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Research ArticleConference Proceeding

Session 2: Company-Specific Data on Cycled Resin Testing

Johannes Blümel and Kurt Brorson
PDA Journal of Pharmaceutical Science and Technology September 2016, 70 (5) 428-442; DOI: https://doi.org/10.5731/pdajpst.2016.006924
Johannes Blümel
1Paul-Ehrlich-Institut, Virology Department, Paul-Ehrlich-Strasse 51-59, Langen 63225, Germany; and
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  • For correspondence: Johannes.Bluemel@pei.de
Kurt Brorson
2Office of Biotechnology Products, CDER/FDA. 10903 New Hampshire Ave., Silver Spring, MD 20903; (301) 796-2193;
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  • For correspondence: Kurt.Brorson@fda.hhs.gov
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PDA Journal of Pharmaceutical Science and Technology: 70 (5)
PDA Journal of Pharmaceutical Science and Technology
Vol. 70, Issue 5
September/October 2016
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Session 2: Company-Specific Data on Cycled Resin Testing
Johannes Blümel, Kurt Brorson
PDA Journal of Pharmaceutical Science and Technology Sep 2016, 70 (5) 428-442; DOI: 10.5731/pdajpst.2016.006924

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Session 2: Company-Specific Data on Cycled Resin Testing
Johannes Blümel, Kurt Brorson
PDA Journal of Pharmaceutical Science and Technology Sep 2016, 70 (5) 428-442; DOI: 10.5731/pdajpst.2016.006924
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  • Article
    • Background
    • Review of Viral Clearance Strategies for Cycled Chromatography Resins (Glen Bolton; Amgen)
    • Optimization of Viral Clearance Strategies (Martina Kopp; Amgen)
    • Viral Clearance Studies with New and Cycled Resins at Biogen (Brad Stanley; Biogen)
    • Consistent Virus Clearance in Reuse Resins (L. Norling and Q. Chen; Genentech)
    • An Alternative Approach to Evaluation of Viral Clearance on New versus End-of-Life AEX Chromatography Resin (C. Gallo, A. Sacramo, and S. Sun; Pfizer)
    • Virus Clearance with Chromatography Media Reuse for a mAb Process (E. Wilson; GSK)
    • AEX Resin Aging for Viral Clearance Studies (Richard Chen; Eli Lilly)
    • Impact of Cycled Chromatography Resin on Viral Clearance (K. Cai; MedImmune)
    • Summary
    • References
  • Figures & Data
  • References
  • Info & Metrics
  • PDF

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Cited By...

  • Proceedings of the 2019 Viral Clearance Symposium, Session 4: Viral Clearance Strategy and Process Understanding
  • Retrospective Evaluation of Cycled Resin in Viral Clearance Studies--A Multiple Company Collaboration
  • Proceedings of the 2017 Viral Clearance Symposium, Session 3: Resin Lifetime
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More in this TOC Section

  • Proceedings of the 2017 Viral Clearance Symposium, Session 4: Submission Strategies
  • Proceedings of the 2017 Viral Clearance Symposium Session 5: Facility Risk Mitigation
  • Proceedings of the 2017 Viral Clearance Symposium: Conclusion
Show more Conference Proceeding

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