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

  1. Alves, Washington

    1. 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

  2. Blumel, Johannes

    1. 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

  3. Brorson, Kurt

    1. 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
    2. 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

  4. Byrnes, Andrew P.

    1. 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

  5. Cazeault, Chantal

    1. 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

  6. Cherney, Barry

    1. 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
    2. 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

  7. Clouse, Kathleen

    1. 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

  8. Dehghani, Houman

    1. 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

  9. Donaldson, John

    1. 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

  10. Drews, Roman

    1. 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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