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
Alves, Washington
- You have accessMouse Minute Virus (MMV) Contamination—A Case Study: Detection, Root Cause Determination, and Corrective ActionsMark Moody, Washington Alves, Jose Varghese and Fazal KhanPDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 580-588; DOI: https://doi.org/10.5731/pdajpst.2011.00824
B
Blümel, Johannes
- You have accessCurrent European Regulations for Control of Adventitious Virus SafetyJohannes BlümelPDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 568-579; DOI: https://doi.org/10.5731/pdajpst.2011.00821
Brorson, Kurt
- You have accessRisk Mitigation Strategies for Viral Contamination of Biotechnology Products: Consideration of Best PracticesAmy S. Rosenberg, Barry Cherney, Kurt Brorson, Kathleen Clouse, Steven Kozlowski, Patricia Hughes and Rick FriedmanPDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 563-567; DOI: https://doi.org/10.5731/pdajpst.2011.00820
- You have accessSummary of Breakout Session EKurt Brorson and Anthony LubinieckiPDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 616-619; DOI: https://doi.org/10.5731/pdajpst.2011.00828
Byrnes, Andrew P.
- You have accessBreakout Session C Summary: Current Virus Detection MethodsAndrew P. Byrnes and Hannelore WillkommenPDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 660-662; DOI: https://doi.org/10.5731/pdajpst.2011.00835
C
Cazeault, Chantal
- You have accessSummary of Breakout Session B: Regulatory Expectations for CGMPRobert Sausville and Chantal CazeaultPDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 713-714; DOI: https://doi.org/10.5731/pdajpst.2011.00847
Cherney, Barry
- You have accessRisk Mitigation Strategies for Viral Contamination of Biotechnology Products: Consideration of Best PracticesAmy S. Rosenberg, Barry Cherney, Kurt Brorson, Kathleen Clouse, Steven Kozlowski, Patricia Hughes and Rick FriedmanPDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 563-567; DOI: https://doi.org/10.5731/pdajpst.2011.00820
- You have accessApplication of Quality by Design in the Control of Adventitious Viruses: Gaps in Current Processes in the Prevention of Virus ContaminantsBarry CherneyPDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 754-766; DOI: https://doi.org/10.5731/pdajpst.2011.00849
Clouse, Kathleen
- You have accessRisk Mitigation Strategies for Viral Contamination of Biotechnology Products: Consideration of Best PracticesAmy S. Rosenberg, Barry Cherney, Kurt Brorson, Kathleen Clouse, Steven Kozlowski, Patricia Hughes and Rick FriedmanPDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 563-567; DOI: https://doi.org/10.5731/pdajpst.2011.00820
D
Dehghani, Houman
- You have accessEvaluation of a Single-Platform, Rapid, Nucleic Acid–Based Technology for Detection of Adventitious Contaminants of Cell CultureHouman Dehghani, Bill Lawrence and Richard C. IllPDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 675-680; DOI: https://doi.org/10.5731/pdajpst.2011.00840
Donaldson, John
- You have accessNanostring's nCounter—A True Digital Target Profiling TechnologyMichael Morrow and John DonaldsonPDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 692; DOI: https://doi.org/10.5731/pdajpst.2011.00841
Drews, Roman
- You have accessBreakout Session A: Elimination or Treatment of High-risk Raw MaterialsRobert Kiss and Roman DrewsPDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 767-777; DOI: https://doi.org/10.5731/pdajpst.2011.00850
Duncan, P.
- You have accessAdventitious Agent Risk Assessment Case Study: Evaluation of RotaTeq® for the Presence of Porcine CircovirusC. S. Ranucci, T. Tagmyer and P. DuncanPDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 589-598; DOI: https://doi.org/10.5731/pdajpst.2011.00827
E
Eltermann, John
- You have accessAdventitious Agents: Issues and Considerations during Pre-Approval Reviews and InspectionsJohn EltermannPDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 694-697; DOI: https://doi.org/10.5731/pdajpst.2011.00845
F
Farshid, Mahmood
- You have accessViral Safety of Plasma-derived ProductsMahmood FarshidPDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 737-753; DOI: https://doi.org/10.5731/pdajpst.2011.00848
Friedman, Richard L.
