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Research ArticleResearch

Bioprocess: Robustness with Respect to Mycoplasma Species

Talia Faison, Julie Wang, Sarah Johnson, Matthew Brown, Meng-Jung Chiang, Sherri Dolan, Carl Breuning, Sai Rashmika Velugula-Yellela, Scott Lute, Erica J. Fratz-Berilla and Kurt Brorson
PDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 201-212; DOI: https://doi.org/10.5731/pdajpst.2018.009613
Talia Faison
Division 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.
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Julie Wang
Division 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.
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Sarah Johnson
Division 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.
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Matthew Brown
Division 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.
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Meng-Jung Chiang
Division 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.
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Sherri Dolan
Division 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.
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Carl Breuning
Division 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.
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Sai Rashmika Velugula-Yellela
Division 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.
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Scott Lute
Division 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.
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Erica J. Fratz-Berilla
Division 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.
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  • For correspondence: Erica.berilla@fda.hhs.gov
Kurt Brorson
Division 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.
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Article Information

vol. 74 no. 2 201-212
DOI 
https://doi.org/10.5731/pdajpst.2018.009613
PubMed 
31519782

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online April 9, 2020.

Article Versions

  • previous version (September 13, 2019 - 09:11).
  • You are viewing the most recent version of this article.
Copyright & Usage 
© PDA, Inc. 2020

Author Information

  1. Talia Faison,
  2. Julie Wang#a,
  3. Sarah Johnson,
  4. Matthew Brown#b,
  5. Meng-Jung Chiang,
  6. Sherri Dolan#c,
  7. Carl Breuning#c,
  8. Sai Rashmika Velugula-Yellela,
  9. Scott Lute,
  10. Erica J. Fratz-Berilla* and
  11. Kurt Brorson
  1. Division 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.
  1. ↵*Corresponding Author: Division 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. Telephone: 240-402-3333; E-mail: Erica.berilla{at}fda.hhs.gov
  • ↵#a Current Address: Johns Hopkins University, 3400 N. Charles Street, Baltimore, MD 21218.

  • ↵#b Current Address: Boehringer Ingelheim Freemont, Inc, 6701 Kaiser Drive, Freemont, CA 94555.

  • ↵#c Current Address: Sartorius Stedim Biotech North America, Inc., 5 Orville Drive, Bohemia, NY.

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This article has been cited by the following articles in journals that are participating in Crossref Cited-by Linking.

  • Impacts on product quality attributes of monoclonal antibodies produced in CHO cell bioreactor cultures during intentional mycoplasma contamination events
    Erica J. Fratz‐Berilla, Phillip Angart, Ryan J. Graham, David N. Powers, Adil Mohammad, Casey Kohnhorst, Talia Faison, Sai Rashmika Velugula‐Yellela, Nicholas Trunfio, Cyrus Agarabi
    Biotechnology and Bioengineering 2020 117 9
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PDA Journal of Pharmaceutical Science and Technology: 74 (2)
PDA Journal of Pharmaceutical Science and Technology
Vol. 74, Issue 2
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Bioprocess: Robustness with Respect to Mycoplasma Species
Talia Faison, Julie Wang, Sarah Johnson, Matthew Brown, Meng-Jung Chiang, Sherri Dolan, Carl Breuning, Sai Rashmika Velugula-Yellela, Scott Lute, Erica J. Fratz-Berilla, Kurt Brorson
PDA Journal of Pharmaceutical Science and Technology Mar 2020, 74 (2) 201-212; DOI: 10.5731/pdajpst.2018.009613

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Bioprocess: Robustness with Respect to Mycoplasma Species
Talia Faison, Julie Wang, Sarah Johnson, Matthew Brown, Meng-Jung Chiang, Sherri Dolan, Carl Breuning, Sai Rashmika Velugula-Yellela, Scott Lute, Erica J. Fratz-Berilla, Kurt Brorson
PDA Journal of Pharmaceutical Science and Technology Mar 2020, 74 (2) 201-212; DOI: 10.5731/pdajpst.2018.009613
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Keywords

  • Mycoplasma
  • Acholeplasma laidlawii
  • Mycoplasma arginini
  • Mycoplasma orale
  • Bioprocessing
  • Protein A chromatography
  • Chromatography column/media
  • Solvent/detergent
  • Low-pH hold
  • Spike/clearance
  • Cell culture
  • Viral filter
  • Media filter
  • Ultraviolet-C irradiation

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