal of Pharmaceutical Sciences 2024 113 2
  • Stability evaluation from hydrogen peroxide spiking studies
    Alexandra H. Heussner, Marlene Hermann, Melanie Zerulla-Wernitz
    European Journal of Pharmaceutical Sciences 2024 203
PreviousNext
Back to top

In This Issue

PDA Journal of Pharmaceutical Science and Technology: 73 (3)
PDA Journal of Pharmaceutical Science and Technology
Vol. 73, Issue 3
May/June 2019
  • Table of Contents
  • Index by Author
Print
Download PDF
Article Alerts
Email Article
Citation Tools
Share
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
Devon Roshan Eisner, Ada Hui, Kirk Eppler, Vassia Tegoulia, Yuh-Fun Maa
PDA Journal of Pharmaceutical Science and Technology May 2019, 73 (3) 285-291; DOI: 10.5731/pdajpst.2018.009340
Twitter logo Facebook logo Mendeley logo
  • Tweet Widget

Jump to section

  • Article
    • Abstract
    • 1. Introduction
    • 2. Materials and Methods
    • 3. Results and Discussion
    • 4. Conclusions
    • Conflict of Interest Declaration
    • Acknowledgments
    • References
  • Figures & Data
  • References
  • Info & Metrics
  • PDF

Related Articles

  • No related articles found.
  • PubMed
  • Google Scholar

Cited By...

  • Development and Validation of a Customized Amplex UltraRed Assay for Sensitive Hydrogen Peroxide Detection in Pharmaceutical Water
  • Google Scholar

More in this TOC Section

  • Phase-Incremental Decision Trees for Multi-Phase Feature Selection and Interaction in Biologics Manufacturing
  • Practical Application of Setting up an Annual Contamination Control Strategy (CCS) Assessment
  • A Case Study in Application of the Risk Knowledge Infinity Cycle
Show more Case Studies

Similar Articles

Keywords

  • Hydrogen peroxide (H2O2)
  • Vapor phase hydrogen peroxide (VPHP)
  • Vaporized hydrogen peroxide (VHP)
  • monoclonal antibody
  • VPHP uptake
  • H2O2 decomposition

Readers

  • About
  • Table of Content Alerts/Other Alerts
  • Subscriptions
  • Terms of Use
  • Contact Editors

Author/Reviewer Information

  • Author Resources
  • Submit Manuscript
  • Reviewers
  • Contact Editors

Parenteral Drug Association, Inc.

  • About
  • Advertising/Sponsorships
  • Events
  • PDA Bookstore
  • Press Releases

© 2025 PDA Journal of Pharmaceutical Science and Technology Print ISSN: 1079-7440  Digital ISSN: 1948-2124

Powered by HighWire
Alerts for this Article
Sign In to Email Alerts with your Email Address
Email this Article

Thank you for your interest in spreading the word on PDA Journal of Pharmaceutical Science and Technology.

NOTE: We only request your email address so that the person you are recommending the page to knows that you wanted them to see it, and that it is not junk mail. We do not capture any email address.

Enter multiple addresses on separate lines or separate them with commas.
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
(Your Name) has sent you a message from PDA Journal of Pharmaceutical Science and Technology
(Your Name) thought you would like to see the PDA Journal of Pharmaceutical Science and Technology web site.
CAPTCHA
This question is for testing whether or not you are a human visitor and to prevent automated spam submissions.
1 + 0 =
Solve this simple math problem and enter the result. E.g. for 1+3, enter 4.
Citation Tools
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
Devon Roshan Eisner, Ada Hui, Kirk Eppler, Vassia Tegoulia, Yuh-Fun Maa
PDA Journal of Pharmaceutical Science and Technology May 2019, 73 (3) 285-291; DOI: 10.5731/pdajpst.2018.009340

Citation Manager Formats

  • BibTeX
  • Bookends
  • EasyBib
  • EndNote (tagged)
  • EndNote 8 (xml)
  • Medlars
  • Mendeley
  • Papers
  • RefWorks Tagged
  • Ref Manager
  • RIS
  • Zotero

We use cookies on this site to enhance your user experience

By clicking any link on this page you are giving your consent for us to set cookies.