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Table of Contents

November/December 2011; Volume 65,Issue 6

Proceedings of the PDA/FDA Adventitious Viruses in Biologics: Detection and Mitigation Strategies Workshop in Bethesda, MD, USA; December 1–3, 2010

Conference Proceeding

  • Introduction

    • Editorial

      • You have access
        Introduction to Workshop: Adventitious Viruses in Biologics—Detection and Mitigation Strategies
        Arifa S. Khan, Patricia Hughes and Michael Wiebe
        PDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 544-546; DOI: https://doi.org/10.5731/pdajpst.2011.00817
  • Plenary Session 1: Keynote

    • Paper

      • You have access
        Evolution of Approaches to Viral Safety Issues for Biological Products
        Anthony S. Lubiniecki
        PDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 547-556; DOI: https://doi.org/10.5731/pdajpst.2011.00818
  • Plenary Session 2: Current Regulatory Approaches for Control of Viral Contamination

    • Paper

      • You have access
        Regulatory Approaches for Control of Viral Contamination of Vaccines
        Shasta McClenahan, Christine Uhlenhaut and Philip R. Krause
        PDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 557-562; DOI: https://doi.org/10.5731/pdajpst.2011.00819
      • You have access
        Risk Mitigation Strategies for Viral Contamination of Biotechnology Products: Consideration of Best Practices
        Amy S. Rosenberg, Barry Cherney, Kurt Brorson, Kathleen Clouse, Steven Kozlowski, Patricia Hughes and Rick Friedman
        PDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 563-567; DOI: https://doi.org/10.5731/pdajpst.2011.00820
    • Slide Presentation

      • You have access
        Current European Regulations for Control of Adventitious Virus Safety
        Johannes Blümel
        PDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 568-579; DOI: https://doi.org/10.5731/pdajpst.2011.00821
  • Plenary Session 3 and 4: Review and Viral Contamination and Case Studies

    • Paper

      • You have access
        Mouse Minute Virus (MMV) Contamination—A Case Study: Detection, Root Cause Determination, and Corrective Actions
        Mark Moody, Washington Alves, Jose Varghese and Fazal Khan
        PDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 580-588; DOI: https://doi.org/10.5731/pdajpst.2011.00824
      • You have access
        Adventitious Agent Risk Assessment Case Study: Evaluation of RotaTeq® for the Presence of Porcine Circovirus
        C. S. Ranucci, T. Tagmyer and P. Duncan
        PDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 589-598; DOI: https://doi.org/10.5731/pdajpst.2011.00827
    • Slide Presentation

      • You have access
        A Biotech Production Facility Contamination Case Study—Minute Mouse Virus
        Jim Skrine
        PDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 599-611; DOI: https://doi.org/10.5731/pdajpst.2011.00823
    • Abstract

      • You have access
        Case Study of Apparent Virus Contamination in Biopharmaceutical Product at Centocor
        Linda C. Hendricks and Dominick A. Vacante
        PDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 612-613; DOI: https://doi.org/10.5731/pdajpst.2011.00825
      • You have access
        Contamination by Porcine Circovirus Type 1: Findings, Investigations, and Learnings
        Isabelle Piérard
        PDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 614; DOI: https://doi.org/10.5731/pdajpst.2011.00826
      • You have access
        Identification and Remediation of a Cell Culture Virus Contamination
        Nathan Jones
        PDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 615; DOI: https://doi.org/10.5731/pdajpst.2011.00822
  • Breakout Session E

    • Session Summary

      • You have access
        Summary of Breakout Session E
        Kurt Brorson and Anthony Lubiniecki
        PDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 616-619; DOI: https://doi.org/10.5731/pdajpst.2011.00828
  • Breakout Session F

    • Paper

      • You have access
        Chlorine Dioxide Remediation of a Virus-Contaminated Manufacturing Facility
        Mark Lutgen
        PDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 620-624; DOI: https://doi.org/10.5731/pdajpst.2011.00830
    • Session Summary

      • You have access
        Summary of Breakout Session F: Facility and Equipment Decontamination Strategies
        Laurie P. Norwood and Kalavati Suvarna
        PDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 625-626; DOI: https://doi.org/10.5731/pdajpst.2011.00829
  • Plenary Session 5: Viral Testing: Existing Assays and Emerging Technologies

    • Paper

      • You have access
        Current Testing Methods and Challenges for Detection of Adventitious Viruses
        Arifa S. Khan
        PDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 627-633; DOI: https://doi.org/10.5731/pdajpst.2011.00831
      • You have access
        Theory and Practice of Conventional Adventitious Virus Testing
        Jens-Peter Gregersen
        PDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 634-644; DOI: https://doi.org/10.5731/pdajpst.2011.00832
      • You have access
        Broadening Our Expectations for Viral Safety Risk Mitigation
        Ivar J. Kljavin
        PDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 645-653; DOI: https://doi.org/10.5731/pdajpst.2011.00833
      • You have access
        Overview of Emerging Technologies To Detect Adventitious Agents
        David Onions
        PDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 654-659; DOI: https://doi.org/10.5731/pdajpst.2011.00834
  • Breakout Session C

    • Session Summary

      • You have access
        Breakout Session C Summary: Current Virus Detection Methods
        Andrew P. Byrnes and Hannelore Willkommen
        PDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 660-662; DOI: https://doi.org/10.5731/pdajpst.2011.00835
  • Breakout Session D

