Application of Flow Cytometry for Rapid Bioburden Screening in Vaccine Virus Production

References

1. 1.↵
   Food and Drug Administration (FDA). Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing. U.S. FDA: Rockville, MD, September 2004.
2. 2.↵
   1. Read E. K.,
   2. Shah R. B.,
   3. Riley B. S.,
   4. Park J. T.,
   5. Brorson K. A.,
   6. Rathore A. S

   . Process analytical technology (PAT) for biopharmaceutical products: Part II. concepts and applications. Biotechnol. Bioeng. 2010, 105 (2), 285–295.

   OpenUrlPubMed
3. 3.↵
   1. Perdue M. L.,
   2. Arnold F.,
   3. Li S.,
   4. Donabedian A.,
   5. Cioce V.,
   6. Warf T.,
   7. Huebner R

   . The future of cell culture-based influenza vaccine production. Expert Review of Vaccines 2011, 10 (8), 1183–1194.

   OpenUrlCrossRefPubMedWeb of Science
4. 4.↵
   1. Strauss S

   . BARDA funds vaccine makers aiming to phase out eggs. Nature Biotechnol. 2010, 28 (12), 1227–1228.

   OpenUrlPubMed
5. 5.↵
   1. Luginbuhl R. E

   . The commercial production of specific–pathogen-free eggs and chickens: the evolution of an industry. Avian Diseases 2000, 44 (3), 632–637.

   OpenUrlPubMed
6. 6.↵
   1. Jungback C.,
   2. Motitschke A

   . Extraneous agents testing for substrates of avian origin and viral vaccines for poultry: Current provisions and proposals for future approaches. Biologicals: Journal of the International Association of Biological Standardization 2010, 38 (3), 362–365.

   OpenUrlPubMed
7. 7.↵
   1. Fawcett T

   . An introduction to ROC analysis. Pattern Recognition Letters 2006, 27, 861–874.

   OpenUrlCrossRefWeb of Science
8. 8.↵
   International Conference on Harmonization (ICH) Topic (Q2R1). Validation of analytical procedures: Text and methodology. Federal Register 1995, 60, 11260–11262.

   OpenUrl
9. 9.↵
   1. Gunasekera T. S.,
   2. Attfield P. V.,
   3. Veal D. A

   . A flow cytometry method for rapid detection and enumeration of total bacteria in milk. Appl. Environ. Microbiol. 2000, 66 (3), 1228–1232.

   OpenUrlAbstract/FREE Full Text
10. 10.↵
    1. Dreier J.,
    2. Vollmer T.,
    3. Kleesiek K

    . Novel flow cytometry-based screening for bacterial contamination of donor platelet preparations compared with other rapid screening methods. Clin. Chem. 2009, 55 (8), 1492–1502.

    OpenUrlAbstract/FREE Full Text
11. 11.↵
    1. Hammes F.,
    2. Egli T

    . Cytometric methods for measuring bacteria in water: Advantages, pitfalls and applications. Anal. Bioanal. Chem. 2010, 397 (3), 1083–1095.

    OpenUrlPubMed
12. 12.↵
    1. McHugh I. O.,
    2. Tucker A. L

    . Flow cytometry for the rapid detection of bacteria in cell culture production medium. Cytometry. Part A: The Journal of the International Society for Analytical Cytology 2007, 71 (12), 1019–1026.

    OpenUrlPubMed