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Research ArticleConference Proceedings

Proceedings of the 2019 Viral Clearance Symposium, Session 3: Continuous Processing

Scott Lute and Rachel Specht
PDA Journal of Pharmaceutical Science and Technology July 2022, 76 (4) 315-322; DOI: https://doi.org/10.5731/pdajpst.2021.012679
Scott Lute
1Center for Drug Evaluation and Research, Office of Biotechnology Products, U.S. Food and Drug Administration, 10903 New Hampshire Ave Silver Spring, MD 20993; and
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  • For correspondence: scott.lute@fda.hhs.gov
Rachel Specht
2Process Virology Purification Development, Genentech, a Member of the Roche Group 1 DNA Way, South San Francisco, CA 94080
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Abstract

Successful implementation of continuous processing requires an understanding of how to incorporate viral testing and clearance/inactivation into the process via representative small-scale models. Following the lead of the 2017 Viral Clearance Symposium, a session was devoted to understanding the impact of continuous process conditions on viral safety, how to design process for continuous viral inactivation/removal, and how to leverage existing batch data for a continuous process. In this session, there was a presentation investigating the impact of extended continuous cell culture on the production of endogenous retroviral-like particles, two presentations on the robustness of multicolumn capture chromatography and continuous viral filtration for clearance of viral particles, two talks on leveraging well-characterized batch processing data and scientific knowledge to demonstrate viral clearance capabilities of continuous processing, and finally two presentations related to process designs for continuous viral inactivation. Overall, this session provided additional scientific knowledge to support viral clearance strategies when implementing a continuous manufacturing process.

  • Continuous processing
  • Downstream processing
  • Upstream processing
  • Viral Clearance Symposium
  • Viral clearance
  • multicolumn chromatography
  • © PDA, Inc. 2022
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PDA Journal of Pharmaceutical Science and Technology: 76 (4)
PDA Journal of Pharmaceutical Science and Technology
Vol. 76, Issue 4
July/August 2022
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Proceedings of the 2019 Viral Clearance Symposium, Session 3: Continuous Processing
Scott Lute, Rachel Specht
PDA Journal of Pharmaceutical Science and Technology Jul 2022, 76 (4) 315-322; DOI: 10.5731/pdajpst.2021.012679

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Proceedings of the 2019 Viral Clearance Symposium, Session 3: Continuous Processing
Scott Lute, Rachel Specht
PDA Journal of Pharmaceutical Science and Technology Jul 2022, 76 (4) 315-322; DOI: 10.5731/pdajpst.2021.012679
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More in this TOC Section

  • Proceedings of the 2019 Viral Clearance Symposium, Session 2: New Modalities in Chromatography and Adsorptive Filters
  • Proceedings of the 2019 Viral Clearance Symposium, Session 5: Viral Inactivation
  • Proceedings of the 2019 Viral Clearance Symposium, Session 4: Viral Clearance Strategy and Process Understanding
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Keywords

  • Continuous processing
  • Downstream processing
  • Upstream processing
  • Viral Clearance Symposium
  • Viral clearance
  • multicolumn chromatography

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