- You have accessFDA Post-Approval Expectations for Adventitious Virus Contamination PreventionRichard L. FriedmanPDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 698-712; DOI: https://doi.org/10.5731/pdajpst.2011.00846
Friedman, Rick
- You have accessRisk Mitigation Strategies for Viral Contamination of Biotechnology Products: Consideration of Best PracticesAmy S. Rosenberg, Barry Cherney, Kurt Brorson, Kathleen Clouse, Steven Kozlowski, Patricia Hughes and Rick FriedmanPDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 563-567; DOI: https://doi.org/10.5731/pdajpst.2011.00820
G
Gardner, Shea
- You have accessDetection of Adventitious Viruses from Biologicals Using a Broad-Spectrum Microbial Detection ArrayCrystal Jaing, Shea Gardner, Kevin McLoughlin, James B. Thissen and Tom SlezakPDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 668-674; DOI: https://doi.org/10.5731/pdajpst.2011.00838
Gregersen, Jens-Peter
- You have accessTheory and Practice of Conventional Adventitious Virus TestingJens-Peter GregersenPDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 634-644; DOI: https://doi.org/10.5731/pdajpst.2011.00832
H
Hendricks, Linda C.
- You have accessCase Study of Apparent Virus Contamination in Biopharmaceutical Product at CentocorLinda C. Hendricks and Dominick A. VacantePDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 612-613; DOI: https://doi.org/10.5731/pdajpst.2011.00825
Hughes, Patricia
- You have accessRisk Mitigation Strategies for Viral Contamination of Biotechnology Products: Consideration of Best PracticesAmy S. Rosenberg, Barry Cherney, Kurt Brorson, Kathleen Clouse, Steven Kozlowski, Patricia Hughes and Rick FriedmanPDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 563-567; DOI: https://doi.org/10.5731/pdajpst.2011.00820
- You have accessIntroduction to Workshop: Adventitious Viruses in Biologics—Detection and Mitigation StrategiesArifa S. Khan, Patricia Hughes and Michael WiebePDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 544-546; DOI: https://doi.org/10.5731/pdajpst.2011.00817
I
Ill, Richard C.
- You have accessEvaluation of a Single-Platform, Rapid, Nucleic Acid–Based Technology for Detection of Adventitious Contaminants of Cell CultureHouman Dehghani, Bill Lawrence and Richard C. IllPDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 675-680; DOI: https://doi.org/10.5731/pdajpst.2011.00840
J
Jaing, Crystal
- You have accessDetection of Adventitious Viruses from Biologicals Using a Broad-Spectrum Microbial Detection ArrayCrystal Jaing, Shea Gardner, Kevin McLoughlin, James B. Thissen and Tom SlezakPDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 668-674; DOI: https://doi.org/10.5731/pdajpst.2011.00838
Jones, Nathan
- You have accessIdentification and Remediation of a Cell Culture Virus ContaminationNathan JonesPDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 615; DOI: https://doi.org/10.5731/pdajpst.2011.00822
K
Khan, Arifa S.
- You have accessCurrent Testing Methods and Challenges for Detection of Adventitious VirusesArifa S. KhanPDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 627-633; DOI: https://doi.org/10.5731/pdajpst.2011.00831
- You have accessIntroduction to Workshop: Adventitious Viruses in Biologics—Detection and Mitigation StrategiesArifa S. Khan, Patricia Hughes and Michael WiebePDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 544-546; DOI: https://doi.org/10.5731/pdajpst.2011.00817
- You have accessDetection of Latent Retroviruses in Vaccine-related Cell Substrates: Investigation of RT Activity Produced by Chemical Induction of Vero CellsHailun Ma and Arifa S. KhanPDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 685-689; DOI: https://doi.org/10.5731/pdajpst.2011.00843
Khan, Fazal
- You have accessMouse Minute Virus (MMV) Contamination—A Case Study: Detection, Root Cause Determination, and Corrective ActionsMark Moody, Washington Alves, Jose Varghese and Fazal KhanPDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 580-588; DOI: https://doi.org/10.5731/pdajpst.2011.00824
King, Kathryn
- You have accessPDA Cell Substrate Task Force: Emerging Technologies for Virus Detection Technical Document—A Progress ReportKathryn King and Michael WiebePDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 693; DOI: https://doi.org/10.5731/pdajpst.2011.00844
Kiss, Robert
- You have accessBreakout Session A: Elimination or Treatment of High-risk Raw MaterialsRobert Kiss and Roman DrewsPDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 767-777; DOI: https://doi.org/10.5731/pdajpst.2011.00850
Kiss, Robert D.
- You have accessPracticing Safe Cell Culture: Applied Process Designs for Minimizing Virus Contamination RiskRobert D. KissPDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 715-729; DOI: https://doi.org/10.5731/pdajpst.2011.00852
Kljavin, Ivar J.
- You have accessBroadening Our Expectations for Viral Safety Risk MitigationIvar J. KljavinPDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 645-653; DOI: https://doi.org/10.5731/pdajpst.2011.00833
Kolman, J. L.
