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 ArticleResearch

Establishing Acceptable Limits of Residual DNA

Harry Yang
PDA Journal of Pharmaceutical Science and Technology March 2013, 67 (2) 155-163; DOI: https://doi.org/10.5731/pdajpst.2013.00910
Harry Yang
MedImmune LLC, Gaithersburg, MD
  • 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. Lewis A. M. Jr..,
    2. Krause P.,
    3. Peden K.
    A defined-risks approach to the regulatory assessment of the use of neoplastic cells as substrates for viral vaccine manufacture. Dev. Biol. (Basel) 2001, 106, 513–35.
    OpenUrlPubMed
  2. 2.↵
    1. Petricciani J. C.,
    2. Regan P. J.
    Risk of neoplastic transformation from cellular DNA: calculations using the oncogene model. Dev. Biol. Stand. 1987, 68, 43–49.
    OpenUrlPubMed
  3. 3.↵
    1. Petricianni J. C.,
    2. Horaud F. N.
    DNA, dragons and sanity: residual cellular DNA in biotechnological products. Biologicals 1995, 23 (3), 233–238.
    OpenUrlPubMed
  4. 4.↵
    1. Petricciani J.,
    2. Loewer J.
    An overview of cell DNA issues. Dev. Biol. (Basel) 2001, 106, 275–782, discussion 317–329.
    OpenUrlPubMed
  5. 5.↵
    1. Sheng L.,
    2. Cai F.,
    3. Zhu Y.,
    4. Pal A.,
    5. Athanasiou M.,
    6. Orrison B.,
    7. Blair D. G.,
    8. Hughes S. H.,
    9. Coffin J. M.,
    10. Lewis A. M.,
    11. Peden K.
    Oncogenicity of DNA in vivo: tumor induction with expression plasmids for activated H-ras and c-myc. Biologicals 2008, 36 (3), 184–197.
    OpenUrlPubMed
  6. 6.↵
    1. Peden K.,
    2. Sheng L.,
    3. Pal A.,
    4. Lewis A.
    Biological activity of residual cell substrate DNA. Dev. Biol. (Basel) 2006, 123, 45–56, discussion 55–73.
    OpenUrlPubMed
  7. 7.↵
    1. Hopps H. E.,
    2. Petricciani J. C.
    In Vitro Cellular and Development Biology. Monograph No. 6: Abnormal Cells, New Products, and Risks; Hopps H. E., Petricciani J. C., Eds.; Tissue Culture Association: Gaithersburg, MD, 1985.
  8. 8.↵
    1. Temin H. M.
    Overview of biological effects of addition of DNA molecules to cells. J. Med. Virol. 1990, 31 (1), 13–17.
    OpenUrlPubMed
  9. 9.↵
    WHO (World Health Organization) Meeting Report Study group on cell substrates for production of biologicals. June 11 and 12, 2007; 1–30.
  10. 10.↵
    FDA Guidance for Industry: Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indications. U.S. Department of Health and Human Services, Food and Drug Administration Center for Biologics Evaluation and Research, February, 2010.
  11. 11.↵
    U.S. FDA. Pharamaceutical cGMPs for the 21st Century: A Risk-Based Approach: Final Report, 2004.
  12. 12.↵
    ICH Q8: Pharmaceutical Development, 2006.
  13. 13.↵
    1. Yang H.,
    2. Zhang L.,
    3. Galinski M.
    A probabilistic model for risk assessment of residual host cell DNA in biological products. Vaccine, 2010, 28 (19), 3308–3311.
    OpenUrlPubMed
  14. 14.↵
    1. Krause P. R.,
    2. Lewis A. M. Jr..
    Safety of viral DNA in biological products. Biologicals 2008, 36 (3), 184–197.
    OpenUrlPubMed
  15. 15.↵
    1. Boyd S.,
    2. Vandenberghe L.
    Convex Optimization. Cambridge University Press, 2004.
  16. 16.↵
    www.fda.ohrms/dockets/ac/05/transcripts/2005-4188t1.pdf.
PreviousNext
Back to top

In This Issue

PDA Journal of Pharmaceutical Science and Technology: 67 (2)
PDA Journal of Pharmaceutical Science and Technology
Vol. 67, Issue 2
March/April 2013
  • 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.
Establishing Acceptable Limits of Residual DNA
(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.
4 + 7 =
Solve this simple math problem and enter the result. E.g. for 1+3, enter 4.
Citation Tools
Establishing Acceptable Limits of Residual DNA
Harry Yang
PDA Journal of Pharmaceutical Science and Technology Mar 2013, 67 (2) 155-163; DOI: 10.5731/pdajpst.2013.00910

Citation Manager Formats

  • BibTeX
  • Bookends
  • EasyBib
  • EndNote (tagged)
  • EndNote 8 (xml)
  • Medlars
  • Mendeley
  • Papers
  • RefWorks Tagged
  • Ref Manager
  • RIS
  • Zotero
Share
Establishing Acceptable Limits of Residual DNA
Harry Yang
PDA Journal of Pharmaceutical Science and Technology Mar 2013, 67 (2) 155-163; DOI: 10.5731/pdajpst.2013.00910
Twitter logo Facebook logo Mendeley logo
  • Tweet Widget
  • Facebook Like
  • Google Plus One

Jump to section

  • Article
    • Abstract
    • Introduction
    • Regulatory Specifications
    • Methods of Risk Assessment
    • Risk-Based Specifications
    • Discussion and Conclusions
    • Acknowledgements
    • References
  • Figures & Data
  • References
  • Info & Metrics
  • PDF

Related Articles

  • No related articles found.
  • PubMed
  • Google Scholar

Cited By...

  • Integrating affinity chromatography in the platform process for Adenovirus purification
  • Dual-mode action of scalable, high-quality engineered stem cell-derived SIRP{alpha}-extracellular vesicles for treating acute liver failure
  • A Bayesian Approach to Residual Host Cell DNA Safety Assessment
  • Google Scholar

More in this TOC Section

  • Quantitative and Qualitative Evaluation of Microorganism Profile Identified in Bioburden Analysis in a Biopharmaceutical Facility in Brazil: Criteria for Classification and Management of Results
  • Evaluation of Extreme Depyrogenation Conditions on the Surface Hydrolytic Resistance of Glass Containers for Pharmaceutical Use
  • A Holistic Approach for Filling Volume Variability Evaluation and Control with Statistical Tool
Show more Research

Similar Articles

Keywords

  • Acceptable limits
  • Infectivity
  • Oncogenicity
  • Residual DNA
  • Risk-based assessment

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