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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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Abstract

CONFERENCE PROCEEDING Proceedings of the PDA/FDA Adventitious Viruses in Biologics: Detection and Mitigation Strategies Workshop in Bethesda, MD, USA; December 1–3, 2010

Guest Editors: Arifa Khan (Bethesda, MD), Patricia Hughes (Bethesda, MD) and Michael Wiebe (San Francisco, CA)

In June of 2010, results of metagenomic and panmicrobial microarray analysis of a number of commercially available vaccine products were published, identifying the unexpected presence of porcine circovirus (PCV) in of one of the vaccine products tested. This testing did not detect any sequences of contaminating viruses in RotaTeq® (rotavirus vaccine, live, oral, pentavalent, RV5, Merck & Co., Inc., Whitehouse Station, NJ). To confirm this finding, Merck developed and applied a number of polymerase chain reaction–based analytical methods and a test algorithm to systematically demonstrate the absence of infectious PCV in RotaTeq®. This paper will describe the methodology and rationale developed to thoroughly assess key starting materials, product intermediates, and final product to demonstrate the absence of infectious PCV, and the continued quality of this product. This approach could be applied to assess the validity of other adventitious agent risks encountered in biological processes and products.

  • Animal-derived raw materials
  • Porcine circovirus
  • Adventitious agents
  • © PDA, Inc. 2011
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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
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  • References
  • PDF

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