- You have accessMassively Parallel Sequencing for the Detection of Adventitious VirusesJ. L. KolmanPDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 663-667; DOI: https://doi.org/10.5731/pdajpst.2011.00836
Kozlowski, Steven
- You have accessRisk Mitigation Strategies for Viral Contamination of Biotechnology Products: Consideration of Best PracticesAmy S. Rosenberg, Barry Cherney, Kurt Brorson, Kathleen Clouse, Steven Kozlowski, Patricia Hughes and Rick FriedmanPDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 563-567; DOI: https://doi.org/10.5731/pdajpst.2011.00820
Krause, Philip R.
- You have accessUse of DOP-PCR in Non-Specific Virus DetectionChristine Uhlenhaut, Shasta McClenahan and Philip R. KrausePDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 681-684; DOI: https://doi.org/10.5731/pdajpst.2011.00842
- You have accessRegulatory Approaches for Control of Viral Contamination of VaccinesShasta McClenahan, Christine Uhlenhaut and Philip R. KrausePDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 557-562; DOI: https://doi.org/10.5731/pdajpst.2011.00819
L
Lawrence, Bill
- You have accessEvaluation of a Single-Platform, Rapid, Nucleic Acid–Based Technology for Detection of Adventitious Contaminants of Cell CultureHouman Dehghani, Bill Lawrence and Richard C. IllPDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 675-680; DOI: https://doi.org/10.5731/pdajpst.2011.00840
Lubiniecki, Anthony
- You have accessSummary of Breakout Session EKurt Brorson and Anthony LubinieckiPDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 616-619; DOI: https://doi.org/10.5731/pdajpst.2011.00828
Lubiniecki, Anthony S.
- You have accessEvolution of Approaches to Viral Safety Issues for Biological ProductsAnthony S. LubinieckiPDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 547-556; DOI: https://doi.org/10.5731/pdajpst.2011.00818
Lutgen, Mark
- You have accessChlorine Dioxide Remediation of a Virus-Contaminated Manufacturing FacilityMark LutgenPDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 620-624; DOI: https://doi.org/10.5731/pdajpst.2011.00830
M
Ma, Hailun
- You have accessDetection of Latent Retroviruses in Vaccine-related Cell Substrates: Investigation of RT Activity Produced by Chemical Induction of Vero CellsHailun Ma and Arifa S. KhanPDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 685-689; DOI: https://doi.org/10.5731/pdajpst.2011.00843
McClenahan, Shasta
- You have accessUse of DOP-PCR in Non-Specific Virus DetectionChristine Uhlenhaut, Shasta McClenahan and Philip R. KrausePDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 681-684; DOI: https://doi.org/10.5731/pdajpst.2011.00842
- You have accessRegulatory Approaches for Control of Viral Contamination of VaccinesShasta McClenahan, Christine Uhlenhaut and Philip R. KrausePDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 557-562; DOI: https://doi.org/10.5731/pdajpst.2011.00819
McLoughlin, Kevin
- You have accessDetection of Adventitious Viruses from Biologicals Using a Broad-Spectrum Microbial Detection ArrayCrystal Jaing, Shea Gardner, Kevin McLoughlin, James B. Thissen and Tom SlezakPDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 668-674; DOI: https://doi.org/10.5731/pdajpst.2011.00838
Moody, Mark
- You have accessMouse Minute Virus (MMV) Contamination—A Case Study: Detection, Root Cause Determination, and Corrective ActionsMark Moody, Washington Alves, Jose Varghese and Fazal KhanPDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 580-588; DOI: https://doi.org/10.5731/pdajpst.2011.00824
Morrow, Michael
- You have accessNanostring's nCounter—A True Digital Target Profiling TechnologyMichael Morrow and John DonaldsonPDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 692; DOI: https://doi.org/10.5731/pdajpst.2011.00841
Munroe, David
- You have accessA Microarray Platform for Virus Detection and IdentificationDavid MunroePDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 691; DOI: https://doi.org/10.5731/pdajpst.2011.00839
N
Norwood, Laurie P.
- You have accessSummary of Breakout Session F: Facility and Equipment Decontamination StrategiesLaurie P. Norwood and Kalavati SuvarnaPDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 625-626; DOI: https://doi.org/10.5731/pdajpst.2011.00829
O
Onions, David
- You have accessOverview of Emerging Technologies To Detect Adventitious AgentsDavid OnionsPDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 654-659; DOI: https://doi.org/10.5731/pdajpst.2011.00834
P
Pennathur, Sridhar
- You have accessApplication of Risk Assessments in the Design of the Overall Viral Control Strategy Used during the Manufacture and Testing of Live Virus VaccinesSridhar PennathurPDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 730-736; DOI: https://doi.org/10.5731/pdajpst.2011.00851
Piérard, Isabelle
- You have accessContamination by Porcine Circovirus Type 1: Findings, Investigations, and LearningsIsabelle PiérardPDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 614; DOI: https://doi.org/10.5731/pdajpst.2011.00826
R
Ranucci, C. S.
