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Research ArticleConference Proceeding - Article

Viral Clearance Using Traditional, Well-Understood Unit Operations (Session I): Virus-Retentive Filtration

Dayue Chen
PDA Journal of Pharmaceutical Science and Technology January 2014, 68 (1) 38-50; DOI: https://doi.org/10.5731/pdajpst.2014.00965
Dayue Chen
Eli Lilly and Company, Indianapolis, IN
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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): Virus-Retentive Filtration
Dayue Chen
PDA Journal of Pharmaceutical Science and Technology Jan 2014, 68 (1) 38-50; DOI: 10.5731/pdajpst.2014.00965

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Viral Clearance Using Traditional, Well-Understood Unit Operations (Session I): Virus-Retentive Filtration
Dayue Chen
PDA Journal of Pharmaceutical Science and Technology Jan 2014, 68 (1) 38-50; DOI: 10.5731/pdajpst.2014.00965
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  • Article
    • Background
    • Generic Validation
    • Characterization of the Virus-Retentive Filtration Unit Operation
    • Generic Validation with a Single Model Virus (Eva Gefroh, Amgen)
    • Virus-Retentive Filtration, Genentech Experience (Rachel Specht, Aimee Durbin; Genentech, a Member of the Roche Group)
    • Defining Robust Operating Ranges for Virus-Retentive Filtration in a mAb Platform Process for Reproducible Viral Clearance (Hong Shen, Dominick Vacante, and Pedro Alfonso; Active Pharmaceutical Ingredient - Large Molecule, Janssen Pharmaceuticals, Johnson & Johnson)
    • Evaluation of a 20 nm Hollow-Fiber Filter for Parvovirus Clearance (Adith Venkiteshwaran, J. Nolting, and Dayue Chen; Eli Lilly and Company)
    • Parvovirus Filter Protection via CEX Guard Columns (J. Bill Jr.; Genentech, a Member of the Roche Group)
    • Systematic Approach for Characterization of the Virus-Retentive Filtration Unit Operation: Additional Knowledge or Extra Frustration? (D. Chen, A. Venkiteshwaran, and D. Strauss; Eli Lilly and Company)
    • Summary
    • References
  • Figures & Data
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Cited By...

  • Using Sensitivity Analysis to Simplify the Virus Safety Factor Calculation in the Manufacture of Biopharmaceuticals
  • Viral Clearance Using Traditional, Well-Understood Unit Operations Session 1.2: Virus-Retentive Filtration
  • Viral Clearance of Traditional Unit Operations: Virus-Retentive Filtration
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More in this TOC Section

  • Emerging Unit Operations (Session III): Hydroxyapatite, Mixed-Mode, and Adsorptive Membrane Chromatography; UV-C Inactivation; Chemical Precipitation
  • Viral Clearance Integration (Session IV): General Trends, Bracketing, QbD, Virus Preparation Quality Attributes
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