Table of Contents

Conference Proceeding

• Introduction

  • Editorial

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      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

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      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

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      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
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      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

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      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

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      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
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      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

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      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

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      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
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      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
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      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

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      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

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      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

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      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

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      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
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      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
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      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
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      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

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      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

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      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
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      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
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      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
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      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
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      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

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      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
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      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
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      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
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      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

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      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

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      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

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      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

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      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
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      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

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      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
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      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

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      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