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

References

1. 1.↵
   World Health Organization (WHO). Recommendations for the evaluation of animal cell cultures as cell substrates for the manufacture of biological medicinal products and for the characterization of cell banks. Sixty-First Report; World Health Organization, Annex 3, WHO Technical Report Series No. 978; Geneva, Switzerland, 2013.

   Google Scholar
2. 2.↵
   International Conference on Harmonisation. ICH Topics Q5A(R1)—Viral safety evaluation of biotechnology products derived from cell lines of human or animal origin. 23 Sept 1999.

   Google Scholar
3. 3.↵
   Code of Federal Regulations, Title 9, Animal and Animal Products (current year): Part 113.53, Requirements for ingredients of animal origin used for production of biologics; Office of the Federal Register, National Archives and Records Administration, U.S. Government Printing Office: Washington, DC; January 1, 2011.

   Google Scholar
4. 4.↵
   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.

   Google Scholar
5. 5.
   CBER. Points to consider in the characterization of cell lines used to produce biologicals. FDA: Rockville, MD, July 1993.

   Google Scholar
6. 6.
   CBER. Points to consider in the manufacture and testing of monoclonal antibody products for human use. U.S. FDA: Rockville, MD, February 1997.

   Google Scholar
7. 7.
   Chapter 5.2.3, Cell Substrates for the Production of Vaccines for Human Use. European Pharmacopoeia, 8th ed., 2013.

   Google Scholar
8. 8.
   Chapter 2.6.16, Tests for Extraneous Agents in Viral Vaccines for Human Use. European Pharmacopoeia, 8th ed., 2013.

   Google Scholar
9. 9.↵
   ICH Topics Q2R1—Validation of Analytical Procedures: Text and Methodology. International Conference on Harmonisation, November 2005.

   Google Scholar
10. 10.↵
    1. Sheets R. L.

    Opinion on adventitious agents testing for vaccines: Why do we worry so much about adventitious agents in vaccines? Vaccine 2013, 31 (26), 2791–2795.

    OpenUrlPubMedGoogle Scholar
11. 11.↵
    1. Gombold J.,
    2. Karakasidis S.,
    3. Niksa P.,
    4. Podczasy J.,
    5. Neumann K.,
    6. Richardson J.,
    7. Sane N.,
    8. Johnson-Leva R.,
    9. Randolph V.,
    10. Sadoff J.,
    11. Minor P.,
    12. Schmidt A.,
    13. Duncan P.,
    14. Sheets R. L.

    Systematic evaluation of in vitro and in vivo adventitious virus assays for the detection of viral contamination of cell banks and biological products. Vaccine 2014, 32 (24) 2916–2926.

    OpenUrlPubMedGoogle Scholar
12. 12.↵
    1. Victoria J. G.,
    2. Wang C.,
    3. Jones M. S.,
    4. Jaing C.,
    5. McLoughlin K.,
    6. Gardner S.,
    7. Delwart E. L.

    Viral nucleic acids in live-attenuated vaccines: detection of minority variants and an adventitious virus. J. Virol. 2010, 84 (12), 6033–6040.

    OpenUrlAbstract/FREE Full TextGoogle Scholar
13. 13.↵
    1. Onions D.,
    2. Kolman J.

    Massively parallel sequencing, a new method for detecting adventitious agents. Biologicals 2010, 38 (3), 377–380.

    OpenUrlPubMedGoogle Scholar
14. 14.↵
    1. Onions D.,
    2. Côté C.,
    3. Love B.,
    4. Toms B.,
    5. Koduri S.,
    6. Armstrong A.,
    7. Chang A.,
    8. Kolman J.

    Ensuring the safety of vaccine cell substrates by massively parallel sequencing of the transcriptome. Vaccine 2011, 29 (41), 7117–7121.

    OpenUrlCrossRefPubMedWeb of ScienceGoogle Scholar
15. 15.↵
    1. Cheval J.,
    2. Sauvage V.,
    3. Frangeul L.,
    4. Dacheux L.,
    5. Guigon G.,
    6. Dumey N.,
    7. Pariente K.,
    8. Rousseaux C.,
    9. Dorange F.,
    10. Berthet N.,
    11. Brisse S.,
    12. Moszer I.,
    13. Bourhy H.,
    14. Manuguerra C. J.,
    15. Lecuit M.,
    16. Burguiere A.,
    17. Caro V.,
    18. Eloit M.

    Evaluation of high-throughput sequencing for identifying known and unknown viruses in biological samples. J. Clin. Microbiol. 2011, 49 (9), 3268–3275.

    OpenUrlAbstract/FREE Full TextGoogle Scholar