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Research ArticleProceedings of the 2017 Viral Clearance Symposium

Proceedings of the 2017 Viral Clearance Symposium, Session 4: Submission Strategies

Astrid Schwantes, Rachel Specht and Qi Chen
PDA Journal of Pharmaceutical Science and Technology September 2018, 72 (5) 498-510; DOI: https://doi.org/10.5731/pdajpst.2018.009142
Astrid Schwantes
1Virology Department, Paul-Ehrlich-Institut, Paul-Ehrlich-Strasse 51-59, 63225 Langen, Germany; and
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  • For correspondence: Astrid.Schwantes@pei.de
Rachel Specht
2Process Virology, Genentech, 1 DNA Way South San Francisco, CA 94080, USA
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Qi Chen
2Process Virology, Genentech, 1 DNA Way South San Francisco, CA 94080, USA
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Reference

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PDA Journal of Pharmaceutical Science and Technology: 72 (5)
PDA Journal of Pharmaceutical Science and Technology
Vol. 72, Issue 5
September/October 2018
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Proceedings of the 2017 Viral Clearance Symposium, Session 4: Submission Strategies
Astrid Schwantes, Rachel Specht, Qi Chen
PDA Journal of Pharmaceutical Science and Technology Sep 2018, 72 (5) 498-510; DOI: 10.5731/pdajpst.2018.009142

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Proceedings of the 2017 Viral Clearance Symposium, Session 4: Submission Strategies
Astrid Schwantes, Rachel Specht, Qi Chen
PDA Journal of Pharmaceutical Science and Technology Sep 2018, 72 (5) 498-510; DOI: 10.5731/pdajpst.2018.009142
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  • Article
    • Abstract
    • Background and Session Overview
    • Retrovirus Clearance Risk Evaluation and Clearance Target for Chinese Hamster Ovary Cells
    • Bin Yang, Genentech
    • A Proposal for Future BLA Submissions on Virus Filtration: Parvovirus Removal Studies Only
    • Rachel Specht and Qi Chen, Genentech
    • qPCR as an Alternative to TEM and Infectivity Assays
    • William Rayfield, Merck
    • The Use of RVLP in Research and Development Viral Clearance Studies
    • Moritz Bennecke, Roche Pharma
    • Getting Medicines to Patients Fast
    • Sherrie Curtis, Genetech
    • Streamlining Virus Clearance (VC) Studies to Reduce Costs and Time to Clinic
    • Lisa Connell-Crowley, Just Biotherapeutics
    • Viral Clearance Strategy for Early-Phase Program
    • Mi Jin, Teva Pharmaceuticals
    • ASTM Update on Standards for Low pH Inactivation and Virus Retentive Filtration
    • John Schreffler, Janssen J&J
    • Summary
    • Conflict of Interest Declaration
    • Reference
  • Figures & Data
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  • Proceedings of the 2019 Viral Clearance Symposium, Session 1: Viral Clearance Strategies and Case Studies
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More in this TOC Section

Proceedings of the 2017 Viral Clearance Symposium

  • Proceedings of the 2017 Viral Clearance Symposium, Session 2.1: DSP Unit Operations—Virus Filtration/Inactivation
  • Proceedings of the 2017 Viral Clearance Symposium, Session 2.2: DSP Unit Operations–Purification Unit Operations
  • Proceedings of the 2017 Viral Clearance Symposium—
Show more Proceedings of the 2017 Viral Clearance Symposium

Conference Proceeding

  • Proceedings of the 2017 Viral Clearance Symposium: Conclusion
  • Proceedings of the 2017 Viral Clearance Symposium, Session 1.2: Upstream Mitigation, Part 2—Virus Barrier Filter and HTST
  • Proceedings of the 2017 Viral Clearance Symposium, Session 3: Resin Lifetime
Show more Conference Proceeding

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Keywords

  • Viral clearance
  • Project acceleration
  • Novel format molecules
  • Retrovirus-like particle
  • Quantitative polymerase chain reaction
  • Safety margin

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