    • Paper

      • You have access
        Massively Parallel Sequencing for the Detection of Adventitious Viruses
        J. L. Kolman
        PDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 663-667; DOI: https://doi.org/10.5731/pdajpst.2011.00836
      • You have access
        Detection of Adventitious Viruses from Biologicals Using a Broad-Spectrum Microbial Detection Array
        Crystal Jaing, Shea Gardner, Kevin McLoughlin, James B. Thissen and Tom Slezak
        PDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 668-674; DOI: https://doi.org/10.5731/pdajpst.2011.00838
      • You have access
        Evaluation of a Single-Platform, Rapid, Nucleic Acid–Based Technology for Detection of Adventitious Contaminants of Cell Culture
        Houman Dehghani, Bill Lawrence and Richard C. Ill
        PDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 675-680; DOI: https://doi.org/10.5731/pdajpst.2011.00840
      • You have access
        Use of DOP-PCR in Non-Specific Virus Detection
        Christine Uhlenhaut, Shasta McClenahan and Philip R. Krause
        PDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 681-684; DOI: https://doi.org/10.5731/pdajpst.2011.00842
      • You have access
        Detection of Latent Retroviruses in Vaccine-related Cell Substrates: Investigation of RT Activity Produced by Chemical Induction of Vero Cells
        Hailun Ma and Arifa S. Khan
        PDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 685-689; DOI: https://doi.org/10.5731/pdajpst.2011.00843
    • Abstract

      • You have access
        Advanced Techniques for Detection and Identification of Viral Contaminants Using the Ibis PLEX-ID Universal Biosensor
        Rangarajan Sampath
        PDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 690; DOI: https://doi.org/10.5731/pdajpst.2011.00837
      • You have access
        A Microarray Platform for Virus Detection and Identification
        David Munroe
        PDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 691; DOI: https://doi.org/10.5731/pdajpst.2011.00839
      • You have access
        Nanostring's nCounter—A True Digital Target Profiling Technology
        Michael Morrow and John Donaldson
        PDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 692; DOI: https://doi.org/10.5731/pdajpst.2011.00841
      • You have access
        PDA Cell Substrate Task Force: Emerging Technologies for Virus Detection Technical Document—A Progress Report
        Kathryn King and Michael Wiebe
        PDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 693; DOI: https://doi.org/10.5731/pdajpst.2011.00844
  • Plenary Session 6: Facility Control and GMP Expectations

    • Paper

      • You have access
        Adventitious Agents: Issues and Considerations during Pre-Approval Reviews and Inspections
        John Eltermann
        PDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 694-697; DOI: https://doi.org/10.5731/pdajpst.2011.00845
    • Slide Presentation

      • You have access
        FDA Post-Approval Expectations for Adventitious Virus Contamination Prevention
        Richard L. Friedman
        PDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 698-712; DOI: https://doi.org/10.5731/pdajpst.2011.00846
  • Breakout Session B

    • Session Summary

      • You have access
        Summary of Breakout Session B: Regulatory Expectations for CGMP
        Robert Sausville and Chantal Cazeault
        PDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 713-714; DOI: https://doi.org/10.5731/pdajpst.2011.00847
  • Plenary Session 7: Process Design Strategies for Prevention of Viral Contaminations

    • Paper

      • You have access
        Practicing Safe Cell Culture: Applied Process Designs for Minimizing Virus Contamination Risk
        Robert D. Kiss
        PDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 715-729; DOI: https://doi.org/10.5731/pdajpst.2011.00852
      • You have access
        Application of Risk Assessments in the Design of the Overall Viral Control Strategy Used during the Manufacture and Testing of Live Virus Vaccines
        Sridhar Pennathur
        PDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 730-736; DOI: https://doi.org/10.5731/pdajpst.2011.00851
    • Slide Presentation

      • You have access
        Viral Safety of Plasma-derived Products
        Mahmood Farshid
        PDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 737-753; DOI: https://doi.org/10.5731/pdajpst.2011.00848
      • You have access
        Application of Quality by Design in the Control of Adventitious Viruses: Gaps in Current Processes in the Prevention of Virus Contaminants
        Barry Cherney
        PDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 754-766; DOI: https://doi.org/10.5731/pdajpst.2011.00849
  • Breakout Session A

    • Session Summary

      • You have access
        Breakout Session A: Elimination or Treatment of High-risk Raw Materials
        Robert Kiss and Roman Drews
        PDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 767-777; DOI: https://doi.org/10.5731/pdajpst.2011.00850
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In This Issue

PDA Journal of Pharmaceutical Science and Technology: 65 (6)
PDA Journal of Pharmaceutical Science and Technology
Vol. 65, Issue 6
November/December 2011
  • Table of Contents
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  • Conference Proceeding
    • Introduction
      • Editorial
    • Plenary Session 1: Keynote
      • Paper
    • Plenary Session 2: Current Regulatory Approaches for Control of Viral Contamination
      • Paper
      • Slide Presentation
    • Plenary Session 3 and 4: Review and Viral Contamination and Case Studies
      • Paper
      • Slide Presentation
      • Abstract
    • Breakout Session E
      • Session Summary
    • Breakout Session F
      • Paper
      • Session Summary
    • Plenary Session 5: Viral Testing: Existing Assays and Emerging Technologies
      • Paper
    • Breakout Session C
      • Session Summary
    • Breakout Session D
      • Paper
      • Abstract
    • Plenary Session 6: Facility Control and GMP Expectations
      • Paper
      • Slide Presentation
    • Breakout Session B
      • Session Summary
    • Plenary Session 7: Process Design Strategies for Prevention of Viral Contaminations
      • Paper
      • Slide Presentation
    • Breakout Session A
      • Session Summary

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