- You have accessAdventitious Agent Risk Assessment Case Study: Evaluation of RotaTeq® for the Presence of Porcine CircovirusC. S. Ranucci, T. Tagmyer and P. DuncanPDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 589-598; DOI: https://doi.org/10.5731/pdajpst.2011.00827
Rosenberg, Amy S.
- You have accessRisk Mitigation Strategies for Viral Contamination of Biotechnology Products: Consideration of Best PracticesAmy S. Rosenberg, Barry Cherney, Kurt Brorson, Kathleen Clouse, Steven Kozlowski, Patricia Hughes and Rick FriedmanPDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 563-567; DOI: https://doi.org/10.5731/pdajpst.2011.00820
S
Sampath, Rangarajan
- You have accessAdvanced Techniques for Detection and Identification of Viral Contaminants Using the Ibis PLEX-ID Universal BiosensorRangarajan SampathPDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 690; DOI: https://doi.org/10.5731/pdajpst.2011.00837
Sausville, Robert
- You have accessSummary of Breakout Session B: Regulatory Expectations for CGMPRobert Sausville and Chantal CazeaultPDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 713-714; DOI: https://doi.org/10.5731/pdajpst.2011.00847
Skrine, Jim
- You have accessA Biotech Production Facility Contamination Case Study—Minute Mouse VirusJim SkrinePDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 599-611; DOI: https://doi.org/10.5731/pdajpst.2011.00823
Slezak, Tom
- You have accessDetection of Adventitious Viruses from Biologicals Using a Broad-Spectrum Microbial Detection ArrayCrystal Jaing, Shea Gardner, Kevin McLoughlin, James B. Thissen and Tom SlezakPDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 668-674; DOI: https://doi.org/10.5731/pdajpst.2011.00838
Suvarna, Kalavati
- You have accessSummary of Breakout Session F: Facility and Equipment Decontamination StrategiesLaurie P. Norwood and Kalavati SuvarnaPDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 625-626; DOI: https://doi.org/10.5731/pdajpst.2011.00829
T
Tagmyer, T.
- You have accessAdventitious Agent Risk Assessment Case Study: Evaluation of RotaTeq® for the Presence of Porcine CircovirusC. S. Ranucci, T. Tagmyer and P. DuncanPDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 589-598; DOI: https://doi.org/10.5731/pdajpst.2011.00827
Thissen, James B.
- You have accessDetection of Adventitious Viruses from Biologicals Using a Broad-Spectrum Microbial Detection ArrayCrystal Jaing, Shea Gardner, Kevin McLoughlin, James B. Thissen and Tom SlezakPDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 668-674; DOI: https://doi.org/10.5731/pdajpst.2011.00838
U
Uhlenhaut, Christine
- You have accessUse of DOP-PCR in Non-Specific Virus DetectionChristine Uhlenhaut, Shasta McClenahan and Philip R. KrausePDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 681-684; DOI: https://doi.org/10.5731/pdajpst.2011.00842
- You have accessRegulatory Approaches for Control of Viral Contamination of VaccinesShasta McClenahan, Christine Uhlenhaut and Philip R. KrausePDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 557-562; DOI: https://doi.org/10.5731/pdajpst.2011.00819
V
Vacante, Dominick A.
- You have accessCase Study of Apparent Virus Contamination in Biopharmaceutical Product at CentocorLinda C. Hendricks and Dominick A. VacantePDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 612-613; DOI: https://doi.org/10.5731/pdajpst.2011.00825
Varghese, Jose
- You have accessMouse Minute Virus (MMV) Contamination—A Case Study: Detection, Root Cause Determination, and Corrective ActionsMark Moody, Washington Alves, Jose Varghese and Fazal KhanPDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 580-588; DOI: https://doi.org/10.5731/pdajpst.2011.00824
W
Wiebe, Michael
- You have accessIntroduction to Workshop: Adventitious Viruses in Biologics—Detection and Mitigation StrategiesArifa S. Khan, Patricia Hughes and Michael WiebePDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 544-546; DOI: https://doi.org/10.5731/pdajpst.2011.00817
- You have accessPDA Cell Substrate Task Force: Emerging Technologies for Virus Detection Technical Document—A Progress ReportKathryn King and Michael WiebePDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 693; DOI: https://doi.org/10.5731/pdajpst.2011.00844
Willkommen, Hannelore
- You have accessBreakout Session C Summary: Current Virus Detection MethodsAndrew P. Byrnes and Hannelore WillkommenPDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 660-662; DOI: https://doi.org/10.5731/pdajpst.2011.00835
In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 65, Issue 6
November/December 2011
