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 ArticleProceedings of the 2017 Viral Clearance Symposium

Proceedings of the 2017 Viral Clearance Symposium, Session 4: Submission Strategies

Astrid Schwantes, Rachel Specht and Qi Chen
PDA Journal of Pharmaceutical Science and Technology September 2018, 72 (5) 498-510; DOI: https://doi.org/10.5731/pdajpst.2018.009142
Astrid Schwantes
1Virology Department, Paul-Ehrlich-Institut, Paul-Ehrlich-Strasse 51-59, 63225 Langen, Germany; and
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • For correspondence: Astrid.Schwantes@pei.de
Rachel Specht
2Process Virology, Genentech, 1 DNA Way South San Francisco, CA 94080, USA
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Qi Chen
2Process Virology, Genentech, 1 DNA Way South San Francisco, CA 94080, USA
  • 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. 72 no. 5 498-510
DOI 
https://doi.org/10.5731/pdajpst.2018.009142
PubMed 
30030357

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online October 6, 2018.

Article Versions

  • previous version (July 20, 2018 - 14:19).
  • You are viewing the most recent version of this article.
Copyright & Usage 
© PDA, Inc. 2018

Author Information

  1. Astrid Schwantes1,*,
  2. Rachel Specht2 and
  3. Qi Chen2
  1. 1Virology Department, Paul-Ehrlich-Institut, Paul-Ehrlich-Strasse 51-59, 63225 Langen, Germany; and
  2. 2Process Virology, Genentech, 1 DNA Way South San Francisco, CA 94080, USA
  1. ↵* Corresponding Author: Virology Department, Paul-Ehrlich-Institut, Paul-Ehrlich-Strasse 51-59, 63225 Langen, Germany; e-mail: Astrid.Schwantes{at}pei.de
View Full Text

Cited By...

  • 6 Citations
  • Google Scholar

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

  • Application of machine learning methods to pathogen safety evaluation in biological manufacturing processes
    Shyam Panjwani, Ivan Cui, Konstantinos Spetsieris, Michal Mleczko, Wensheng Wang, June X. Zou, Mohammad Anwaruzzaman, Shawn Liu, Roger Canales, Oliver Hesse
    Biotechnology Progress 2021 37 3
  • Surrogate model to screen for inactivation‐based clearance of enveloped viruses during biotherapeutics process development
    Hasin Feroz, Daniel Cetnar, Robert Hewlett, Satish Sharma, Melissa Holstein, Sanchayita Ghose, Zheng Jian Li
    Biotechnology Journal 2021 16 12
  • Suitability of a generic virus safety evaluation for monoclonal antibody investigational new drug applications
    Patrick Sipple, Tung Nguyen, Krina Patel, Neil Jaffe, Yan Chen, Anurag Khetan
    Biotechnology Progress 2019 35 5
  • Effects of the COVID-19 pandemic: new approaches for accelerated delivery of gene to first-in-human CMC data for recombinant proteins
    Hervé Broly, Jonathan Souquet, Alain Beck
    mAbs 2023 15 1
  • Removal of minute virus of mice-mock virus particles by nanofiltration of culture growth medium supplemented with 10% human platelet lysate
    Lassina Barro, Liling Delila, Ouada Nebie, Yu-Wen Wu, Folke Knutson, Naoto Watanabe, Masayasu Takahara, Thierry Burnouf
    Cytotherapy 2021 23 10
  • A direct RT qPCR method for quantification of retrovirus-like particles in biopharmaceutical production with CHO cells
    Musaddeq Hussain, William J. Rayfield, David J. Roush
    Journal of Pharmaceutical and Biomedical Analysis 2020 189
PreviousNext
Back to top

