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Research ArticleResearch

Mycoplasma Clearance and Risk Analysis in a Model Bioprocess

Julie Wang, Sarah Johnson, Matthew Brown, Scott Lute, Cyrus Agarabi, Alena Dabrazhynetskaya, Vladimir Chizhikov and Kurt Brorson
PDA Journal of Pharmaceutical Science and Technology March 2017, 71 (2) 99-114; DOI: https://doi.org/10.5731/pdajpst.2016.007054
Julie Wang
1Division II/Office of Biotechnology Products/Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20903. Views expressed in this article represent those of the authors and not necessarily policy or guidance from the U.S. Food and Drug Administration; and
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Sarah Johnson
1Division II/Office of Biotechnology Products/Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20903. Views expressed in this article represent those of the authors and not necessarily policy or guidance from the U.S. Food and Drug Administration; and
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Matthew Brown
1Division II/Office of Biotechnology Products/Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20903. Views expressed in this article represent those of the authors and not necessarily policy or guidance from the U.S. Food and Drug Administration; and
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Scott Lute
1Division II/Office of Biotechnology Products/Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20903. Views expressed in this article represent those of the authors and not necessarily policy or guidance from the U.S. Food and Drug Administration; and
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Cyrus Agarabi
1Division II/Office of Biotechnology Products/Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20903. Views expressed in this article represent those of the authors and not necessarily policy or guidance from the U.S. Food and Drug Administration; and
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Alena Dabrazhynetskaya
2Division of Viral Products/Office of Vaccine Research and Review/Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20903
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Vladimir Chizhikov
2Division of Viral Products/Office of Vaccine Research and Review/Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20903
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Kurt Brorson
1Division II/Office of Biotechnology Products/Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20903. Views expressed in this article represent those of the authors and not necessarily policy or guidance from the U.S. Food and Drug Administration; and
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  • For correspondence: Kurt.Brorson@fda.hhs.gov
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Article Information

vol. 71 no. 2 99-114
DOI 
https://doi.org/10.5731/pdajpst.2016.007054
PubMed 
28089962

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online April 10, 2017.

Article Versions

  • previous version (January 15, 2017 - 09:37).
  • You are viewing the most recent version of this article.
Copyright & Usage 
© PDA, Inc. 2017

Author Information

  1. Julie Wang1,
  2. Sarah Johnson1,
  3. Matthew Brown1,
  4. Scott Lute1,
  5. Cyrus Agarabi1,
  6. Alena Dabrazhynetskaya2,
  7. Vladimir Chizhikov2 and
  8. Kurt Brorson1,*
  1. 1Division II/Office of Biotechnology Products/Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20903. Views expressed in this article represent those of the authors and not necessarily policy or guidance from the U.S. Food and Drug Administration; and
  2. 2Division of Viral Products/Office of Vaccine Research and Review/Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20903
  1. ↵* Corresponding Author: Kurt A. Brorson. Telephone: 301-796-0016; e-mail: Kurt.Brorson{at}fda.hhs.gov
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PDA Journal of Pharmaceutical Science and Technology: 71 (2)
PDA Journal of Pharmaceutical Science and Technology
Vol. 71, Issue 2
March/April 2017
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Mycoplasma Clearance and Risk Analysis in a Model Bioprocess
Julie Wang, Sarah Johnson, Matthew Brown, Scott Lute, Cyrus Agarabi, Alena Dabrazhynetskaya, Vladimir Chizhikov, Kurt Brorson
PDA Journal of Pharmaceutical Science and Technology Mar 2017, 71 (2) 99-114; DOI: 10.5731/pdajpst.2016.007054

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Mycoplasma Clearance and Risk Analysis in a Model Bioprocess
Julie Wang, Sarah Johnson, Matthew Brown, Scott Lute, Cyrus Agarabi, Alena Dabrazhynetskaya, Vladimir Chizhikov, Kurt Brorson
PDA Journal of Pharmaceutical Science and Technology Mar 2017, 71 (2) 99-114; DOI: 10.5731/pdajpst.2016.007054
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Keywords

  • Mycoplasma
  • Acholeplasma laidlawii
  • Bioprocessing
  • Protein A chromatography
  • Solvent/detergent
  • Low-pH hold
  • Spike/clearance
  • Cell culture

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