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Research ArticleCONFERENCE PROCEEDING

Need for New Technologies for Detection of Adventitious Agents in Vaccines and Other Biological Products

Laurent Mallet and Lucy Gisonni-Lex
PDA Journal of Pharmaceutical Science and Technology November 2014, 68 (6) 556-562; DOI: https://doi.org/10.5731/pdajpst.2014.01012
Laurent Mallet
1Sanofi Pasteur, Product Conception and Development, Marcy L'Etoile, France; and
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  • For correspondence: Laurent.Mallet@sanofipasteur.com
Lucy Gisonni-Lex
2Sanofi Pasteur, Analytical Research and Development North America, Toronto, Ontario, Canada,
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  • For correspondence: Lucy.Gisonni-Lex@sanofipasteur.com
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Abstract

From an industrial perspective, the conventional in vitro and in vivo assays used for detection of viral contaminants have shown their limitations, as illustrated by the unfortunate detection of porcine circovirus contamination in a licensed rotavirus vaccine. This contamination event illustrates the gaps within the existing adventitious agent strategy and the potential use of new broader molecular detection methods. This paper serves to summarize current testing approaches and challenges, along with opportunities for the use of these new technologies.

LAY ABSTRACT: Testing of biological products is required to ensure the safety of patients. Recently, a licensed vaccine was found to be contaminated with a virus. This contamination did not cause a safety concern to the patients; however, it highlights the need for using new testing methods to control our biological products. This paper introduces the benefits of these new tests and outlines the challenges with the current tests.

  • Adventitious agents
  • Virus detection assays
  • Viral vaccines
  • Cell substrates
  • Biological products
  • Product safety
  • Next-Generation Sequencing
  • Regulatory harmonization

Footnotes

  • CONFERENCE PROCEEDING: Proceedings of the PDA/FDA Advanced Technologies for Virus Detection in the Evaluation of Biologicals Conference: Applications and Challenges Workshop in Bethesda, MD, USA; November 13-14, 2013

  • Guest Editors: Arifa S. Khan (Rockville, MD), Dominick Vacante (Malvern, PA)

  • © PDA, Inc. 2014
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In This Issue

PDA Journal of Pharmaceutical Science and Technology: 68 (6)
PDA Journal of Pharmaceutical Science and Technology
Vol. 68, Issue 6
November/December 2014
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Need for New Technologies for Detection of Adventitious Agents in Vaccines and Other Biological Products
Laurent Mallet, Lucy Gisonni-Lex
PDA Journal of Pharmaceutical Science and Technology Nov 2014, 68 (6) 556-562; DOI: 10.5731/pdajpst.2014.01012
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  • Article
    • Abstract
    • Introduction
    • Routine Testing Strategy for Viral Adventitious Agents
    • Adventitious Agent Testing Key Challenges
    • Potential Applications and Perspectives for New Molecular Methods
    • Challenges and Opportunities for the Introduction of Alternative Broad Molecular Detection Methods
    • Conclusion and Perspectives
    • Conflict of Interest Declaration
    • Acknowledgments
    • Footnotes
    • References
  • Figures & Data
  • References
  • Info & Metrics
  • PDF

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Cited By...

  • Proceedings of the 2023 Viral Clearance Symposium, Session 8: Cell Banks, Advanced Technologies (ATMPs, NGS)
  • k-mer-Based Metagenomics Tools Provide a Fast and Sensitive Approach for the Detection of Viral Contaminants in Biopharmaceutical and Vaccine Manufacturing Applications Using Next-Generation Sequencing
  • Adventitious Virus Detection in Cells by High-Throughput Sequencing of Newly Synthesized RNAs: Unambiguous Differentiation of Cell Infection from Carryover of Viral Nucleic Acids
  • A Multicenter Study To Evaluate the Performance of High-Throughput Sequencing for Virus Detection
  • Google Scholar

More in this TOC Section

CONFERENCE PROCEEDING

  • Proceedings of the 2017 Viral Clearance Symposium, Session 4: Submission Strategies
  • Proceedings of the 2017 Viral Clearance Symposium Session 5: Facility Risk Mitigation
  • Proceedings of the 2017 Viral Clearance Symposium: Conclusion
Show more CONFERENCE PROCEEDING

Needs and Challenges for Using New Technologies

  • The Potential Role of Advanced Technologies for Virus Detection in Development and Regulation of Vaccines
Show more Needs and Challenges for Using New Technologies

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Keywords

  • Adventitious agents
  • Virus detection assays
  • Viral vaccines
  • Cell substrates
  • Biological products
  • Product Safety
  • Next-generation sequencing
  • Regulatory harmonization

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Need for New Technologies for Detection of Adventitious Agents in Vaccines and Other Biological Products
Laurent Mallet, Lucy Gisonni-Lex
PDA Journal of Pharmaceutical Science and Technology Nov 2014, 68 (6) 556-562; DOI: 10.5731/pdajpst.2014.01012

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