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Research ArticleConference Proceeding - Article

Viral Clearance Integration (Session IV): General Trends, Bracketing, QbD, Virus Preparation Quality Attributes

Hannelore Willkommen
PDA Journal of Pharmaceutical Science and Technology January 2014, 68 (1) 66-82; DOI: https://doi.org/10.5731/pdajpst.2014.00967
Hannelore Willkommen
Regulatory Affairs & Biological Safety Consulting, Langen, Germany
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    A survey of quality attributes of virus spike preparations used in clearance studies. PDA J. Pharm Sci. Technol. 2012, 66 (5), 420–433.
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    ASTM. E2888–12: Standard Practice for Process for Inactivation of Rodent Retrovirus by pH. ASTM International: West Conshohocken, PA, 2012.
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In This Issue

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 Integration (Session IV): General Trends, Bracketing, QbD, Virus Preparation Quality Attributes
Hannelore Willkommen
PDA Journal of Pharmaceutical Science and Technology Jan 2014, 68 (1) 66-82; DOI: 10.5731/pdajpst.2014.00967

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Viral Clearance Integration (Session IV): General Trends, Bracketing, QbD, Virus Preparation Quality Attributes
Hannelore Willkommen
PDA Journal of Pharmaceutical Science and Technology Jan 2014, 68 (1) 66-82; DOI: 10.5731/pdajpst.2014.00967
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  • Article
    • Viral Clearance Integration, Current Trends
    • Platform Data and Bracketing: Using CPP Analytical Tools to Determine the Impact to Total Viral Clearance (P. Alfonso and H. Shen, Janssen)
    • Bracketing Studies for Low pH and Triton X-100 Treatment and Viral Filtration (Glen Bolton, Pfizer)
    • Platform Data Considering Different Antibody Products (David Farb; MacroGenics, Inc.)
    • Platform Processes: Standardization of Low pH Treatment for Inactivation of Retrovirus (J. Ucran and R. Steininger, Acceleron Pharma)
    • RVLP Removal by mAb Purification Process (Min Zhang; Genentech, a Member of the Roche Group)
    • Spike Preparation Quality Attributes: Critical Virus Stock Quality Attributes and Production Parameters (Houman Dehghani, Amgen)
    • Spike Preparation Quality Attributes: Impact of Virus Spike Preparations on Viral Clearance (George Miesegaes, CDER/FDA)
    • References
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  • References
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More in this TOC Section

  • Viral Clearance by Traditional Operations with Significant Knowledge Gaps (Session II): Protein A Chromatography
  • Viral Clearance Using Traditional, Well-Understood Unit Operations (Session I): Anion Exchange Chromatography (AEX)
  • Viral Clearance by Traditional Operations With Significant Knowledge Gaps (Session II): Cation Exchange Chromatography (CEX) and Detergent Inactivation
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