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

Adventitious Viruses Detected in Biopharmaceutical Bulk Harvest Samples over a 10 Year Period

Andrew Kerr and Raymond Nims
PDA Journal of Pharmaceutical Science and Technology September 2010, 64 (5) 481-485;
Andrew Kerr
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Raymond Nims
  • 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

References

  1. 1.↵
    1. Nims R.
    Detection of adventitious viruses in biologicals—A rare occurrence. Dev. Biol. (Basel) 2006, 123, 153–164.
    OpenUrlPubMed
  2. 2.↵
    Genzyme press release, 2009, http://www.genzyme.com/corp/media/GENZ%20PR-061609.asp.
  3. 3.↵
    1. Oehmig A.,
    2. Büttner M.,
    3. Weiland F.,
    4. Werz W.,
    5. Bergemann K,
    6. Pfaff E.
    Identification of a calicivirus isolate of unknown origin. J. Gen. Virol. 2003, 84 (10), 2837–2845.
    OpenUrlAbstract/FREE Full Text
  4. 4.↵
    US FDA Points to Consider in the Characterization of Cell Lines Used to Produce Biologics, FDA/CDER. 1993.
  5. 5.↵
    International Conference on Harmonisation ICH Q5A (R1). Quality of Biotechnological Products: Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin. CPMP/ICH/295/95. October 1997.
  6. 6.↵
    1. Shepherd A. J.,
    2. Wilson N. J.,
    3. Smith K. T.
    Characterization of endogenous retrovirus in rodent cell lines used for production of biologicals. Biologicals 2003, 31 (4), 251–260.
    OpenUrlCrossRefPubMed
  7. 7.↵
    1. Spier R. E.
    1. Wiebe M. E.,
    2. Becker F.,
    3. Lazar R.,
    4. May L.,
    5. Casto B.,
    6. Semense M.,
    7. Fautz C.,
    8. Garnick R.,
    9. Miller C.,
    10. Masover G.,
    11. Bergmann D.,
    12. Lubiniecki A. S.
    A Multifaceted Approach To Assure That Recombinant tPA Is Free of Adventitious Virus. In Advances in Animal Cell Biology and Technology for Bioprocesses; Spier R. E., Ed.; Butterworths: London, 1989; pp 68–71.
  8. 8.↵
    1. Poiley J. A.,
    2. Nelson R. E.,
    3. Hillesund T.,
    4. Raineri R.
    Susceptibility of CHO-K1 cells to infection by eight adventitious viruses and four retroviruses. In Vitro Toxicol. 1991, 4 (1), 1–12.
    OpenUrl
  9. 9.↵
    1. Garnick R. L.
    Experience with viral contamination in cell culture. Dev. Biol. Stand. 1996, 88, 49–56.
    OpenUrlPubMed
  10. 10.↵
    US FDA Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use. FDA/CDER 1997.
  11. 11.↵
    1. Boose J. A.,
    2. Lister D. C.,
    3. Sofer G.
    Virus inactivation in the 1990s—and into the 21st Century. Part 6, Inactivation methods grouped by virus. Biopharm Int. 2003, 16 (4), 42–52, 68.
    OpenUrl
  12. 12.↵
    1. Weaver B.
    Evaluation of UVC and HTST media treatment for viral risk mitigation in mammalian cell culture processes. PDA Cell Substrates Workshop, Bethesda, MD, 2009. http://www.pda.org/Presentation/PDA-Cell-Substrate-Workshop/Robert-Weaver.aspx.
  13. 13.↵
    1. Schleh M.,
    2. Romanowski P.,
    3. Bhebe P.,
    4. Zhang L.,
    5. Chinniah S.,
    6. Lawrence B.,
    7. Bashiri H.,
    8. Gaduh A.,
    9. Rajurs V.,
    10. Rasmussen B.,
    11. Chuck A.,
    12. Dehghani H.
    Susceptibility of mouse minute virus to inactivation by heat in two cell culture media types. Biotechnol. Prog. 2009, 25 (3), 854–860.
    OpenUrlPubMed
  14. 14.↵
    1. Rathore A.,
    2. S.,
    3. Sofer G.
    1. Nims R.,
    2. Presente E.,
    3. Sofer G.,
    4. Phillips C.,
    5. Chang A.
    Adventitious Agents: Concerns and Testing for Biopharmaceuticals. In Process Validation in Manufacturing of Biopharmaceuticals: Guidelines, Current Practices, and Industrial Case Studies; Rathore A., S., Sofer G., Eds.; CRC Press/Francis Informa: Boca Raton, FL, 2005; pp 143–167.
  15. 15.↵
    1. Nims R. W.,
    2. Dusing SK.,
    3. Hsieh W.-T.,
    4. Lovatt A.,
    5. Reid G. G.,
    6. Onions D.,
    7. Milne E. W.
    Detection of Cache Valley virus in biologics manufactured in CHO cells. BioPharm Int. 2008, 21 (10), 89–94.
    OpenUrl
  16. 16.↵
    Code of Federal Regulations: Animals and Animal Products. Title 9, Part 113.53. US Government Printing Office: Washington, DC, 2003.
  17. 17.↵
    1. Kurth J.,
    2. Waldmann R.,
    3. Heith J.,
    4. Mausbach K.,
    5. Burian R.
    Efficient inactivation of viruses and mycoplasma in animal sera using UVC irradiation. Dev. Biol. Stand. 1999, 99, 111–118.
    OpenUrlPubMed
  18. 18.↵
    1. Gauvin G.,
    2. Nims R
    . Gamma-irradiation of serum for the inactivation of adventitious contaminants. PDA J. Pharm. Sci. Technol. 2010 (this volume).
PreviousNext
Back to top

