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Research ArticleConference Proceeding

Root Cause Investigation of Unusual Results Experienced during Master Cell Bank (MCB) Testing and Characterization

Dayue Chen and Christopher C. Hatfield
PDA Journal of Pharmaceutical Science and Technology September 2010, 64 (5) 465-470;
Dayue Chen
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  • For correspondence: chen_dayue@lilly.com
Christopher C. Hatfield
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References

  1. 1.↵
    1. Chen D.,
    2. Nims R.,
    3. Dusing S.,
    4. Miller P.,
    5. Luo W.,
    6. Quertinmont M.,
    7. Parekh B.,
    8. Poorbaugh J.,
    9. Boose J. A.,
    10. Atkinson E. M.
    Root cause investigation of a viral contamination incident occurred during master cell bank (MCB) testing and characterization—a case study. Biologicals 2008, 36 (6), 393–402.
    OpenUrlCrossRefPubMed
  2. 2.↵
    Points to consider in the characterization of cell lines used to produce biologicals. Center for Biologics Evaluation and Research, Food and Drug Administration, U.S. Department of Health and Human Services, 1993.
  3. 3.↵
    Points to consider in the manufacture and testing of monoclonal antibody production for human use. Center for Biologics Evaluation and Research, Food and Drug Administration, U.S. Department of Health and Human Services, 1997.
  4. 4.↵
    Viral safety evaluation of biotechnology products derived from cell lines of human or animal origin. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH Q5A, 1998.
  5. 5.↵
    Derivation and characterization of cell substrates used for production of biotechnological/biological products. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH Q5D, 1997.
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PDA Journal of Pharmaceutical Science and Technology: 64 (5)
PDA Journal of Pharmaceutical Science and Technology
Vol. 64, Issue 5
September/October 2010
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Root Cause Investigation of Unusual Results Experienced during Master Cell Bank (MCB) Testing and Characterization
Dayue Chen, Christopher C. Hatfield
PDA Journal of Pharmaceutical Science and Technology Sep 2010, 64 (5) 465-470;

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Root Cause Investigation of Unusual Results Experienced during Master Cell Bank (MCB) Testing and Characterization
Dayue Chen, Christopher C. Hatfield
PDA Journal of Pharmaceutical Science and Technology Sep 2010, 64 (5) 465-470;
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    • Abstract
    • Introduction
    • Event Chronology at the Testing Company
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Conference Proceeding

  • Proceedings of the 2017 Viral Clearance Symposium, Session 1.1: Upstream Mitigation, Part 1—Cell Bank and Bulk Harvest Testing
  • Proceedings of the 2017 Viral Clearance Symposium, Session 6: Ensuring Viral Safety in Continuous Processing
  • Proceedings of the 2017 Viral Clearance Symposium, Session 2.1: DSP Unit Operations—Virus Filtration/Inactivation
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Virus Testing

  • Proceedings of the 2017 Viral Clearance Symposium, Session 1.1: Upstream Mitigation, Part 1—Cell Bank and Bulk Harvest Testing
  • Proceedings of the 2017 Viral Clearance Symposium, Session 6: Ensuring Viral Safety in Continuous Processing
  • Proceedings of the 2017 Viral Clearance Symposium, Session 2.1: DSP Unit Operations—Virus Filtration/Inactivation
Show more Virus Testing

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