Risk Mitigation Strategies for Viral Contamination of Biotechnology Products: Consideration of Best Practices

References

1. 1.↵
   1. Boschetti N.,
   2. Wyss K.,
   3. Mischler A.,
   4. Hostettler T.,
   5. Kempf C.

   Stability of minute virus of mice against temperature and sodium hydroxide. Biologicals 2003, 31 (3), 181–185.

   OpenUrlCrossRefPubMedWeb of Science
2. 2.↵
   1. Boschetti N.,
   2. Niederhauser I.,
   3. Kempf C.,
   4. Stühler A.,
   5. Löwer J.,
   6. Blümel J.

   Different susceptibility of B19 virus and mice minute virus to low pH treatment. Transfusion 2004, 44 (7), 1079–1086.

   OpenUrlPubMed
3. 3.↵
   1. Garnick R. L.

   Raw materials as a source of contamination in large-scale cell culture. Dev. Biol. Stand. 1998, 93, 21–29.

   OpenUrlPubMedWeb of Science
4. 4.↵
   1. Brown F.,
   2. Lubiniecki A. S.

   1. Lee C. K.

   Issues of Biological Assays for Viral Vaccines. In Viral Safety and Evaluation of Viral Clearance from Biopharmaceutical Products; Brown F., Lubiniecki A. S., Eds.; Karger: Basel, 1996.
5. 5.↵
   1. Willkommen H.

   Presentation at PDA/FDA Adventitious Viruses in Biologics, December, 2010. Hannelore.wilkommen{at}gmx.de.
6. 6.↵
   1. Gilbert N.

   Livestock plagues are spreading. Nature News February 11, 2011, doi:10.1038/news.2011.87.
7. 7.↵
   ILRI Clippings. Animal surveillance needed to stop bird flu and other human epidemics—World Bank. March 11, 2011 http://ilriclippings.wordpress.com/2011/03/11/animal-surveillance-needed-to-stop-bird-flu-and-other-human-epidemics-world-bank/
8. 8.↵
   Genzyme Press Release, http://www.genzyme.com/corp/media/GENZ%20PR-062509.asp
9. 9.↵
   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 (Pt. 10), 2837–2845.

   OpenUrlAbstract/FREE Full Text
10. 10.↵
    1. Smith A. W.,
    2. Iversen P. L.,
    3. Skilling D. E.,
    4. Stein D. A.,
    5. Bok K.,
    6. Matson D. O.

    Vesivirus viremia and seroprevalence in humans. J. Med. Virol. 2006, 78 (5), 693–701.

    OpenUrlCrossRefPubMedWeb of Science
11. 11.↵
    1. Blumel J.,
    2. Brorson K.

    1. Miesegaes G.,
    2. Bailey M.,
    3. Willkommen H.,
    4. Chen Q.,
    5. Rousch D.

    Viral Clearance Symposium Participants, Blumel J., Brorson K. Proceedings of the 2009 Viral Clearance Symposium. Dev. Biol. (Basel) 2010, 133, 3–101.

    OpenUrlPubMed