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Parenteral Drug Association Connecting People, Science and Regulation ®

2014 PDA/FDA Virus & TSE Safety Conference

  • Agenda
  • Olivier Andreoletti
    (Session P9) Detection of Variant CJD and sCJD Infectivity in the Blood
  • Paul Barone, PhD
    (Session P3) An Update on the Activities of the Consortium on Adventitious Agent Contamination in Biomanufacturing
  • Christian Bell, PhD
    (Session P7) Bringing QbD to Life - The First FDA Approved Viral Clearance Design Space
  • Johannes Bluemel, PhD
    (Session P1) Regulatory Perspective from Europe
  • Kurt Brorson, PhD P1
    (Session P1) Current viral safety approaches for Biopharmaceuticals
  • Kurt Brorson, PhD P8
    (Session P8) Regulatory Considerations Related to Clinical vs. Commercial Development
  • Jean Pol Cassart, PhD
    (Interest Group Session) Virus Detection Technologies Subgroup B
  • Dayue Chen, PhD P5
    (Session P5) Mitigation of Viral Risk Associated with Rabbit Polyclonal Antibodies Used during Cell Line Generation
  • Dayue Chen, PhD P6
    (Session P6) Laboratory Scale Studies Provides Scientific Basis for Setting Appropriate Controls in cGMP Manufacturing for the Virus Filtration Unit Operation Presentation is not authorized for distribution
  • Eric Delwart, PhD
    (Session P2) Update on Progress in Applying Pan Virus Detection Methods/Deep-Sequencing with Implications to Biotechnology Processes
  • Linda Detwiler, DVM
    Presented By: Silivia Kreindel, DVM (Session P9) Update on BSE Worldwide
  • Bryan Dransart
    (Session P8) Optimization of Commercial Strategies for Marketing Applications
  • Marc Eloit
    (Session P2) Analysis by NGS of the Viral Diversity in Biological Raw Materials
  • Chris Gallo
    (Session P7) Development of a Modular Virus Clearance Package for Anion Exchange Chromatography (AEX) Using Bacteriophage and a Model Retrovirus and Parvovirus
  • Luisa Gregori, PhD
    (Session P9) FDA Update on Development of Reference Materials for CJD and vCJD Infectivity
  • Albrecht Groener, PhD
    (Session P10) Risk of TSE Infectivity for Biologicals
  • Arifa Khan, PhD P2
    (Session P2) Evaluation of Cell Substrates Using Advanced Virus Detection Technologies
  • Arifa Khan, PhD IG
    (Interest Group Session) Advanced Virus Detection Technologies
  • Robert Kiss, PhD
    (Session P3) Current State of Bioprocess Risk Mitigation for Large Scale Cell Culture Processes
  • Ivar Kljavin, PhD
    (Session P2) Pitfalls of the Infectious Agent Cell Based Methods used to Screen Pre-harvest CHO Cell Culture Samples for Viruses
  • Thomas R. Kreil, PhD
    (Session P7) HEV Reduction Studies Presentation is not authorized for distribution
  • Oscar Jun Adan Kubo, PhD
    (Session P6) Virus Behavior during Filtration is Affected by Structure of Filter Membrane and Brownian Motion of Virus
  • Scott Lute
    (Session P6) Virus filtration Breakthrough Risks and Mitigation Strategies
  • Siemon Ng, PhD
    (Interest Group Session) Advanced Virus Detection Technologies Interest Group: Subgroup A
  • Sean O'Donnell, PhD
    (Session P8) Phase Appropriate Viral Clearance Strategies for Clinical and Commercial Development of Biologics
  • Christian Sauder
    (Session P5) Epidemiology and Host Spectrum of Borna Disease Virus
  • Hermann Schaetzl, MD
    (Session P10) Cellular Uptake and Degradation of PrP-TSE; Relationship to Infectivity
  • Nicole Schmitz
    (Session P4) Challenges Associated with the Use of New Human Cell Lines for the Production of Biotherapeutics: PER.C6
  • Paul Shabram
    (Session P4) Challenges Associated with the Use of New Human Cell Lines for the Production of Biotherapeutics: A549
  • Maria Cecilia Tami
    (Session P5) Regulatory Issues Surrounding the Use of Animal Derived Reagents in Cell Line Development
  • John Thompson, PhD
    (Interest Group Session) Advanced Virus Detection Technologies Users Interest Group: Subgroup C and Subgroup D
  • Mike Wiebe, PhD
    (Session P3) Update on The CAACB Virus Contamination Project
  • Keisuke Yusa, PhD
    (Session P1) Virus Safety for Biopharmaceuticals and Cell/Tissue Processed Products