In This Issue

PDA Journal of Pharmaceutical Science and Technology: 64 (5)
PDA Journal of Pharmaceutical Science and Technology
Vol. 64, Issue 5
September/October 2010
  • 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.
Adventitious Viruses Detected in Biopharmaceutical Bulk Harvest Samples over a 10 Year Period
(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 + 1 =
Solve this simple math problem and enter the result. E.g. for 1+3, enter 4.
Citation Tools
Adventitious Viruses Detected in Biopharmaceutical Bulk Harvest Samples over a 10 Year Period
Andrew Kerr, Raymond Nims
PDA Journal of Pharmaceutical Science and Technology Sep 2010, 64 (5) 481-485;

Citation Manager Formats

  • BibTeX
  • Bookends
  • EasyBib
  • EndNote (tagged)
  • EndNote 8 (xml)
  • Medlars
  • Mendeley
  • Papers
  • RefWorks Tagged
  • Ref Manager
  • RIS
  • Zotero
Share
Adventitious Viruses Detected in Biopharmaceutical Bulk Harvest Samples over a 10 Year Period
Andrew Kerr, Raymond Nims
PDA Journal of Pharmaceutical Science and Technology Sep 2010, 64 (5) 481-485;
Twitter logo Facebook logo Mendeley logo
  • Tweet Widget
  • Facebook Like
  • Google Plus One

Jump to section

  • Article
    • Abstract
    • Introduction
    • Detection Experience at BioReliance
    • Summary
    • References
  • Figures & Data
  • References
  • Info & Metrics
  • PDF

Related Articles

  • No related articles found.
  • PubMed
  • Google Scholar

Cited By...

  • Identification and Root Cause Analysis of Cell Culture Media Precipitates in the Viral Deactivation Treatment with High-Temperature/Short-Time Method
  • Google Scholar

More in this TOC Section

Conference Proceeding

  • Proceedings of the 2017 Viral Clearance Symposium, Session 3: Resin Lifetime
  • Proceedings of the 2017 Viral Clearance Symposium, Session 1.1: Upstream Mitigation, Part 1—Cell Bank and Bulk Harvest Testing
  • Proceedings of the 2017 Viral Clearance Symposium, Session 6: Ensuring Viral Safety in Continuous Processing
Show more Conference Proceeding

Virus Testing

  • Rapid Molecular Assays for Microbial Contaminant Monitoring in the Bioprocess Industry
  • Root Cause Investigation of Unusual Results Experienced during Master Cell Bank (MCB) Testing and Characterization
  • Apparent Virus Contamination in Biopharmaceutical Product at Centocor
Show more Virus Testing

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