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Research ArticleConference Proceeding - Article

Viral Clearance Using Traditional, Well-Understood Unit Operations (Session I): Low-pH Inactivation

Qi Chen
PDA Journal of Pharmaceutical Science and Technology January 2014, 68 (1) 17-22; DOI: https://doi.org/10.5731/pdajpst.2014.00962
Qi Chen
Genentech, a Member of the Roche Group; Process Virology, 1 DNA Way, Mailstop 10, South San Francisco, CA 94080
Ph.D.
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Article Information

vol. 68 no. 1 17-22
DOI 
https://doi.org/10.5731/pdajpst.2014.00962
PubMed 
24504232

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online February 6, 2014.

Copyright & Usage 
© PDA, Inc. 2014

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Cited By...

  • 10 Citations
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PDA Journal of Pharmaceutical Science and Technology: 68 (1)
PDA Journal of Pharmaceutical Science and Technology
Vol. 68, Issue 1
January/February 2014
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Viral Clearance Using Traditional, Well-Understood Unit Operations (Session I): Low-pH Inactivation
Qi Chen
PDA Journal of Pharmaceutical Science and Technology Jan 2014, 68 (1) 17-22; DOI: 10.5731/pdajpst.2014.00962

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Viral Clearance Using Traditional, Well-Understood Unit Operations (Session I): Low-pH Inactivation
Qi Chen
PDA Journal of Pharmaceutical Science and Technology Jan 2014, 68 (1) 17-22; DOI: 10.5731/pdajpst.2014.00962
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Jump to section

  • Article
    • Background
    • Development of a Low-pH Viral Inactivation (VI) Model and Analysis of an Outlier (Lisa Connell-Crowley, Shivanthi Chinniah, and Pete Hinckley; Amgen)
    • Defining Robust Operating Ranges for Low-pH Inactivation in a mAb Platform Process for Reproducible Viral Clearance (D. Vacante, H. Shen, and T. Cheung; Development, Janssen Pharmaceuticals)
    • Virus Inactivation at Low pH (S. Kobayashi, Chugai Pharmaceuticals)
    • Low pH Viral Inactivation: We're Not Done Yet (Daniel M. Strauss and Dayue Chen, Eli Lilly and Company)
    • Summary
    • References
  • Figures & Data
  • References
  • Info & Metrics
  • PDF

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Cited By...

  • Using Sensitivity Analysis to Simplify the Virus Safety Factor Calculation in the Manufacture of Biopharmaceuticals
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More in this TOC Section

  • Viral Clearance by Traditional Operations With Significant Knowledge Gaps (Session II): Cation Exchange Chromatography (CEX) and Detergent Inactivation
  • Conference Summary: Gaps, Lessons Learned, and Areas for Improvement
  • Emerging Unit Operations (Session III): Hydroxyapatite, Mixed-Mode, and Adsorptive Membrane Chromatography; UV-C Inactivation; Chemical Precipitation
Show more Conference Proceeding - Article

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