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OtherConference Proceeding

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
C. S. Ranucci
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  • For correspondence: colette.ranucci@merck.com
T. Tagmyer
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P. Duncan
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Article Information

vol. 65 no. 6 589-598
DOI 
https://doi.org/10.5731/pdajpst.2011.00827
PubMed 
22294581

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online January 4, 2012.

Copyright & Usage 
© PDA, Inc. 2011

Author Information

  1. C. S. Ranucci1,*,
  2. T. Tagmyer1 and
  3. P. Duncan2
  1. 1Vaccine Manufacturing Science and Commercialization and
  2. 2Bioprocess Research and Development, Merck & Co., Inc. West Point, PA
  1. ↵* Corresponding author: WP17-101, 770 Sumneytown Pike, P. O. Box 4, West Point, PA 19486. E-mail: colette.ranucci{at}merck.com.
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PDA Journal of Pharmaceutical Science and Technology: 65 (6)
PDA Journal of Pharmaceutical Science and Technology
Vol. 65, Issue 6
November/December 2011
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Adventitious Agent Risk Assessment Case Study: Evaluation of RotaTeq® for the Presence of Porcine Circovirus
C. S. Ranucci, T. Tagmyer, P. Duncan
PDA Journal of Pharmaceutical Science and Technology Nov 2011, 65 (6) 589-598; DOI: 10.5731/pdajpst.2011.00827

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Adventitious Agent Risk Assessment Case Study: Evaluation of RotaTeq® for the Presence of Porcine Circovirus
C. S. Ranucci, T. Tagmyer, P. Duncan
PDA Journal of Pharmaceutical Science and Technology Nov 2011, 65 (6) 589-598; DOI: 10.5731/pdajpst.2011.00827
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  • Article
    • Abstract
    • Introduction
    • Definition of Test Algorithm and Test Methods for Evaluation of RotaTeq®
    • Initial Screening for and Quantitation of PCV-1 and PCV-2 DNA
    • Detection of Long PCV DNA Sequences
    • Detection of Infectious PCV
    • Test Article Preparation
    • Application of Test Algorithm to RotaTeq®
    • Determination of the Source of the PCV-2 DNA Fragments Detected in RotaTeq®
    • Clinical Relevance of PCV-2 DNA Fragments Detected in RotaTeq®
    • Summary
    • Acknowledgments
    • References
  • Figures & Data
  • References
  • Info & Metrics
  • PDF

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