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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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References

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    Center for Biologics Evaluation and Research (CBER). Guidance for Industry: Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indications; FDA: Rockville, MD, February 2010.
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    ICH Topics Q2R1—Validation of Analytical Procedures: Text and Methodology. International Conference on Harmonisation, November 2005.
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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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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
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  • 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
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More in this TOC Section

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

Needs and Challenges for Using New Technologies

  • The Potential Role of Advanced Technologies for Virus Detection in Development and Regulation of Vaccines
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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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