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Research ArticleConference Proceedings

Proceedings of the 2023 Viral Clearance Symposium, Session 5: Viral Clearance Strategy and Process Understanding

Kurt Brorson and Sean O’Donnell
PDA Journal of Pharmaceutical Science and Technology March 2024, 78 (2) 176-186; DOI: https://doi.org/10.5731/pdajpst.2024.002245
Kurt Brorson
1Parexel International, Florida (USA, decentralized); and
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  • For correspondence: kurt.brorson@parexel.com
Sean O’Donnell
2Eli Lilly & Co., Corporate Center, Indianapolis, IN 42177
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Article Information

vol. 78 no. 2 176-186
DOI 
https://doi.org/10.5731/pdajpst.2024.002245
PubMed 
38609147

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online April 12, 2024.

Copyright & Usage 
© PDA, Inc. 2024

Author Information

  1. Kurt Brorson1,* and
  2. Sean O’Donnell2
  1. 1Parexel International, Florida (USA, decentralized); and
  2. 2Eli Lilly & Co., Corporate Center, Indianapolis, IN 42177
  1. ↵* Corresponding Author: Parexel International, FL (Decentralized). E-mail: kurt.brorson@parexel.com
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PDA Journal of Pharmaceutical Science and Technology: 78 (2)
PDA Journal of Pharmaceutical Science and Technology
Vol. 78, Issue 2
March/April 2024
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Proceedings of the 2023 Viral Clearance Symposium, Session 5: Viral Clearance Strategy and Process Understanding
Kurt Brorson, Sean O’Donnell
PDA Journal of Pharmaceutical Science and Technology Mar 2024, 78 (2) 176-186; DOI: 10.5731/pdajpst.2024.002245
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  • Article
    • Abstract
    • Session Introduction & Goals
    • Virus Safety: Learning from the Past (Helmut Winter, Boehringer-Ingelheim)
    • A Challenge in Viral Clearance Determination: Estimation of TCID50 for Low Virus Concentrations (Anca Arentsen, Novo Nordisk)
    • Enhancing Developability of Viral Clearance in Downstream Unit Operations by Leveraging a Toolbox of Virus Surrogate-Based Methodologies (Lukas Döring, Rentschler Biopharma SE and Karlsruhe Institute of Technology)
    • The Importance of Virus Segregation: Sensitivity Analysis of Carryover (Soren Kamstrup, Novo Nordisk)
    • Cleaning Agents that Effectively Inactivate Baculovirus on Manufacturing Surfaces (Sean O’Donnell, Eli Lilly)
    • New Paradigms: Evaluation of Cygnus Alpha RVLP Kit against In-House Method (William Rayfield, Merck & Co.)
    • RVLP Burden Evaluation in a Continuous Process (Beth Larimore, Evotec)
    • ASTM Standard Initiative Update and Path Forward (John Schreffler, Vir Biotherapeutics)
    • Conflict of Interest Declaration
    • References
  • Figures & Data
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More in this TOC Section

  • Proceedings of the 2023 Viral Clearance Symposium: 2023 VCS Summary, Pending Questions, and Next Steps
  • Proceedings of the 2023 Viral Clearance Symposium, Session 1: Regulatory Updates
  • Proceedings of the 2023 Viral Clearance Symposium, Session 4: Continuous Processing
Show more Conference Proceedings

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Keywords

  • TCID50
  • ASTM
  • Q-PCR
  • Viral clearance
  • Design of Experiments
  • Virus-like particles
  • Outlier analysis
  • Virus carryover
  • Continuous processing

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Proceedings of the 2023 Viral Clearance Symposium, Session 5: Viral Clearance Strategy and Process Understanding
Kurt Brorson, Sean O’Donnell
PDA Journal of Pharmaceutical Science and Technology Mar 2024, 78 (2) 176-186; DOI: 10.5731/pdajpst.2024.002245

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