In This Issue

PDA Journal of Pharmaceutical Science and Technology: 72 (5)
PDA Journal of Pharmaceutical Science and Technology
Vol. 72, Issue 5
September/October 2018
  • 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.
Proceedings of the 2017 Viral Clearance Symposium, Session 4: Submission Strategies
(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.
16 + 1 =
Solve this simple math problem and enter the result. E.g. for 1+3, enter 4.
Citation Tools
Proceedings of the 2017 Viral Clearance Symposium, Session 4: Submission Strategies
Astrid Schwantes, Rachel Specht, Qi Chen
PDA Journal of Pharmaceutical Science and Technology Sep 2018, 72 (5) 498-510; DOI: 10.5731/pdajpst.2018.009142

Citation Manager Formats

  • BibTeX
  • Bookends
  • EasyBib
  • EndNote (tagged)
  • EndNote 8 (xml)
  • Medlars
  • Mendeley
  • Papers
  • RefWorks Tagged
  • Ref Manager
  • RIS
  • Zotero
Share
Proceedings of the 2017 Viral Clearance Symposium, Session 4: Submission Strategies
Astrid Schwantes, Rachel Specht, Qi Chen
PDA Journal of Pharmaceutical Science and Technology Sep 2018, 72 (5) 498-510; DOI: 10.5731/pdajpst.2018.009142
Twitter logo Facebook logo Mendeley logo
  • Tweet Widget
  • Facebook Like
  • Google Plus One

Jump to section

  • Article
    • Abstract
    • Background and Session Overview
    • Retrovirus Clearance Risk Evaluation and Clearance Target for Chinese Hamster Ovary Cells
    • Bin Yang, Genentech
    • A Proposal for Future BLA Submissions on Virus Filtration: Parvovirus Removal Studies Only
    • Rachel Specht and Qi Chen, Genentech
    • qPCR as an Alternative to TEM and Infectivity Assays
    • William Rayfield, Merck
    • The Use of RVLP in Research and Development Viral Clearance Studies
    • Moritz Bennecke, Roche Pharma
    • Getting Medicines to Patients Fast
    • Sherrie Curtis, Genetech
    • Streamlining Virus Clearance (VC) Studies to Reduce Costs and Time to Clinic
    • Lisa Connell-Crowley, Just Biotherapeutics
    • Viral Clearance Strategy for Early-Phase Program
    • Mi Jin, Teva Pharmaceuticals
    • ASTM Update on Standards for Low pH Inactivation and Virus Retentive Filtration
    • John Schreffler, Janssen J&J
    • Summary
    • Conflict of Interest Declaration
    • Reference
  • Figures & Data
  • References
  • Info & Metrics
  • PDF

Related Articles

  • No related articles found.
  • PubMed
  • Google Scholar

Cited By...

  • Proceedings of the 2019 Viral Clearance Symposium, Session 4: Viral Clearance Strategy and Process Understanding
  • Proceedings of the 2019 Viral Clearance Symposium, Session 1: Viral Clearance Strategies and Case Studies
  • Google Scholar

More in this TOC Section

Proceedings of the 2017 Viral Clearance Symposium

  • Proceedings of the 2017 Viral Clearance Symposium, Session 2.1: DSP Unit Operations—Virus Filtration/Inactivation
  • Proceedings of the 2017 Viral Clearance Symposium, Session 2.2: DSP Unit Operations–Purification Unit Operations
  • Proceedings of the 2017 Viral Clearance Symposium—
Show more Proceedings of the 2017 Viral Clearance Symposium

Conference Proceeding

  • Proceedings of the 2017 Viral Clearance Symposium: Conclusion
  • Proceedings of the 2017 Viral Clearance Symposium, Session 1.2: Upstream Mitigation, Part 2—Virus Barrier Filter and HTST
  • Proceedings of the 2017 Viral Clearance Symposium, Session 3: Resin Lifetime
Show more Conference Proceeding

Similar Articles

Keywords

  • Viral clearance
  • Project acceleration
  • Novel format molecules
  • Retrovirus-like particle
  • Quantitative polymerase chain reaction
  • Safety margin

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