Skip to main content

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
Research ArticleConference Proceeding - Article

Viral Clearance Using Traditional, Well-Understood Unit Operations (Session I): Virus-Retentive Filtration

Dayue Chen
PDA Journal of Pharmaceutical Science and Technology January 2014, 68 (1) 38-50; DOI: https://doi.org/10.5731/pdajpst.2014.00965
Dayue Chen
Eli Lilly and Company, Indianapolis, IN
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • Article
  • Figures & Data
  • References
  • Info & Metrics
  • PDF
Loading

Article Information

vol. 68 no. 1 38-50
DOI 
https://doi.org/10.5731/pdajpst.2014.00965
PubMed 
24504235

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online February 6, 2014.

Copyright & Usage 
© PDA, Inc. 2014

Author Information

Cited By...

  • 14 Citations
  • Google Scholar

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

  • Stress Factors in mAb Drug Substance Production Processes: Critical Assessment of Impact on Product Quality and Control Strategy
    Tapan K. Das, Linda O. Narhi, Alavattam Sreedhara, Tim Menzen, Christoph Grapentin, Danny K. Chou, Valentyn Antochshuk, Vasco Filipe
    Journal of Pharmaceutical Sciences 2020 109 1
  • Characterizing the impact of pressure on virus filtration processes and establishing design spaces to ensure effective parvovirus removal
    Daniel Strauss, Joshua Goldstein, Tomoko Hongo‐Hirasaki, Yoshiro Yokoyama, Naokatsu Hirotomi, Tomoyuki Miyabayashi, Dominick Vacante
    Biotechnology Progress 2017 33 5
  • Mechanistic failure mode investigation and resolution of parvovirus retentive filters
    Daniel LaCasse, Scott Lute, Marcus Fiadeiro, Jonida Basha, Matthew Stork, Kurt Brorson, Ranga Godavarti, Chris Gallo
    Biotechnology Progress 2016 32 4
  • Significance of Brownian Motion for Nanoparticle and Virus Capture in Nanocellulose-Based Filter Paper
    Olof Gustafsson, Simon Gustafsson, Levon Manukyan, Albert Mihranyan
    Membranes 2018 8 4
  • Virus filtration: A review of current and future practices in bioprocessing
    Sarah A. Johnson, Shuang Chen, Glen Bolton, Qi Chen, Scott Lute, John Fisher, Kurt Brorson
    Biotechnology and Bioengineering 2022 119 3
  • Characterization of operating parameters for XMuLV inactivation by low pH treatment
    Shivanthi Chinniah, Peter Hinckley, Lisa Connell-Crowley
    Biotechnology Progress 2016 32 1
  • Growth media filtration using nanocellulose-based virus removal filter for upstream biopharmaceutical processing
    Levon Manukyan, Pengfei Li, Simon Gustafsson, Albert Mihranyan
    Journal of Membrane Science 2019 572
  • An updated analysis of viral clearance unit operations for biotechnology manufacturing
    Opeyemi O. Ajayi, Sarah A. Johnson, Talia Faison, Nicole Azer, Jackie L. Cullinan, Jessica Dement-Brown, Scott C. Lute
    Current Research in Biotechnology 2022 4
  • Prediction of viral filtration performance of monoclonal antibodies based on biophysical properties of feed
    William J. Rayfield, David J. Roush, Rebecca A. Chmielowski, Nihal Tugcu, Shehab Barakat, Jason K. Cheung
    Biotechnology Progress 2015 31 3
  • Comparative Analysis of Dry and Wet Porometry Methods for Characterization of Regular and Cross-Linked Virus Removal Filter Papers
    Simon Gustafsson, Frank Westermann, Tobias Hanrieder, Laura Jung, Horst Ruppach, Albert Mihranyan
    Membranes 2018 9 1
  • Application of Formulation Principles to Stability Issues Encountered During Processing, Manufacturing, and Storage of Drug Substance and Drug Product Protein Therapeutics
    Samadhi Vitharana, Joshua M. Stillahn, Derrick S. Katayama, Charles S. Henry, Mark Cornell Manning
    Journal of Pharmaceutical Sciences 2023 112 11
  • Evaluation of the Virus Elimination and Inactivation at Different Stages of the Model Biotechnological Process for the Production of a Drug Based on the Monoclonal Antibody Fab-Fragment
    R.A. Vassarays, S.G. Yurkov, S.P Zhivoderov, A.Y. Koltsov, R.A. Khamitov, N.V. Stratonova, N.A. Litvinova
    Biotekhnologiya 2021 37 1
  • Single‐Use Technology in Biopharmaceutical Manufacture
    Christian Julien, Chuck Capron
    2019
  • Viral clearance capability of monoclonal antibody purification
    Kang Cai, Jennifer Anderson, Etienne Utiger, Gisela Ferreira
    Biologicals 2024 85
PreviousNext
Back to top

