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Research ArticleProceedings of the 2017 Viral Clearance Symposium

Proceedings of the 2017 Viral Clearance Symposium, Session 6: Ensuring Viral Safety in Continuous Processing

Sarah A. Johnson and David Roush
PDA Journal of Pharmaceutical Science and Technology September 2018, 72 (5) 516-524; DOI: https://doi.org/10.5731/pdajpst.2018.009183
Sarah A. Johnson
1Center for Drug Evaluation and Research, Office of Biotechnology Products, U.S. Food and Drug Administration, Silver Spring, MD; and
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  • For correspondence: sarah.johnson1@fda.hhs.gov
David Roush
2Bioprocess Development/Biologics Research, Merck & Co., Inc., Kenilworth, NJ, USA
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Abstract

To ensure successful scale-up of continuous processing to large-scale production, it is necessary to seamlessly incorporate viral testing and clearance/inactivation into representative small-scale models. For the first time, a session devoted to the adaptation of standard viral clearance/inactivation unit operations to continuous processing was held at the Viral Clearance Symposium (VCS), with an emphasis on design of valid small-scale models. In this session, the presentations and subsequent discussions identified challenges as well as pathways forward for these emerging technologies. In the first two talks, two different strategies on how to validate continuous low pH viral inactivation (VI) were discussed, focusing on molecule stability and XMuLV inactivation kinetics in the lower residence times of continuous manufacturing, in addition to mathematics-based modeling of continuous viral inactivation processes. The third talk in the session presented a strategy to adapt weak anion exchange chromatography to a continuous manufacturing process by taking advantage of the elution pulses from bind and elute chromatography. The final and fourth talk provided data from novel spiking strategies in consideration of the high, but fluctuating, product titers in the context of continuous flow encountered in continuous manufacturing processes.

LAY ABSTRACT: To ensure successful scale-up of continuous processing to large-scale production, it is necessary to seamlessly incorporate viral testing and clearance/inactivation into representative small-scale models.

For example, in this session, strategies to validate continuous low pH viral inactivation were discussed.

In addition, data from novel spiking strategies in consideration of the high, but fluctuating, product titers in the context of continuous manufacturing processes were presented.

  • Viral clearance
  • Continuous processing
  • Small-scale model
  • Chromatography
  • Virus inactivation
  • Virus-spiking strategy
  • © PDA, Inc. 2018
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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 6: Ensuring Viral Safety in Continuous Processing
Sarah A. Johnson, David Roush
PDA Journal of Pharmaceutical Science and Technology Sep 2018, 72 (5) 516-524; DOI: 10.5731/pdajpst.2018.009183

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Proceedings of the 2017 Viral Clearance Symposium, Session 6: Ensuring Viral Safety in Continuous Processing
Sarah A. Johnson, David Roush
PDA Journal of Pharmaceutical Science and Technology Sep 2018, 72 (5) 516-524; DOI: 10.5731/pdajpst.2018.009183
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    • Alternative Strategies for Viral Validation of a Continuous Viral Filtration Step
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More in this TOC Section

Proceedings of the 2017 Viral Clearance Symposium

  • Proceedings of the 2017 Viral Clearance Symposium, Session 2.2: DSP Unit Operations–Purification Unit Operations
  • Proceedings of the 2017 Viral Clearance Symposium—
  • Proceedings of the 2017 Viral Clearance Symposium Session 5: Facility Risk Mitigation
Show more Proceedings of the 2017 Viral Clearance Symposium

Conference Proceeding

  • Proceedings of the 2017 Viral Clearance Symposium, Session 2.2: DSP Unit Operations–Purification Unit Operations
  • Proceedings of the 2017 Viral Clearance Symposium—
  • Proceedings of the 2017 Viral Clearance Symposium Session 5: Facility Risk Mitigation
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Keywords

  • Viral clearance
  • Continuous processing
  • Small-scale model
  • Chromatography
  • Virus inactivation
  • Virus-spiking strategy

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