Index by Author

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

A

  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

B

  1. Blümel, 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

  2. 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

  3. 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

C

  1. 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

  2. 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

  3. 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

D

  1. 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

  2. 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

  3. 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

  4. Duncan, P.

    1. 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

E

  1. Eltermann, John

    1. 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

F

  1. Farshid, Mahmood

    1. 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

  2. Friedman, Richard L.

    1. 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

  3. Friedman, Rick

    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

G

  1. Gardner, Shea

    1. 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

  2. Gregersen, Jens-Peter

    1. 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

H

  1. Hendricks, Linda C.

    1. 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

  2. Hughes, Patricia

    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. 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

I

  1. Ill, Richard C.

    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

J

  1. Jaing, Crystal

    1. 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

  2. Jones, Nathan

    1. 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

K

  1. Khan, Arifa S.

    1. 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
    2. 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
    3. 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

  2. Khan, Fazal

    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

  3. King, Kathryn

    1. 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

  4. Kiss, Robert

    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

  5. Kiss, Robert D.

    1. 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

  6. Kljavin, Ivar J.

    1. 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

  7. Kolman, J. L.

    1. 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

  8. Kozlowski, Steven

    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

  9. Krause, Philip R.

    1. 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
    2. 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

L

  1. Lawrence, Bill

    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

  2. Lubiniecki, Anthony

    1. 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

  3. Lubiniecki, Anthony S.

    1. 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

  4. Lutgen, Mark

    1. 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

M

  1. Ma, Hailun

    1. 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

  2. McClenahan, Shasta

    1. 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
    2. 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

  3. McLoughlin, Kevin

    1. 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

  4. Moody, Mark

    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

  5. Morrow, Michael

    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

  6. Munroe, David

    1. 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

N

  1. Norwood, Laurie P.

    1. 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

O

  1. Onions, David

    1. 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

P

  1. Pennathur, Sridhar

    1. 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

  2. Piérard, Isabelle

    1. 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

R

  1. Ranucci, C. S.

    1. 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

  2. Rosenberg, Amy S.

    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

S

  1. Sampath, Rangarajan

    1. 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

  2. Sausville, Robert

    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

  3. Skrine, Jim

    1. 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

  4. Slezak, Tom

    1. 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

  5. Suvarna, Kalavati

    1. 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

T

  1. Tagmyer, T.

    1. 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

  2. Thissen, James B.

    1. 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

U

  1. Uhlenhaut, Christine

    1. 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
    2. 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

V

  1. Vacante, Dominick A.

    1. 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

  2. Varghese, Jose

    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

W

  1. Wiebe, Michael

    1. 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
    2. 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

  2. Willkommen, Hannelore

    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
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