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Research ArticleProceedings of the 2017 Viral Clearance Symposium

Proceedings of the 2017 Viral Clearance Symposium, Session 2.2: DSP Unit Operations–Purification Unit Operations

David Roush and Thomas R. Kreil
PDA Journal of Pharmaceutical Science and Technology September 2018, 72 (5) 479-487; DOI: https://doi.org/10.5731/pdajpst.2018.009126
David Roush
1Bioprocess Development/Biologics Research, Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ, USA; and
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  • For correspondence: david_roush@merck.com
Thomas R. Kreil
2Shire, Vienna A-1220, Austria
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Reference

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    Viral Clearance Using Traditional, Well-Understood Unit Operations: Session 1.2. Anion Exchange Chromatography; and Session 1.3. Protein A Chromatography. PDA J. Pharm. Sci. Technol 2015, 69 (1), 154–162.
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    1. Roush D.
    Viral Clearance Using Traditional, Well-Understood Unit Operations (Session I): Anion Exchange Chromatography (AEX). PDA J. Pharm. Sci. Technol 2014, 68 (1), 23–29.
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    Emerging Unit Operations (Session III): Hydroxyapatite, Mixed-Mode, and Adsorptive Membrane Chromatography; UV-C Inactivation; Chemical Precipitation. PDA J. Pharm. Sci. Technol 2014, 68 (1), 51–65.
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    Session 3.1: Protein A, Hydroxyapatite, and Mixed-Mode Chromatography. PDA J. Pharm. Sci. Technol 2016, 70 (5), 443–450.
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    Session 3.2: Viral Clearance of Emerging Unit Operations: Membrane Chromatography, Other Methods, Etc. PDA J. Pharm. Sci. Technol 2016, 70 (5), 451–461.
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    A Step-Wise Approach to Define Binding Mechanisms of Surrogate Viral Particles to Multi-Modal Anion Exchange Resin in a Single Solute System. Biotechnol. Bioeng 2017, 114 (7), 1487–1494.
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    The Step-Wise Framework to Design a Chromatography-Based Hydrophobicity Assay for Viral Particles. J. Chromatogr. B. Analyt. Technol. Biomed. Life Sci 2017, 1061–1062, 430–437.
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    Comprehensive Evaluation of Emerging Anion Exchange Adsorber Technologies for Improving Capacity and Manufacturing Agility. Presented at American Chemical Society Spring National Meeting, San Francisco, CA, April 2–6, 2017; BIOT paper 48.
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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 2.2: DSP Unit Operations–Purification Unit Operations
David Roush, Thomas R. Kreil
PDA Journal of Pharmaceutical Science and Technology Sep 2018, 72 (5) 479-487; DOI: 10.5731/pdajpst.2018.009126

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Proceedings of the 2017 Viral Clearance Symposium, Session 2.2: DSP Unit Operations–Purification Unit Operations
David Roush, Thomas R. Kreil
PDA Journal of Pharmaceutical Science and Technology Sep 2018, 72 (5) 479-487; DOI: 10.5731/pdajpst.2018.009126
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Proceedings of the 2017 Viral Clearance Symposium

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  • Proceedings of the 2017 Viral Clearance Symposium, Session 1.1: Upstream Mitigation, Part 1—Cell Bank and Bulk Harvest Testing
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Conference Proceeding

  • Proceedings of the 2017 Viral Clearance Symposium Session 5: Facility Risk Mitigation
  • 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 4: Submission Strategies
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Keywords

  • Viral clearance
  • Downstream processing
  • Affinity chromatography
  • Ion exchange chromatography
  • Multimodal chromatography
  • Membrane adsorbers

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