In This Issue

PDA Journal of Pharmaceutical Science and Technology: 68 (1)
PDA Journal of Pharmaceutical Science and Technology
Vol. 68, Issue 1
January/February 2014
  • Table of Contents
  • Index by Author
Print
Download PDF
Article Alerts
Sign In to Email Alerts with your Email Address
Email 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.
Viral Clearance Using Traditional, Well-Understood Unit Operations (Session I): Virus-Retentive Filtration
(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.
3 + 0 =
Solve this simple math problem and enter the result. E.g. for 1+3, enter 4.
Citation Tools
Viral Clearance Using Traditional, Well-Understood Unit Operations (Session I): Virus-Retentive Filtration
Dayue Chen
PDA Journal of Pharmaceutical Science and Technology Jan 2014, 68 (1) 38-50; DOI: 10.5731/pdajpst.2014.00965

Citation Manager Formats

  • BibTeX
  • Bookends
  • EasyBib
  • EndNote (tagged)
  • EndNote 8 (xml)
  • Medlars
  • Mendeley
  • Papers
  • RefWorks Tagged
  • Ref Manager
  • RIS
  • Zotero
Share
Viral Clearance Using Traditional, Well-Understood Unit Operations (Session I): Virus-Retentive Filtration
Dayue Chen
PDA Journal of Pharmaceutical Science and Technology Jan 2014, 68 (1) 38-50; DOI: 10.5731/pdajpst.2014.00965
Twitter logo Facebook logo Mendeley logo
  • Tweet Widget
  • Facebook Like
  • Google Plus One

Jump to section

  • Article
    • Background
    • Generic Validation
    • Characterization of the Virus-Retentive Filtration Unit Operation
    • Generic Validation with a Single Model Virus (Eva Gefroh, Amgen)
    • Virus-Retentive Filtration, Genentech Experience (Rachel Specht, Aimee Durbin; Genentech, a Member of the Roche Group)
    • Defining Robust Operating Ranges for Virus-Retentive Filtration in a mAb Platform Process for Reproducible Viral Clearance (Hong Shen, Dominick Vacante, and Pedro Alfonso; Active Pharmaceutical Ingredient - Large Molecule, Janssen Pharmaceuticals, Johnson & Johnson)
    • Evaluation of a 20 nm Hollow-Fiber Filter for Parvovirus Clearance (Adith Venkiteshwaran, J. Nolting, and Dayue Chen; Eli Lilly and Company)
    • Parvovirus Filter Protection via CEX Guard Columns (J. Bill Jr.; Genentech, a Member of the Roche Group)
    • Systematic Approach for Characterization of the Virus-Retentive Filtration Unit Operation: Additional Knowledge or Extra Frustration? (D. Chen, A. Venkiteshwaran, and D. Strauss; Eli Lilly and Company)
    • Summary
    • References
  • Figures & Data
  • References
  • Info & Metrics
  • PDF

Related Articles

  • No related articles found.
  • PubMed
  • Google Scholar

Cited By...

  • Using Sensitivity Analysis to Simplify the Virus Safety Factor Calculation in the Manufacture of Biopharmaceuticals
  • Viral Clearance Using Traditional, Well-Understood Unit Operations Session 1.2: Virus-Retentive Filtration
  • Viral Clearance of Traditional Unit Operations: Virus-Retentive Filtration
  • Google Scholar

More in this TOC Section

  • Emerging Unit Operations (Session III): Hydroxyapatite, Mixed-Mode, and Adsorptive Membrane Chromatography; UV-C Inactivation; Chemical Precipitation
  • Viral Clearance Integration (Session IV): General Trends, Bracketing, QbD, Virus Preparation Quality Attributes
Show more Conference Proceeding - Article

Similar Articles

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